Primary Open-Angle GlaucomaPhase 2NCT00572455

Safety and Efficacy of PF-04217329 in Patients With Glaucoma or Elevated Eye Pressure.

A Phase 2 study testing PF-04217329 - Lowest Dose, PF-04217329 - Low Dose and PF-04217329 - Middle Dose in people with Primary Open-Angle Glaucoma and Ocular Hypertension, run by Pfizer at 23 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To evaluate the safety and efficacy of PF-04217329. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Primary Open-Angle Glaucoma, Ocular Hypertension
What is being tested?: PF-04217329 - Lowest Dose, PF-04217329 - Low Dose and PF-04217329 - Middle Dose
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 318 participants
Where: 23 sitesUnited States
Study dates: 11 Dec 2007to 26 Jun 2009
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosis of primary open-angle glaucoma (including pigmentary or pseudoexfoliative) or ocular hypertension in 1 or both eyes.
Qualifying intraocular pressure (IOP) in the same eye at the Eligibility 1 and 2 measurements.

Who cannot join

Closed/barely open anterior chamber angle or a history of acute angle closure in either eye.
Anticipate the need to initiate or modify medication (systemic or topical) that is known to affect intraocular pressure (IOP) during the study period.

Trial locations and contacts

23 sites in 1 country.

City, postcode or hospital

23 sites in 1 country

United States23 sites

Sall Research Medical Center
Artesia, California, 90701
Coastal Research Associates,LLC
Atlanta, Georgia, 30339
Omni Eye Services of Atlanta
Atlanta, Georgia, 30342
Texan Eye Care, PA
Austin, Texas, 78746
Eye Physicians of Austin
Austin, Texas, 78756
Glaucoma Care Center at Century Eye Care
Bristol, Pennsylvania, 19007
Bluestein Custom Vision
Charleston, South Carolina, 29414-5893
Charlotte Eye Ear Nose and Throat Associates, PA
Charlotte, North Carolina, 28210
Atlantic Institute of Clinical Research
Daytona Beach, Florida, 32114
Florida Health Care Plans
Daytona Beach, Florida, 32114
The Eye Group of Southern Indiana
Evansville, Indiana, 47710
Eye Associates of Fort Myers
Fort Myers, Florida, 33901
Cornerstone Eye Care
High Point, North Carolina, 27262
Taustine Eye Center
Louisville, Kentucky, 40217
Total Eye Care, PA
Memphis, Tennessee, 38119
Eye Care Centers Management, Inc.
Morrow, Georgia, 30260
Eye Research Foundation
Newport Beach, California, 92663
International Eye Associates, PA
Ormond Beach, Florida, 32174
North Bay Eye Associates, Inc.
Petaluma, California, 94954
Wills Eye Institute
Philadelphia, Pennsylvania, 19107
Centre For Health Care
Poway, California, 92064
Rochester Ophthalmological Group, PC
Rochester, New York, 14618
Mark J. Weiss, MD. Inc.
Tulsa, Oklahoma, 74104

Other trials in United States

About this study

Official title: A 2-STAGE, PHASE 2, DOUBLE-MASKED, RANDOMIZED, VEHICLE CONTROLLED, DOSE RESPONSE TRIAL OF PF-04217329 AND THE MARKETED FORMULATION OF LATANOPROST IN PATIENTS WITH PRIMARY OPEN ANGLE GLAUCOMA OR OCULAR HYPERTENSION

To evaluate the safety and efficacy of PF-04217329.

