Primary Open Angle GlaucomaPhase 2NCT00595101

A Phase 2, Dose Finding Study of PF-03187207 in Patients With Primary Open Angle Glaucoma or Ocular Hypertension.

A Phase 2 study testing PF-03187207 and Latanoprost 0.005% in people with Primary Open Angle Glaucoma and Ocular Hypertension, run by Bausch & Lomb Incorporated at 13 sites in Japan.

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 investigate dose response, safety and efficacy of PF-03187207 in patients with primary open-angle glaucoma or ocular hypertension Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Primary Open Angle Glaucoma, Ocular Hypertension
What is being tested?: PF-03187207 and Latanoprost 0.005%
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 117 participants
Where: 13 sitesJapan
Study dates: Dec 2007to Jun 2008
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 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Man or woman at least 20 years of age
Diagnosis of primary open-angle glaucoma or ocular hypertension in one or both eyes.

Who cannot join

Closed/barely open anterior chamber angle or a history of acute angle closure in either eye
Contraindications to latanoprost and nitric oxide treatment
Known latanoprost non-responders

Trial locations and contacts

13 sites in 1 country.

City, postcode or hospital

13 sites in 1 country

Japan13 sites

Pfizer Investigational Site
Fuji, Shizuoka
Pfizer Investigational Site
Hachiōji, Tokyo
Pfizer Investigational Site
Hamura, Tokyo
Pfizer Investigational Site
Kasukabe, Saitama
Pfizer Investigational Site
Kawasaki, Kanagawa
Pfizer Investigational Site
Minato, Tokyo
Pfizer Investigational Site
Mishima, Shizuoka
Pfizer Investigational Site
Musashino, Tokyo
Pfizer Investigational Site
Narashino, Chiba
Pfizer Investigational Site
Setagaya City, Tokyo
Pfizer Investigational Site
Shimachi, Chiba
Pfizer Investigational Site
Shizuoka
Pfizer Investigational Site
Susono, Shizuoka

Other trials in Japan

About this study

Official title: A Phase 2, 28-Day Parallel-Group, Double-Masked, Dose Finding Study Comparing The Safety And Efficacy Of PF-03187207 To Latanoprost In Patients With Primary Open Angle Glaucoma Or Ocular Hypertension.

To investigate dose response, safety and efficacy of PF-03187207 in patients with primary open-angle glaucoma or ocular hypertension

Conditions: Primary Open Angle Glaucoma, Ocular Hypertension
Being tested: PF-03187207, Latanoprost 0.005%, PF-03187207 Vehicle, Latanoprost Vehicle
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-03187207Drug
Latanoprost 0.005%Drug
PF-03187207 VehicleDrug
One drop in study eye once daily for the first 28 days to all subjects, followed by 28 days in combination with PF-03187207.
Latanoprost VehicleDrug

Study groups in NCT00595101
Study group	Role	What they receive
PF-03187207 High Dose and Latanoprost Vehicle	Experimental	A single drop of each, once daily in study eye for 28 days Receives: Drug: PF-03187207; Drug: Latanoprost Vehicle
Latanoprost 0.005% and PF-03187207 Vehicle	Experimental	A single drop of each, once daily in study eye for 28 days Receives: Drug: Latanoprost 0.005%; Drug: PF-03187207 Vehicle
PF-03187207 Medium Dose and Latanoprost Vehicle	Experimental	A single drop of each, once daily in study eye for 28 days Receives: Drug: PF-03187207; Drug: Latanoprost Vehicle
PF-03187207 Low Dose and Latanoprost Vehicle	Experimental	A single drop of each, once daily in study eye for 28 days Receives: Drug: PF-03187207; Drug: Latanoprost Vehicle

What is being measured

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

Change From Baseline Mean Diurnal Intraocular Pressure (IOP) in the Study Eye on Day 28
Intraocular pressure (IOP) was measured using a Goldmann applanation tonometer. Diurnal IOP, defined as the mean IOP over the day based on values obtained at 8 AM, 10 AM, 1 PM, and 4 PM, was calculated for each visit. Both eyes were tested, with the right eye preceding the left eye. The operator initially set the dial at 10 mmHg, then looked through the slit lamp and adjusted the dial to take the reading, and then recorded the results. The procedure was repeated on the same eye twice consecutively. If the measurements were within 2 mmHg or less of each other, the mean of the 2 readings was recorded as the IOP at that time point. If the 2 readings were more than 2 mmHg of each other, a third (consecutive) reading was taken and the median (middle) IOP was recorded as the IOP at that time point.
Measured: Baseline, 28 days

