GlaucomaPhase 3NCT00716859
A Phase 3 Prospective, Randomized, Double-Masked, 12-Week, Parallel Group Study In Pediatric Subjects With Glaucoma.
A Phase 3 study testing Timolol and latanoprost in people with Glaucoma, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 48 sites in 20 countries.
Trial summary
To assess the effectiveness of latanoprost 0.005% ophthalmic solution dosed once-daily and timolol 0.5% dosed twice-daily in paediatric subjects of 18 years of age or under who are diagnosed with glaucoma. Read more about this study
- Who is it for?
- Ages 36 weeks to 18 years
- Conditions the study is for
- Glaucoma
- What is being tested?
- Timolol and latanoprost
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 139 participants
- Where
- 48 sitesin 20 countries
- Study dates
- Jul 2008to Nov 2009
- Phase
- Phase 3
- 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 36 weeks to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Male or female of 18 years of age or under
- Diagnosis of glaucoma
- IOP of 22 mmHg or above in at least 1 eye
Who cannot join
- Require surgery for acute angle closure
- Have had prior cyclodestructive procedures
- Have a history of ocular trauma or surgery in either eye within 3 months of the baseline visit
Trial locations and contacts
48 sites in 20 countries.
48 sites in 20 countries
United States7 sites
Pfizer Investigational Site
Atlanta, Georgia, 30322
Pfizer Investigational Site
Henderson, Nevada, 89052
Pfizer Investigational Site
Henderson, Nevada, 89074
Pfizer Investigational Site
Indianapolis, Indiana, 46202
Pfizer Investigational Site
Las Vegas, Nevada, 89148
Pfizer Investigational Site
Minneapolis, Minnesota, 55455
Pfizer Investigational Site
Pembroke Pines, Florida, 33028
Portugal5 sites
Pfizer Investigational Site
Coimbra, 3000-548
Pfizer Investigational Site
Lisbon, 1169-019
Pfizer Investigational Site
Lisbon, 1169-097
Pfizer Investigational Site
Lisbon, 1649-035
Pfizer Investigational Site
Porto, 4099-001
Ukraine5 sites
Pfizer Investigational Site
Kharkiv, 61000
Pfizer Investigational Site
Kyiv, 01135
Pfizer Investigational Site
Kyiv, 04050
Pfizer Investigational Site
Kyiv
Pfizer Investigational Site
Odesa, 65061
France3 sites
Pfizer Investigational Site
Amiens, Cedex 1, 80054
Pfizer Investigational Site
Lille, 59037
Pfizer Investigational Site
Lyon, 69437
India3 sites
Pfizer Investigational Site
Ahmedabad, Gujarat, 380004
Pfizer Investigational Site
Coimbatore, Tamil Nadu, 641 014
Pfizer Investigational Site
Hyderabad, Andhra Pradesh, 500034
Poland3 sites
Pfizer Investigational Site
Bialystok, 15-274
Pfizer Investigational Site
Gdansk, 80-211
Pfizer Investigational Site
Wroclaw, 50-368
Spain3 sites
Pfizer Investigational Site
Esplugues de Llobregat, Barcelona, 08950
Pfizer Investigational Site
Madrid, 28040
Pfizer Investigational Site
Seville, 41013
Colombia2 sites
Pfizer Investigational Site
Bogota, Cundinamarca, 0000
Pfizer Investigational Site
Medellín, Antioquia, 0000
Germany2 sites
Pfizer Investigational Site
Regenstauf, 93128
Pfizer Investigational Site
Schorndorf, 73614
Italy2 sites
Pfizer Investigational Site
Catania, 95123
Pfizer Investigational Site
Milan, 20162
Philippines2 sites
Pfizer Investigational Site
Makati City, 1200
Pfizer Investigational Site
Mandaluyong, 1500
Russia2 sites
Pfizer Investigational Site
Moscow, 119331
Pfizer Investigational Site
Saint Petersburg, 194100
United Kingdom2 sites
Pfizer Investigational Site
Birmingham, B18 7QH
Pfizer Investigational Site
London, EC1V 2PD
About this study
Official title: A Phase 3 Prospective, Randomized, Double-Masked, 12-Week, Parallel Group Study Evaluating The Efficacy And Safety Of Latanoprost And Timolol In Pediatric Subjects With Glaucoma.
To assess the effectiveness of latanoprost 0.005% ophthalmic solution dosed once-daily and timolol 0.5% dosed twice-daily in paediatric subjects of 18 years of age or under who are diagnosed with glaucoma.
- Conditions
- Glaucoma
- Being tested
- Timolol, latanoprost
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TimololDrug
Timolol 0.5% dosed twice-daily
latanoprostDrug
Latanoprost 0.005% ophthalmic solution dosed once-daily
| Study group | Role | What they receive |
|---|---|---|
| Timolol | Active comparator | Not described Receives: Drug: Timolol |
| latanoprost | Experimental | Not described Receives: Drug: latanoprost |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction From Baseline in Mean IOP at Week 12, Last Observation Carried Forward (LOCF)
Calculated as Baseline IOP minus Week 12 IOP, LOCF. IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were less than or equal to (≤) 2 millimeters of mercury (mmHg) of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded.