Conditions: Primary Open-Angle Glaucoma, Ocular Hypertension
Being tested: PF-04217329 - Lowest Dose, PF-04217329 - Low Dose, PF-04217329 - Middle Dose, PF-04217329 - High Middle Dose, PF-04217329 - High Dose
Keywords: Open-Angle Glaucoma, Ocular Hypertension
Medical subject headings: Glaucoma, Open-Angle, Ocular Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PF-04217329 - Lowest DoseDrug
1 drop of lowest dose PF-04217329, once a day, per dosed eye for duration of study.
PF-04217329 - Low DoseDrug
1 drop of low dose PF-04217329, once a day, per dosed eye for duration of study.
PF-04217329 - Middle DoseDrug
1 drop of middle dose PF-04217329, once a day, per dosed eye for duration of study.
PF-04217329 - High Middle DoseDrug
1 drop of high middle dose PF-04217329, once a day, per dosed eye for duration of study.
PF-04217329 - High DoseDrug
1 drop of high dose PF-04217329, once a day, per dosed eye for duration of study.
PF-4217329 - Highest DoseDrug
1 drop of highest dose PF-04217329, once a day, per dosed eye for duration of study.
PF-04217329 - VehicleDrug
1 drop of PF-04217329 vehicle, once a day, per dosed eye for duration of study.
Latanoprost VehicleDrug
1 drop of latanoprost vehicle, once a day, per dosed eye for duration of study.
PF-04217329 - Low DoseDrug
Five minutes after latanoprost vehicle, 1 drop of low dose PF-04217329, once a day, per dosed eye for duration of study.
Latanoprost VehicleDrug
1 drop of latanoprost vehicle, once a day, per dosed eye for duration of study.
PF-04217329 - Middle DoseDrug
Five minutes after latanoprost vehicle, 1 drop of middle dose PF-04217329, once a day, per dosed eye for duration of study.
Latanoprost VehicleDrug
1 drop of latanoprost vehicle, once a day, per dosed eye for duration of study.
PF-04217329 - High DoseDrug
Five minutes after latanoprost vehicle, 1 drop of high dose PF-04217329, once a day, per dosed eye for duration of study.
Latanoprost 0.005%Drug
1 drop of latanoprost 0.005%, once a day, per dosed eye for duration of study.
PF-04217329 - Low DoseDrug
Five minutes after latanoprost 0.005%, 1 drop of low dose PF-04217329, once a day, per dosed eye for duration of study.
Latanoprost 0.005%Drug
1 drop of latanoprost 0.005%, once a day, per dosed eye for duration of study.
PF-04217329 - Middle DoseDrug
Five minutes after latanoprost 0.005%, 1 drop middle dose PF-04217329, once a day, per dosed eye for duration of study.
Latanoprost 0.005%Drug
1 drop of latanoprost 0.005%, once a day, per dosed eye for duration of study.
PF-04217329 - High DoseDrug
Five minutes after latanoprost 0.005%, 1 drop high dose PF-04217329, once a day, per dosed eye for duration of study.
Latanoprost 0.005%Drug
1 drop of latanoprost 0.005%, once a day, per dosed eye for duration of study.
PF-04217329 - VehicleDrug
Five minutes after latanoprost 0.005%, 1 drop of PF-04217329 vehicle, once a day, per dosed eye for duration of study.

Study groups in NCT00572455
Study group	Role	What they receive
Stage 1: PF-04217329 - Lowest Dose	Experimental	Not described Receives: Drug: PF-04217329 - Lowest Dose
Stage 1: PF-04217329 - Low Dose	Experimental	Not described Receives: Drug: PF-04217329 - Low Dose
Stage 1: PF-04217329 - Middle Dose	Experimental	Not described Receives: Drug: PF-04217329 - Middle Dose
Stage 1: PF-04217329 - High Middle Dose	Experimental	Not described Receives: Drug: PF-04217329 - High Middle Dose
Stage 1: PF-04217329 - High Dose	Experimental	Not described Receives: Drug: PF-04217329 - High Dose
Stage 1: PF-02417329 - Highest Dose	Experimental	Not described Receives: Drug: PF-4217329 - Highest Dose
Stage 1: PF-04217329 - Vehicle	Experimental	Not described Receives: Drug: PF-04217329 - Vehicle
Stage 2: PF-04217329 - Low Dose + Latanoprost Vehicle	Experimental	Not described Receives: Drug: Latanoprost Vehicle; Drug: PF-04217329 - Low Dose
Stage 2: PF-04217329 - Middle Dose + Latanoprost Vehicle	Experimental	Not described Receives: Drug: Latanoprost Vehicle; Drug: PF-04217329 - Middle Dose
Stage 2: PF-04217329 - High Dose + Latanoprost Vehicle	Experimental	Not described Receives: Drug: Latanoprost Vehicle; Drug: PF-04217329 - High Dose
Stage 2: PF-04217329 - Low Dose + Latanoprost 0.005%	Experimental	Not described Receives: Drug: Latanoprost 0.005%; Drug: PF-04217329 - Low Dose
Stage 2: PF-04217329 - Middle Dose + Latanoprost 0.005%	Experimental	Not described Receives: Drug: Latanoprost 0.005%; Drug: PF-04217329 - Middle Dose
Stage 2: PF-04217329 - High Dose + Latanoprost 0.005%	Experimental	Not described Receives: Drug: Latanoprost 0.005%; Drug: PF-04217329 - High Dose
Stage 2: PF-04217329 - Vehicle + Latanoprost 0.005%	Experimental	Not described Receives: Drug: Latanoprost 0.005%; Drug: PF-04217329 - Vehicle

