Ocular HypertensionPhase 3NCT00800267
A Study of Glaucoma or Ocular Hypertension in Patients Within the United States
A Phase 3 study testing latanoprost 0.005%, fixed combination latanoprost-timolol and timolol 0.5% in people with Ocular Hypertension and Glaucoma, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 53 sites in United States.
Trial summary
Safety and efficacy study comparing between fixed combination latanoprost-timolol and its component parts. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ocular Hypertension, Glaucoma
- What is being tested?
- latanoprost 0.005%, fixed combination latanoprost-timolol and timolol 0.5%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 418 participants
- Where
- 53 sitesUnited States
- Study dates
- Jul 1997to Jun 1999
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Unilateral or bilateral primary open angle glaucoma, capsular glaucoma, pigmentary glaucoma or ocular hypertension.
- Patients currently on IOP reducing therapy: IOP greater than or equal to 25mmHg (Ltwo IOP determinations at pre-study separated by at least one hour) OR Patients without IOP reducing therapy: IOP greater than or equal to 30mmHg (two IOP determinations at pre-study separated by at least one hour).
Who cannot join
- History of acute angle closure or closed/barely open anterior chamber angle.
- Current use of contact lenses.
- Ocular surgery or argon laser trabeculoplasty (ALT) within three months prior to pre-study visit.
- Ocular inflammation/infection occurring within three months prior to pre-study visit.
- Hypersensitivity to benzalkonium chloride or to any other component of the study drug solutions.
- Other abnormal ocular condition or symptom preventing the patient from entering the study, according to the investigator's judgement.
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- Patients with conditions in which treatment with B-blocking agents are contraindicated: cardiac failure, sinus bradycardia, second and third degree atrio-ventricular block.
- Patients with conditions in which treatment with B-blocking agents are contraindicated: bronchial asthma, history of bronchial asthma or chronic obstructive pulmonary disease.
- Inability to adhere to treatment/visit plan.
- Have participated in any other clinical study within one month prior to pre-study visit.
Trial locations and contacts
53 sites in 1 country.
53 sites in 1 country
United States53 sites
Pfizer Investigational Site
Anaheim, California, 92801
Pfizer Investigational Site
Anaheim, California, 92807
Pfizer Investigational Site
Atlanta, Georgia, 30322
Pfizer Investigational Site
Atlanta, Georgia, 30342
Pfizer Investigational Site
Atlanta, Georgia, 30349
Pfizer Investigational Site
Austin, Texas, 78731-4941
Pfizer Investigational Site
Baltimore, Maryland, 21201
Pfizer Investigational Site
Boston, Massachusetts, 02111
Pfizer Investigational Site
Boulder, Colorado, 80304-3573
Pfizer Investigational Site
Charleston, South Carolina, 29412
Pfizer Investigational Site
Charlotte, North Carolina, 28204
Pfizer Investigational Site
Charlotte, North Carolina, 28210
Pfizer Investigational Site
Charlotte, North Carolina, 28260
Pfizer Investigational Site
Charlottesville, Virginia
Pfizer Investigational Site
Chicago, Illinois, 60612
Pfizer Investigational Site
Concord, New Hampshire, 03301
Pfizer Investigational Site
Denver, Colorado, 80210
Pfizer Investigational Site
East Point, Georgia, 30223
Pfizer Investigational Site
Elkhart, Indiana, 46515
Pfizer Investigational Site
Galveston, Texas, 77555-1141
Pfizer Investigational Site