Secondary outcomes (2)

Change From Baseline in Mean Intraocular Pressure (IOP) at Specific Time Points on Day 14 and Day 28
Intraocular pressure (IOP) was measured using a Goldmann applanation tonometer. Both eyes were tested, with the right eye preceding the left eye. The operator initially set the dial at 10 mmHg, then looked through the slit lamp and adjusted the dial to take the reading, and then recorded the results. The procedure was repeated on the same eye twice consecutively. If the measurements were within 2 mmHg or less of each other, the mean of the 2 readings was recorded as the IOP at that time point. If the 2 readings were more than 2 mmHg of each other, a third (consecutive) reading was taken and the median (middle) IOP was recorded as the IOP at that time point.
Measured: Baseline, Day 14, Day 28
Target IOP
Percentage of participants with IOP of 18 mmHg or Lower, 16 mmHg or Lower, or 14 mmHg or Lower at Any Visit Through Day 28. Intraocular pressure (IOP) was measured using a Goldmann applanation tonometer. Both eyes were tested, with the right eye preceding the left eye. The operator initially set the dial at 10 mmHg, then looked through the slit lamp and adjusted the dial to take the reading, and then recorded the results. The procedure was repeated on the same eye twice consecutively. If the measurements were within 2 mmHg or less of each other, the mean of the 2 readings was recorded as the IOP at that time point. If the 2 readings were more than 2 mmHg of each other, a third (consecutive) reading was taken and the median (middle) IOP was recorded as the IOP at that time point.
Measured: Up to 28 days

Timeline

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

Dec 2007Jun 2008

First posted16 Jan 2008 (estimated)
Study startDec 2007
Primary completionJun 2008
Study completionJun 2008

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.
Other trials for Primary Open Angle GlaucomaStudies of the same condition, open and under way.
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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 117 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00595101
Sponsor's protocol ID: A9441003
Status last verified: Sep 2020
First submitted: 4 Jan 2008
Last updated: 14 Sep 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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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Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
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PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
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All Primary Open Angle Glaucoma trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, 28-Day Parallel-Group, Double-Masked, Dose Finding Study Comparing The Safety And Efficacy Of PF-03187207 To Latanoprost In Patients With Primary Open Angle Glaucoma Or Ocular Hypertension.
ClinicalTrials.gov ID: NCT00595101
Acronym / sponsor ID: A9441003
Conditions: Primary Open Angle Glaucoma, Ocular Hypertension
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 117 participants (actual)
Lead sponsor: Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
Study start: Dec 2007
Primary completion: Jun 2008 (actual)
Study completion: Jun 2008 (actual)
First posted: 16 Jan 2008 (estimated)
Results: Posted 27 Aug 2020

Clinical summary

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

To investigate dose response, safety and efficacy of PF-03187207 in patients with primary open-angle glaucoma or ocular hypertension

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
PF-03187207 High Dose and Latanoprost Vehicle	Experimental	Drug: PF-03187207, Drug: Latanoprost VehicleA single drop of each, once daily in study eye for 28 days
Latanoprost 0.005% and PF-03187207 Vehicle	Experimental	Drug: Latanoprost 0.005%, Drug: PF-03187207 VehicleA single drop of each, once daily in study eye for 28 days
PF-03187207 Medium Dose and Latanoprost Vehicle	Experimental	Drug: PF-03187207, Drug: Latanoprost VehicleA single drop of each, once daily in study eye for 28 days
PF-03187207 Low Dose and Latanoprost Vehicle	Experimental	Drug: PF-03187207, Drug: Latanoprost VehicleA single drop of each, once daily in study eye for 28 days

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Man or woman at least 20 years of age
Diagnosis of primary open-angle glaucoma or ocular hypertension in one or both eyes.