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Mean Diurnal Intra Ocular Pressure (IOP) in Study Eye at Day 14: Stage I
Diurnal IOP was defined as the mean IOP over 24 hours. IOP was measured using Goldmann applanation tonometer. IOP was measured in both the eyes, and the eye with higher IOP reading at the 2 eligibility visits was referred as 'study eye' for efficacy assessment. If both the measurements were equal, right eye was selected as the study eye. IOP was measured twice in the same eye, and if the difference between 2 measurements was less than or equal to 2 millimeter of mercury (mmHg), the mean of the 2 readings was recorded as the IOP at that time point. If the difference between 2 readings was greater than 2 mmHg, a third consecutive reading was taken and the median IOP was recorded as the IOP at that time point. Mean IOP was reported as the average of individual participants' mean or median IOP values. Change from baseline = diurnal IOP at baseline - diurnal IOP at Day 14.
Measured: Stage I: Baseline, Day 14
Change From Baseline in Mean Diurnal Intra Ocular Pressure (IOP) in Study Eye at Day 28: Stage II
Diurnal IOP was defined as the mean IOP over 24 hours. IOP was measured using Goldmann applanation tonometer. IOP was measured in both the eyes, and the eye with higher IOP reading at the 2 eligibility visits was referred as 'study eye' for efficacy assessment. If both the measurements were equal, right eye was selected as the study eye. IOP was measured twice in the same eye, and if the difference between 2 measurements was less than or equal to 2 mmHg, the mean of the 2 readings was recorded as the IOP at that time point. If the difference between 2 readings was greater than 2 mmHg, a third consecutive reading was taken and the median IOP was recorded as the IOP at that time point. Mean IOP was reported as the average of individual participants' mean or median IOP values. Change from baseline = diurnal IOP at baseline - diurnal IOP at Day 28.
Measured: Stage II: Baseline, Day 28
Number of Participants With Treatment Emergent Ocular Adverse Events (AEs): Stage I
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study medication and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Ocular AEs were the events which were localized in the ocular region.
Measured: Stage I: Day 1 up to 28 days after last dose of study medication (up to 44 days)
Number of Participants With Treatment Emergent Ocular Adverse Events (AEs): Stage II
An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study medication and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Ocular AEs were the events which were localized in the ocular region.
Measured: Stage II: Day 1 up to 28 days after last dose of study medication (up to 59 days)

Secondary outcomes (6)

Mean Intra Ocular Pressure (IOP) in Study Eye: Stage I
IOP was measured using Goldmann applanation tonometer. IOP was measured in both the eyes, and the eye with higher IOP reading at the 2 eligibility visits was referred as 'study eye' for efficacy assessment. If both the measurements were equal, right eye was selected as the study eye. IOP was measured twice in the same eye, and if the difference between 2 measurements was less than or equal to 2 mmHg, the mean of the 2 readings was recorded as the IOP at that time point. If the difference between 2 readings was greater than 2 mmHg, a third consecutive reading was taken and the median IOP was recorded as the IOP at that time point. Mean IOP was reported as the average of individual participants' mean or median IOP values.
Measured: Stage I: 8 ante meridiem (AM) on Day 1, 8 AM, 10 AM, 1 post meridiem (PM), 4 PM on Day 7, and 14
Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I
IOP was measured using Goldmann applanation tonometer. IOP was measured in both eyes, and the eye with higher IOP reading at 2 eligibility visits was referred as 'study eye' for efficacy assessment. If both measurements were equal, right eye was selected as the study eye. IOP was measured twice in the same eye, and if the difference between 2 measurements was less than or equal to 2 mmHg, the mean of the 2 readings was recorded as the IOP at that time point. If the difference between 2 readings was greater than 2 mmHg, a third consecutive reading was taken and the median IOP was recorded as the IOP at that time point. Mean IOP was reported as the average of individual participants' mean or median IOP values. Change from baseline = baseline IOP - post-baseline IOP. Change at various post-dose time points was calculated from the baseline values at same time points on Day 0 (for example, value at 8 AM on Day 0 was used as baseline value for 8 AM value on Day 1, 7 and 14).
Measured: Stage I: 8 AM, 10 AM, 1 PM, 4 PM on Day 0 (Baseline), 8 AM on Day 1, 8 AM, 10 AM, 1 PM, 4 PM on Day 7, and 14
Mean Intra Ocular Pressure (IOP) in Study Eye: Stage II
IOP was measured using Goldmann applanation tonometer. IOP was measured in both the eyes, and the eye with higher IOP reading at the 2 eligibility visits was referred as 'study eye' for efficacy assessment. If both the measurements were equal, right eye was selected as the study eye. IOP was measured twice in the same eye, and if the difference between 2 measurements was less than or equal to 2 mmHg, the mean of the 2 readings was recorded as the IOP at that time point. If the difference between 2 readings was greater than 2 mmHg, a third consecutive reading was taken and the median IOP was recorded as the IOP at that time point. Mean IOP was reported as the average of individual participants' mean or median IOP values.
Measured: Stage II: 8 AM on Day 1; 8 AM, 10 AM, 1 PM, 4 PM on Days 7, 14, and 28
Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II
IOP was measured using Goldmann applanation tonometer. IOP was measured in both eyes, and the eye with higher IOP reading at 2 eligibility visits was referred as 'study eye' for efficacy assessment. If both measurements were equal, right eye was selected as the study eye. IOP was measured twice in the same eye, and if the difference between 2 measurements was less than or equal to 2 mmHg, the mean of the 2 readings was recorded as the IOP at that time point. If the difference between 2 readings was greater than 2 mmHg, a third consecutive reading was taken and the median IOP was recorded as the IOP at that time point. Mean IOP was reported as the average of individual participants' mean or median IOP values. Change from baseline = baseline IOP - post-baseline IOP. Change at various post-dose time points was calculated from the baseline values at same time points on Day 0 (for example, value at 8 AM on Day 0 was used as baseline value for 8 AM value on Day 1, 7, 14 and 28).
Measured: Stage II: 8 AM, 10 AM, 1 PM, and 4 PM on Day 0 (Baseline), 8 AM on Day 1; 8 AM, 10 AM, 1 PM, 4 PM on Days 7, 14, and 28
Percentage of Participants Reaching and Maintaining Target Intra Ocular Pressure (IOP): Stage I
Percentage of participants who reached an IOP of less than or equal to (<=) 18 mmHg by post-eligibility visit (Day 1) and maintained an IOP <= 18 mm Hg across all post-eligibility visits in Stage I were reported. IOP was measured using Goldmann applanation tonometer.
Measured: Stage I: Day 1 up to Day 14
Percentage of Participants Reaching and Maintaining Target Intra Ocular Pressure (IOP): Stage II
Percentage of participants who reached an IOP <= 18 mmHg by post-eligibility visit (Day 1) and maintained an IOP <= 18 mm Hg across all post-eligibility visits in Stage II were reported. IOP was measured using Goldmann applanation tonometer.
Measured: Stage II: Day 1 up to Day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Dec 200726 Jun 2009