Golden Valley, Minnesota, 55422
Pfizer Investigational Site
Griffin, Georgia, 30223
Pfizer Investigational Site
Houston, Texas, 77030
Pfizer Investigational Site
Iowa City, Iowa, 52245
Pfizer Investigational Site
Kansas City, Missouri, 64111
Pfizer Investigational Site
Kansas City, Missouri, 64114
Pfizer Investigational Site
Largo, Florida, 34640
Pfizer Investigational Site
Louisville, Kentucky, 40207
Pfizer Investigational Site
Madison, Wisconsin, 53705
Pfizer Investigational Site
Madison, Wisconsin, 53715
Pfizer Investigational Site
Matthews, North Carolina, 28105
Pfizer Investigational Site
Memphis, Tennessee, 38119
Pfizer Investigational Site
Minneapolis, Minnesota, 55421
Pfizer Investigational Site
Mishawaka, Indiana, 46545
Pfizer Investigational Site
Monroe, North Carolina, 28112
Pfizer Investigational Site
Morrow, Georgia, 30260
Pfizer Investigational Site
Mt. Pleasant, South Carolina, 29464-3245
Pfizer Investigational Site
Owings Mills, Maryland, 21117
Pfizer Investigational Site
Portland, Oregon, 97201
Pfizer Investigational Site
Portland, Oregon, 97210
Pfizer Investigational Site
Richmond, Virginia, 23219
Pfizer Investigational Site
Richmond, Virginia, 23235
Pfizer Investigational Site
Sacramento, California, 95819
Pfizer Investigational Site
Sacramento, California, 95823
Pfizer Investigational Site
San Francisco, California, 94115
Pfizer Investigational Site
South Bend, Indiana, 46601
Pfizer Investigational Site
South Bend, Indiana, 46617
Pfizer Investigational Site
South Plainfield, New Jersey, 07080
Pfizer Investigational Site
Tacoma, Washington, 98431
Pfizer Investigational Site
Tampa, Florida, 33613
Pfizer Investigational Site
Warrensburg, Missouri, 64093
Pfizer Investigational Site
Wheaton, Illinois, 60187
Pfizer Investigational Site
Wyomissing, Pennsylvania, 19610
About this study
Official title: A 6-month, Randomized, Double-masked Comparison of Fixed Combination of Latanoprost and Timolol With the Individual Components, Continuing Into a 6-month Open Label Safety Study of Fixed Combination in Patients With Glaucoma or Ocular Hypertension. A Multicenter Study in the United States
Safety and efficacy study comparing between fixed combination latanoprost-timolol and its component parts.
- Conditions
- Ocular Hypertension, Glaucoma
- Being tested
- latanoprost 0.005%, fixed combination latanoprost-timolol, timolol 0.5%
- Keywords
- glaucoma, ocular hypertension, Fixed combination latanoprost-timolol, latanoprost, timolol
- Medical subject headings
- Ocular Hypertension, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
latanoprost 0.005%Drug
placebo in the morning and latanoprost .005% in the evening
fixed combination latanoprost-timololDrug
one drop in the morning and placebo in the evening
timolol 0.5%Drug
one drop in the morning and evening
| Study group | Role | What they receive |
|---|---|---|
| Fixed combination of latanoprost 0.005% and timolol 0.5% | Experimental | Not described Receives: Drug: fixed combination latanoprost-timolol |
| latanoprost 0.005% | Active comparator | Not described Receives: Drug: latanoprost 0.005% |
| Timolol - 0.5% | Active comparator | Not described Receives: Drug: timolol 0.5% |
What is being measured
The primary outcome is the main question the study is designed to answer.
The differences from baseline in diurnal IOP reduction after six months of treatment will be tested between the fixed combination and the monotherapy groups.
Measured: 6 months
Primary objective: to demonstrate that the fixed combination of latanoprost and timolol has a better IOP-reducing effect than the individual monotherapies.