Measured: Baseline, Week 12
Secondary outcomes (9)
Reduction From Baseline in Mean IOP at Week 1
Calculated as Baseline IOP minus Week 1 IOP (observed). IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were ≤ 2 mmHg of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded.
Measured: Baseline, Week 1
Reduction From Baseline in Mean IOP at Week 4
Calculated as Baseline IOP minus Week 4 IOP (observed). IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were ≤ 2 mmHg of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded.
Measured: Baseline, Week 4
Reduction From Baseline in Mean IOP at Week 12 (Observed)
Calculated as Baseline IOP minus Week 12 IOP (observed). IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were ≤ 2 mmHg of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded.
Measured: Baseline, Week 12
Mean IOP at Baseline
IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were ≤ 2 mmHg of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded.
Measured: Baseline
Mean IOP at Week 1
IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were ≤ 2 mmHg of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded.
Measured: Week 1
Mean IOP at Week 4
IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were ≤ 2 mmHg of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded.
Measured: Week 4
Mean IOP at Week 12
IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were ≤ 2 mmHg of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded.
Measured: Week 12
Percentage of Participants With Greater Than or Equal to (≥) 15% IOP Reduction From Baseline at Both Weeks 4 and 12
Participants with ≥15% IOP reduction from baseline at both Week 4 and Week 12. Calculated as (post baseline IOP minus baseline IOP) divided by IOP, multiplied by 100%. IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were ≤ 2 mmHg of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded.
Measured: Baseline, Week 4, and Week 12
Percentage of Participants Discontinuing Therapy Due to a Drug-related Adverse Experience
An investigator's causality assessment was the determination of whether there existed a reasonable possibility that the investigational product caused or contributed to an adverse event (AE). If the investigator did not know whether or not investigational product caused the event, then the event was handled as "related to investigational product" for reporting purposes.
Measured: Baseline through Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2008 (estimated)
- Study startJul 2008
- Primary completionNov 2009
- Study completionNov 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.
- Other trials for 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00716859
- Sponsor's protocol ID
- A6111137
- Status last verified
- Jan 2011
- First submitted
- 14 Jul 2008
- Last updated
- 3 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Prospective, Randomized, Double-Masked, 12-Week, Parallel Group Study Evaluating The Efficacy And Safety Of Latanoprost And Timolol In Pediatric Subjects With Glaucoma.
- ClinicalTrials.gov ID
- NCT00716859
- Acronym / sponsor ID
- A6111137
- Conditions
- Glaucoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 16 Jul 2008 (estimated)
- Results
- Posted 2 Dec 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the effectiveness of latanoprost 0.005% ophthalmic solution dosed once-daily and timolol 0.5% dosed twice-daily in paediatric subjects of 18 years of age or under who are diagnosed with glaucoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Timolol | Active comparator | Drug: Timolol |
| latanoprost | Experimental | Drug: latanoprost |
Who may qualify
- Ages
- 36 weeks to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Male or female of 18 years of age or under
- Diagnosis of glaucoma
- IOP of 22 mmHg or above in at least 1 eye
Key exclusion criteria (3 listed)
- Require surgery for acute angle closure
- Have had prior cyclodestructive procedures
- Have a history of ocular trauma or surgery in either eye within 3 months of the baseline visit
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 |
|---|---|---|
| TimololTimolol 0.5% dosed twice-daily | Drug | Timolol |
| latanoprostLatanoprost 0.005% ophthalmic solution dosed once-daily | Drug | latanoprost |
Primary outcome
Reduction From Baseline in Mean IOP at Week 12, Last Observation Carried Forward (LOCF)
Time frame: Baseline, Week 12
Calculated as Baseline IOP minus Week 12 IOP, LOCF. IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were less than or equal to (≤) 2 millimeters of mercury (mmHg) of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded.
9 secondary outcomes
Reduction From Baseline in Mean IOP at Week 1
Time frame: Baseline, Week 1
Reduction From Baseline in Mean IOP at Week 4
Time frame: Baseline, Week 4
Reduction From Baseline in Mean IOP at Week 12 (Observed)
Time frame: Baseline, Week 12
Mean IOP at Baseline
Time frame: Baseline
Mean IOP at Week 1
Time frame: Week 1
Mean IOP at Week 4
Time frame: Week 4
Mean IOP at Week 12
Time frame: Week 12
Percentage of Participants With Greater Than or Equal to (≥) 15% IOP Reduction From Baseline at Both Weeks 4 and 12
Time frame: Baseline, Week 4, and Week 12
Percentage of Participants Discontinuing Therapy Due to a Drug-related Adverse Experience
Time frame: Baseline through Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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
48 sites in 20 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Timolol and latanoprost in people with Glaucoma, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 48 sites in 20 countries.
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 3 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 3 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 48 sites in United States, Portugal, Ukraine, France, India and 15 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 2 Dec 2010). 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?
Reduction From Baseline in Mean IOP at Week 12, Last Observation Carried Forward (LOCF) (time frame: Baseline, Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Feb 2021.