First posted13 Dec 2007 (estimated)
Study start11 Dec 2007
Primary completion26 Jun 2009
Study completion26 Jun 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Primary Open-Angle GlaucomaStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 318 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00572455
Sponsor's protocol ID: A0191001
Status last verified: Apr 2021
First submitted: 11 Dec 2007
Last updated: 30 Apr 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Publications

Schachar RA, Raber S, Courtney R, Zhang M. A phase 2, randomized, dose-response trial of taprenepag isopropyl (PF-04217329) versus latanoprost 0.005% in open-angle glaucoma and ocular hypertension. Curr Eye Res. 2011 Sep;36(9):809-17. doi: 10.3109/02713683.2011.593725.
PubMed 21851167

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 30 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 2-STAGE, PHASE 2, DOUBLE-MASKED, RANDOMIZED, VEHICLE CONTROLLED, DOSE RESPONSE TRIAL OF PF-04217329 AND THE MARKETED FORMULATION OF LATANOPROST IN PATIENTS WITH PRIMARY OPEN ANGLE GLAUCOMA OR OCULAR HYPERTENSION
ClinicalTrials.gov ID: NCT00572455
Acronym / sponsor ID: A0191001
Conditions: Primary Open-Angle Glaucoma, Ocular Hypertension
Keywords: Open-Angle Glaucoma, Ocular Hypertension
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 318 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 11 Dec 2007 (actual)
Primary completion: 26 Jun 2009 (actual)
Study completion: 26 Jun 2009 (actual)
First posted: 13 Dec 2007 (estimated)
Results: Posted 30 Apr 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To evaluate the safety and efficacy of PF-04217329.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 14