Key exclusion criteria (3 listed)

Closed/barely open anterior chamber angle or a history of acute angle closure in either eye
Contraindications to latanoprost and nitric oxide treatment
Known latanoprost non-responders

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-03187207	Drug	PF-03187207 High Dose and Latanoprost Vehicle, PF-03187207 Low Dose and Latanoprost Vehicle, PF-03187207 Medium Dose and Latanoprost Vehicle
Latanoprost 0.005%	Drug	Latanoprost 0.005% and PF-03187207 Vehicle
PF-03187207 VehicleOne drop in study eye once daily for the first 28 days to all subjects, followed by 28 days in combination with PF-03187207.	Drug	Latanoprost 0.005% and PF-03187207 Vehicle
Latanoprost Vehicle	Drug	PF-03187207 High Dose and Latanoprost Vehicle, PF-03187207 Low Dose and Latanoprost Vehicle, PF-03187207 Medium Dose and Latanoprost Vehicle

Primary outcome

Change From Baseline Mean Diurnal Intraocular Pressure (IOP) in the Study Eye on Day 28
Time frame: Baseline, 28 days
Intraocular pressure (IOP) was measured using a Goldmann applanation tonometer. Diurnal IOP, defined as the mean IOP over the day based on values obtained at 8 AM, 10 AM, 1 PM, and 4 PM, was calculated for each visit. Both eyes were tested, with the right eye preceding the left eye. The operator initially set the dial at 10 mmHg, then looked through the slit lamp and adjusted the dial to take the reading, and then recorded the results. The procedure was repeated on the same eye twice consecutively. If the measurements were within 2 mmHg or less of each other, the mean of the 2 readings was recorded as the IOP at that time point. If the 2 readings were more than 2 mmHg of each other, a third (consecutive) reading was taken and the median (middle) IOP was recorded as the IOP at that time point.

2 secondary outcomes

Change From Baseline in Mean Intraocular Pressure (IOP) at Specific Time Points on Day 14 and Day 28
Time frame: Baseline, Day 14, Day 28
Target IOP
Time frame: Up to 28 days

Results and safety

Results posted to the registry on 27 Aug 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PF-0318 0.006%	29	29
PF-0318 0.024%	29	28
PF-0318 0.04%	29	29
0.005% Latanoprost	30	30

Primary outcome: Change From Baseline Mean Diurnal Intraocular Pressure (IOP) in the Study Eye on Day 28

Time frame: Baseline, 28 days. Mean (Standard Deviation). Unit: mmHg (milimeters of mercury)

Measure	PF-0318 0.006% n = 28	PF-0318 0.024% n = 27	PF-0318 0.04% n = 27	0.005% Latanoprost n = 30
Value	-5.12 (2.55)	-5.94 (3.09)	-5.02 (2.03)	-5.25 (2.53)

Population analysed: The Per Protocol (PP) population consisted of all subjects in the intention to treat (ITT) population excluding those who made major protocol violations before completing the study. The PP population was considered as the primary analysis population of efficacy (primary and secondary endpoints) of the study.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 28 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PF-0318 0.006%	0 of 29 (0%)	2 of 29 (6.9%)	Not reported
PF-0318 0.024%	0 of 29 (0%)	3 of 29 (10.3%)	Not reported
PF-0318 0.04%	0 of 29 (0%)	5 of 29 (17.2%)	Not reported
0.005% Latanoprost	0 of 30 (0%)	2 of 30 (6.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Primary Open Angle Glaucoma

RecruitingPhase 2
A Phase 2a Study Comparing the Efficacy, Safety and Tolerability of Pregabalin Eye Drops Comparing With Timolol Eye Drops in Adults With Glaucoma or High Eye Pressure.
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Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
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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.

Ken Harper study director

Bausch & Lomb Incorporated

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PF-03187207 and Latanoprost 0.005% in people with Primary Open Angle Glaucoma and Ocular Hypertension, run by Bausch & Lomb Incorporated at 13 sites in Japan.

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 3 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 14 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Japan. 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 27 Aug 2020). 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 Mean Diurnal Intraocular Pressure (IOP) in the Study Eye on Day 28 (time frame: Baseline, 28 days). 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 NCT00595101.

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 14 Sep 2020.