Measured: 6 months
Secondary outcomes (7)
To examine, within treatment groups, the diurnal IOP reducing effect from baseline for all effect from baseline between the monotherapies latanoprost and timolol
Measured: 6 months
To compare the diurnal IOP reducing effect from baseline between the monotherapies latanoprost and timolol at Week 26
Measured: 6 months
To compared the number of treatment failures and patients withdrawn due to uncontrolled IOP from baseline to Week 26 between treatment groups
Measured: 6 months
To describe the IOP development from baseline to Week 26 for all treatment groups
Measured: 6 months
To compared the IOP reducing effect from baseline to Week 26 of the monotherapies with the IOP reducing effect from Week 26 to Week 52 of the fixed combination
Measured: 6 months
To examine, within the fixed combination treatment group, the diurnal IOP reducing effect from baseline to Week 26 and Week 52
Measured: 6 months
To follow the safety variables throughout the study periods.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2008 (estimated)
- Study startJul 1997
- Primary completionJun 1999
- Study completionJun 1999
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ocular HypertensionStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 418 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
- NCT00800267
- Sponsor's protocol ID
- 96TIPG005
- Other IDs
- A6641006
- Status last verified
- Mar 2009
- First submitted
- 3 Nov 2008
- Last updated
- 18 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 6-month, Randomized, Double-masked Comparison of Fixed Combination of Latanoprost and Timolol With the Individual Components, Continuing Into a 6-month Open Label Safety Study of Fixed Combination in Patients With Glaucoma or Ocular Hypertension. A Multicenter Study in the United States
- ClinicalTrials.gov ID
- NCT00800267
- Acronym / sponsor ID
- 96TIPG005
- Conditions
- Ocular Hypertension, Glaucoma
- Keywords
- glaucoma, ocular hypertension, Fixed combination latanoprost-timolol, latanoprost, timolol
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 418 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 1997
- Primary completion
- Jun 1999 (actual)
- Study completion
- Jun 1999 (actual)
- First posted
- 2 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Safety and efficacy study comparing between fixed combination latanoprost-timolol and its component parts.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fixed combination of latanoprost 0.005% and timolol 0.5% | Experimental | Drug: fixed combination latanoprost-timolol |
| latanoprost 0.005% | Active comparator | Drug: latanoprost 0.005% |
| Timolol - 0.5% | Active comparator | Drug: timolol 0.5% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Unilateral or bilateral primary open angle glaucoma, capsular glaucoma, pigmentary glaucoma or ocular hypertension.
- Patients currently on IOP reducing therapy: IOP greater than or equal to 25mmHg (Ltwo IOP determinations at pre-study separated by at least one hour) OR Patients without IOP reducing therapy: IOP greater than or equal to 30mmHg (two IOP determinations at pre-study separated by at least one hour).
Key exclusion criteria (10 listed)
- History of acute angle closure or closed/barely open anterior chamber angle.
- Current use of contact lenses.
- Ocular surgery or argon laser trabeculoplasty (ALT) within three months prior to pre-study visit.
- Ocular inflammation/infection occurring within three months prior to pre-study visit.
- Hypersensitivity to benzalkonium chloride or to any other component of the study drug solutions.
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 |
|---|---|---|
| latanoprost 0.005%placebo in the morning and latanoprost .005% in the evening | Drug | latanoprost 0.005% |
| fixed combination latanoprost-timololone drop in the morning and placebo in the evening | Drug | Fixed combination of latanoprost 0.005% and timolol 0.5% |
| timolol 0.5%one drop in the morning and evening | Drug | Timolol - 0.5% |
Primary outcome
The differences from baseline in diurnal IOP reduction after six months of treatment will be tested between the fixed combination and the monotherapy groups.
Time frame: 6 months
Primary objective: to demonstrate that the fixed combination of latanoprost and timolol has a better IOP-reducing effect than the individual monotherapies.
Time frame: 6 months
7 secondary outcomes
To examine, within treatment groups, the diurnal IOP reducing effect from baseline for all effect from baseline between the monotherapies latanoprost and timolol
Time frame: 6 months
To compare the diurnal IOP reducing effect from baseline between the monotherapies latanoprost and timolol at Week 26
Time frame: 6 months
To compared the number of treatment failures and patients withdrawn due to uncontrolled IOP from baseline to Week 26 between treatment groups
Time frame: 6 months
To describe the IOP development from baseline to Week 26 for all treatment groups
Time frame: 6 months
To compared the IOP reducing effect from baseline to Week 26 of the monotherapies with the IOP reducing effect from Week 26 to Week 52 of the fixed combination
Time frame: 6 months
To examine, within the fixed combination treatment group, the diurnal IOP reducing effect from baseline to Week 26 and Week 52
Time frame: 6 months
To follow the safety variables throughout the study periods.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
- 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
53 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing latanoprost 0.005%, fixed combination latanoprost-timolol and timolol 0.5% in people with Ocular Hypertension and Glaucoma, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 53 sites in United States.
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 10 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 18 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 53 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The differences from baseline in diurnal IOP reduction after six months of treatment will be tested between the fixed combination and the monotherapy groups. (time frame: 6 months). The study lists 2 primary outcomes in all. 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 18 Feb 2021.