Arm	Type	Receives
Stage 1: PF-04217329 - Lowest Dose	Experimental	Drug: PF-04217329 - Lowest Dose
Stage 1: PF-04217329 - Low Dose	Experimental	Drug: PF-04217329 - Low Dose
Stage 1: PF-04217329 - Middle Dose	Experimental	Drug: PF-04217329 - Middle Dose
Stage 1: PF-04217329 - High Middle Dose	Experimental	Drug: PF-04217329 - High Middle Dose
Stage 1: PF-04217329 - High Dose	Experimental	Drug: PF-04217329 - High Dose
Stage 1: PF-02417329 - Highest Dose	Experimental	Drug: PF-4217329 - Highest Dose
Stage 1: PF-04217329 - Vehicle	Experimental	Drug: PF-04217329 - Vehicle
Stage 2: PF-04217329 - Low Dose + Latanoprost Vehicle	Experimental	Drug: Latanoprost Vehicle, Drug: PF-04217329 - Low Dose
Stage 2: PF-04217329 - Middle Dose + Latanoprost Vehicle	Experimental	Drug: Latanoprost Vehicle, Drug: PF-04217329 - Middle Dose
Stage 2: PF-04217329 - High Dose + Latanoprost Vehicle	Experimental	Drug: Latanoprost Vehicle, Drug: PF-04217329 - High Dose
Stage 2: PF-04217329 - Low Dose + Latanoprost 0.005%	Experimental	Drug: Latanoprost 0.005%, Drug: PF-04217329 - Low Dose
Stage 2: PF-04217329 - Middle Dose + Latanoprost 0.005%	Experimental	Drug: Latanoprost 0.005%, Drug: PF-04217329 - Middle Dose
Stage 2: PF-04217329 - High Dose + Latanoprost 0.005%	Experimental	Drug: Latanoprost 0.005%, Drug: PF-04217329 - High Dose
Stage 2: PF-04217329 - Vehicle + Latanoprost 0.005%	Experimental	Drug: Latanoprost 0.005%, Drug: PF-04217329 - Vehicle

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Diagnosis of primary open-angle glaucoma (including pigmentary or pseudoexfoliative) or ocular hypertension in 1 or both eyes.
Qualifying intraocular pressure (IOP) in the same eye at the Eligibility 1 and 2 measurements.

Key exclusion criteria (2 listed)

Closed/barely open anterior chamber angle or a history of acute angle closure in either eye.
Anticipate the need to initiate or modify medication (systemic or topical) that is known to affect intraocular pressure (IOP) during the study period.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PF-04217329 - Lowest Dose1 drop of lowest dose PF-04217329, once a day, per dosed eye for duration of study.	Drug	Stage 1: PF-04217329 - Lowest Dose
PF-04217329 - Low Dose1 drop of low dose PF-04217329, once a day, per dosed eye for duration of study.	Drug	Stage 1: PF-04217329 - Low Dose
PF-04217329 - Middle Dose1 drop of middle dose PF-04217329, once a day, per dosed eye for duration of study.	Drug	Stage 1: PF-04217329 - Middle Dose
PF-04217329 - High Middle Dose1 drop of high middle dose PF-04217329, once a day, per dosed eye for duration of study.	Drug	Stage 1: PF-04217329 - High Middle Dose
PF-04217329 - High Dose1 drop of high dose PF-04217329, once a day, per dosed eye for duration of study.	Drug	Stage 1: PF-04217329 - High Dose
PF-4217329 - Highest Dose1 drop of highest dose PF-04217329, once a day, per dosed eye for duration of study.	Drug	Stage 1: PF-02417329 - Highest Dose
PF-04217329 - Vehicle1 drop of PF-04217329 vehicle, once a day, per dosed eye for duration of study.	Drug	Stage 1: PF-04217329 - Vehicle
Latanoprost Vehicle1 drop of latanoprost vehicle, once a day, per dosed eye for duration of study.	Drug	Stage 2: PF-04217329 - Low Dose + Latanoprost Vehicle
PF-04217329 - Low DoseFive minutes after latanoprost vehicle, 1 drop of low dose PF-04217329, once a day, per dosed eye for duration of study.	Drug	Stage 2: PF-04217329 - Low Dose + Latanoprost Vehicle
Latanoprost Vehicle1 drop of latanoprost vehicle, once a day, per dosed eye for duration of study.	Drug	Stage 2: PF-04217329 - Middle Dose + Latanoprost Vehicle
PF-04217329 - Middle DoseFive minutes after latanoprost vehicle, 1 drop of middle dose PF-04217329, once a day, per dosed eye for duration of study.	Drug	Stage 2: PF-04217329 - Middle Dose + Latanoprost Vehicle
Latanoprost Vehicle1 drop of latanoprost vehicle, once a day, per dosed eye for duration of study.	Drug	Stage 2: PF-04217329 - High Dose + Latanoprost Vehicle
PF-04217329 - High DoseFive minutes after latanoprost vehicle, 1 drop of high dose PF-04217329, once a day, per dosed eye for duration of study.	Drug	Stage 2: PF-04217329 - High Dose + Latanoprost Vehicle
Latanoprost 0.005%1 drop of latanoprost 0.005%, once a day, per dosed eye for duration of study.	Drug	Stage 2: PF-04217329 - Low Dose + Latanoprost 0.005%
PF-04217329 - Low DoseFive minutes after latanoprost 0.005%, 1 drop of low dose PF-04217329, once a day, per dosed eye for duration of study.	Drug	Stage 2: PF-04217329 - Low Dose + Latanoprost 0.005%
Latanoprost 0.005%1 drop of latanoprost 0.005%, once a day, per dosed eye for duration of study.	Drug	Stage 2: PF-04217329 - Middle Dose + Latanoprost 0.005%
PF-04217329 - Middle DoseFive minutes after latanoprost 0.005%, 1 drop middle dose PF-04217329, once a day, per dosed eye for duration of study.	Drug	Stage 2: PF-04217329 - Middle Dose + Latanoprost 0.005%
Latanoprost 0.005%1 drop of latanoprost 0.005%, once a day, per dosed eye for duration of study.	Drug	Stage 2: PF-04217329 - High Dose + Latanoprost 0.005%
PF-04217329 - High DoseFive minutes after latanoprost 0.005%, 1 drop high dose PF-04217329, once a day, per dosed eye for duration of study.	Drug	Stage 2: PF-04217329 - High Dose + Latanoprost 0.005%
Latanoprost 0.005%1 drop of latanoprost 0.005%, once a day, per dosed eye for duration of study.	Drug	Stage 2: PF-04217329 - Vehicle + Latanoprost 0.005%
PF-04217329 - VehicleFive minutes after latanoprost 0.005%, 1 drop of PF-04217329 vehicle, once a day, per dosed eye for duration of study.	Drug	Stage 2: PF-04217329 - Vehicle + Latanoprost 0.005%

Primary outcome

Change From Baseline in Mean Diurnal Intra Ocular Pressure (IOP) in Study Eye at Day 14: Stage I
Time frame: Stage I: Baseline, Day 14
Diurnal IOP was defined as the mean IOP over 24 hours. IOP was measured using Goldmann applanation tonometer. IOP was measured in both the eyes, and the eye with higher IOP reading at the 2 eligibility visits was referred as 'study eye' for efficacy assessment. If both the measurements were equal, right eye was selected as the study eye. IOP was measured twice in the same eye, and if the difference between 2 measurements was less than or equal to 2 millimeter of mercury (mmHg), the mean of the 2 readings was recorded as the IOP at that time point. If the difference between 2 readings was greater than 2 mmHg, a third consecutive reading was taken and the median IOP was recorded as the IOP at that time point. Mean IOP was reported as the average of individual participants' mean or median IOP values. Change from baseline = diurnal IOP at baseline - diurnal IOP at Day 14.
Change From Baseline in Mean Diurnal Intra Ocular Pressure (IOP) in Study Eye at Day 28: Stage II
Time frame: Stage II: Baseline, Day 28
Diurnal IOP was defined as the mean IOP over 24 hours. IOP was measured using Goldmann applanation tonometer. IOP was measured in both the eyes, and the eye with higher IOP reading at the 2 eligibility visits was referred as 'study eye' for efficacy assessment. If both the measurements were equal, right eye was selected as the study eye. IOP was measured twice in the same eye, and if the difference between 2 measurements was less than or equal to 2 mmHg, the mean of the 2 readings was recorded as the IOP at that time point. If the difference between 2 readings was greater than 2 mmHg, a third consecutive reading was taken and the median IOP was recorded as the IOP at that time point. Mean IOP was reported as the average of individual participants' mean or median IOP values. Change from baseline = diurnal IOP at baseline - diurnal IOP at Day 28.
Number of Participants With Treatment Emergent Ocular Adverse Events (AEs): Stage I
Time frame: Stage I: Day 1 up to 28 days after last dose of study medication (up to 44 days)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study medication and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Ocular AEs were the events which were localized in the ocular region.
Number of Participants With Treatment Emergent Ocular Adverse Events (AEs): Stage II
Time frame: Stage II: Day 1 up to 28 days after last dose of study medication (up to 59 days)
An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study medication and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Ocular AEs were the events which were localized in the ocular region.

6 secondary outcomes

Mean Intra Ocular Pressure (IOP) in Study Eye: Stage I
Time frame: Stage I: 8 ante meridiem (AM) on Day 1, 8 AM, 10 AM, 1 post meridiem (PM), 4 PM on Day 7, and 14
Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I
Time frame: Stage I: 8 AM, 10 AM, 1 PM, 4 PM on Day 0 (Baseline), 8 AM on Day 1, 8 AM, 10 AM, 1 PM, 4 PM on Day 7, and 14
Mean Intra Ocular Pressure (IOP) in Study Eye: Stage II
Time frame: Stage II: 8 AM on Day 1; 8 AM, 10 AM, 1 PM, 4 PM on Days 7, 14, and 28
Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II
Time frame: Stage II: 8 AM, 10 AM, 1 PM, and 4 PM on Day 0 (Baseline), 8 AM on Day 1; 8 AM, 10 AM, 1 PM, 4 PM on Days 7, 14, and 28
Percentage of Participants Reaching and Maintaining Target Intra Ocular Pressure (IOP): Stage I
Time frame: Stage I: Day 1 up to Day 14
Percentage of Participants Reaching and Maintaining Target Intra Ocular Pressure (IOP): Stage II
Time frame: Stage II: Day 1 up to Day 28

Results and safety

Results posted to the registry on 30 Apr 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Taprenepag 0.0025% (Stage I)	9	9
Taprenepag 0.005% (Stage I)	9	9
Taprenepag 0.01% (Stage I)	9	9
Taprenepag 0.015% (Stage I)	10	10
Taprenepag 0.02% (Stage I)	9	8
Taprenepag 0.03% (Stage I)	9	6
Taprenepag Vehicle (Stage I)	12	12
Latanoprost Vehicle and Taprenepag 0.005% (Stage II)	0	0
Latanoprost Vehicle and Taprenepag 0.01% (Stage II)	0	0
Latanoprost Vehicle and Taprenepag 0.015% (Stage II)	0	0
Latanoprost 0.005% and Taprenepag 0.005% (Stage II)	0	0
Latanoprost 0.005% and Taprenepag 0.01% (Stage II)	0	0
Latanoprost 0.005% and Taprenepag 0.015% (Stage II)	0	0
Latanoprost 0.005% and Taprenepag Vehicle (Stage II)	0	0

Primary outcome: Change From Baseline in Mean Diurnal Intra Ocular Pressure (IOP) in Study Eye at Day 14: Stage I

Time frame: Stage I: Baseline, Day 14. Mean (Standard Deviation). Unit: mmHg

Measure	Taprenepag 0.0025% (Stage I) n = 9	Taprenepag 0.005% (Stage I) n = 9	Taprenepag 0.01% (Stage I) n = 9	Taprenepag 0.015% (Stage I) n = 10	Taprenepag 0.02% (Stage I) n = 9	Taprenepag 0.03% (Stage I) n = 9	Taprenepag Vehicle (Stage I) n = 12
Baseline	25.97 (2.420)	26.25 (2.400)	25.90 (2.094)	26.44 (1.560)	28.10 (3.102)	26.26 (1.831)	26.04 (2.182)
Change at Day 14	3.65 (1.749)	5.40 (2.508)	7.18 (2.749)	6.48 (4.278)	6.00 (2.748)	6.69 (4.563)	0.64 (1.382)

Taprenepag 0.0025% (Stage I) vs Taprenepag Vehicle (Stage I): Least squares (LS) mean difference: 3.02 (90% CI 0.78 to 5.25), p = 0.028, ANCOVA
Taprenepag 0.005% (Stage I) vs Taprenepag Vehicle (Stage I): LS mean difference: 4.73 (90% CI 2.50 to 6.96), p <0.001, ANCOVA
Taprenepag 0.01% (Stage I) vs Taprenepag Vehicle (Stage I): LS mean difference: 6.56 (90% CI 4.33 to 8.79), p <0.001, ANCOVA

Population analysed: ITT population included all randomized participants who received at least 1 dose of study medication. Last observation carried forward (LOCF) method was used to impute missing values.

Primary outcome: Change From Baseline in Mean Diurnal Intra Ocular Pressure (IOP) in Study Eye at Day 28: Stage II

Time frame: Stage II: Baseline, Day 28. Mean (Standard Deviation). Unit: mmHg

Measure	Latanoprost Vehicle and Taprenepag 0.005% (Stage II) n = 35	Latanoprost Vehicle and Taprenepag 0.01% (Stage II) n = 36	Latanoprost Vehicle and Taprenepag 0.015% (Stage II) n = 36	Latanoprost 0.005% and Taprenepag 0.005% (Stage II) n = 36	Latanoprost 0.005% and Taprenepag 0.01% (Stage II) n = 36	Latanoprost 0.005% and Taprenepag 0.015% (Stage II) n = 36	Latanoprost 0.005% and Taprenepag Vehicle (Stage II) n = 35
Baseline	25.75 (2.266)	26.47 (2.563)	26.69 (2.509)	26.98 (2.813)	26.36 (2.524)	27.34 (2.876)	26.81 (2.783)
Change at Day 28	7.35 (3.559)	7.05 (2.875)	7.14 (3.462)	8.29 (3.817)	9.10 (3.292)	8.78 (3.592)	6.74 (2.927)

Latanoprost Vehicle and Taprenepag 0.005% (Stage II) vs Latanoprost 0.005% and Taprenepag Vehicle (Stage II): LS mean difference: 1.06 (90% CI -0.21 to 2.32), p = 0.171, ANCOVA
Latanoprost Vehicle and Taprenepag 0.01% (Stage II) vs Latanoprost 0.005% and Taprenepag Vehicle (Stage II): LS mean difference: 0.45 (90% CI -0.80 to 1.70), p = 0.553, ANCOVA
Latanoprost Vehicle and Taprenepag 0.015% (Stage II) vs Latanoprost 0.005% and Taprenepag Vehicle (Stage II): LS mean difference: 0.45 (90% CI -0.80 to 1.70), p = 0.555, ANCOVA

Population analysed: ITT population included all randomized participants who received at least 1 dose of study medication. LOCF method was used to impute missing values.

Primary outcome: Number of Participants With Treatment Emergent Ocular Adverse Events (AEs): Stage I

Time frame: Stage I: Day 1 up to 28 days after last dose of study medication (up to 44 days). Count of participants. Unit: Participants

Measure	Taprenepag 0.0025% (Stage I) n = 9	Taprenepag 0.005% (Stage I) n = 9	Taprenepag 0.01% (Stage I) n = 9	Taprenepag 0.015% (Stage I) n = 10	Taprenepag 0.02% (Stage I) n = 9	Taprenepag 0.03% (Stage I) n = 9	Taprenepag Vehicle (Stage I) n = 12
Value	1	2	0	5	4	9	3

Population analysed: ITT population included all randomized participants who received at least 1 dose of study medication.

Primary outcome: Number of Participants With Treatment Emergent Ocular Adverse Events (AEs): Stage II

Time frame: Stage II: Day 1 up to 28 days after last dose of study medication (up to 59 days). Count of participants. Unit: Participants

Measure	Latanoprost Vehicle and Taprenepag 0.005% (Stage II) n = 35	Latanoprost Vehicle and Taprenepag 0.01% (Stage II) n = 36	Latanoprost Vehicle and Taprenepag 0.015% (Stage II) n = 36	Latanoprost 0.005% and Taprenepag 0.005% (Stage II) n = 36	Latanoprost 0.005% and Taprenepag 0.01% (Stage II) n = 36	Latanoprost 0.005% and Taprenepag 0.015% (Stage II) n = 36	Latanoprost 0.005% and Taprenepag Vehicle (Stage II) n = 35
Value	17	20	27	24	26	26	14

Population analysed: ITT population included all randomized participants who received at least 1 dose of study medication.

6 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Taprenepag 0.0025% (Stage I)	0 of 9 (0%)	3 of 9 (33.3%)	Not reported
Taprenepag 0.005% (Stage I)	0 of 9 (0%)	3 of 9 (33.3%)	Not reported
Taprenepag 0.01% (Stage I)	0 of 9 (0%)	0 of 9 (0%)	Not reported
Taprenepag 0.015% (Stage I)	0 of 10 (0%)	5 of 10 (50%)	Not reported
Taprenepag 0.02% (Stage I)	0 of 9 (0%)	5 of 9 (55.6%)	Not reported
Taprenepag 0.03% (Stage I)	0 of 9 (0%)	9 of 9 (100%)	Not reported
Taprenepag Vehicle (Stage I)	0 of 12 (0%)	4 of 12 (33.3%)	Not reported
Latanoprost Vehicle and Taprenepag 0.005% (Stage II)	0 of 35 (0%)	18 of 35 (51.4%)	Not reported
Latanoprost Vehicle and Taprenepag 0.01% (Stage II)	1 of 36 (2.8%)	20 of 36 (55.6%)	Not reported
Latanoprost Vehicle and Taprenepag 0.015% (Stage II)	2 of 36 (5.6%)	27 of 36 (75%)	Not reported
Latanoprost 0.005% and Taprenepag 0.005% (Stage II)	0 of 36 (0%)	24 of 36 (66.7%)	Not reported
Latanoprost 0.005% and Taprenepag 0.01% (Stage II)	0 of 36 (0%)	27 of 36 (75%)	Not reported
Latanoprost 0.005% and Taprenepag 0.015% (Stage II)	0 of 36 (0%)	26 of 36 (72.2%)	Not reported
Latanoprost 0.005% and Taprenepag Vehicle (Stage II)	0 of 35 (0%)	15 of 35 (42.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 21851167Schachar RA, Raber S, Courtney R, Zhang M. A phase 2, randomized, dose-response trial of taprenepag isopropyl (PF-04217329) versus latanoprost 0.005% in open-angle glaucoma and ocular hypertension. Curr Eye Res. 2011 Sep;36(9):809-17. doi: 10.3109/02713683.2011.593725.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

23 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Mean Diurnal Intra Ocular Pressure (IOP) in Study Eye at Day 14: Stage I (time frame: Stage I: Baseline, Day 14). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00572455, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2021; AzTrials last refreshed its copy on 8 Nov 2026.