Ocular HypertensionPhase 3NCT00856622
A Study Demonstrating The Effect Of Latanoprost In Combination With Timolol, Latanoprost Alone And Timolol Alone On Eye Pressure In Open Angle Glaucoma Or Ocular Hypertension In Patients
A Phase 3 study testing i. Fixed combination of latanoprost 0.005% and timolol 0.5%, timolol 0.5% ophthalmic solution and latanoprost 0.005% ophthalmic solution in people with Ocular Hypertension and Glaucoma, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 37 sites in Germany.
Trial summary
The purpose of this study is to demonstrate that fixed combination of latanoprost and timolol (PhXA41) has better IOP lowering effect than the individual monotherapies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ocular Hypertension, Glaucoma, Open-angle Glaucoma
- What is being tested?
- i. Fixed combination of latanoprost 0.005% and timolol 0.5%, timolol 0.5% ophthalmic solution and latanoprost 0.005% ophthalmic solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 436 participants
- Where
- 37 sitesGermany
- Study dates
- Aug 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 (two 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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- Cardiac failure, sinus bradycardia, second and third degree of atrioventricular block. (The routines for prescribing topical B-blocking agents will be followed.
- Bronchial asthma, history of bronchial asthma or chronic obstructive pulmonary disease. (The routines for prescribing topical B-blocking agents will be followed).
- Pregnancy
- Women of childbearing potential who has not used adequate contraceptive methods during the last three months.
- 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
37 sites in 1 country.
37 sites in 1 country
Germany37 sites
Pfizer Investigational Site
Aachen
Pfizer Investigational Site
Aalen
Pfizer Investigational Site
Ahaus, 48683
Pfizer Investigational Site
Alzey, 55232
Pfizer Investigational Site
Aschaffenburg, 63739
Pfizer Investigational Site
Bad Abbach, 93077
Pfizer Investigational Site
Berlin, 13088
Pfizer Investigational Site
Coesfeld, 48653
Pfizer Investigational Site
Dillingen, 89407
Pfizer Investigational Site
Eitorf, 53783
Pfizer Investigational Site
Erlangen, 91052
Pfizer Investigational Site
Essen, 45147
Pfizer Investigational Site
Freiburg im Breisgau, 79106
Pfizer Investigational Site
Freising, 85354
Pfizer Investigational Site
Fulda
Pfizer Investigational Site
Greifswald, 17489
Pfizer Investigational Site
Gummersbach, 51643
Pfizer Investigational Site
Hanover
Pfizer Investigational Site
Hirschaid, 96114
Pfizer Investigational Site
Iserlohn, 58638
Pfizer Investigational Site
Koblenz, 56068
Pfizer Investigational Site
Leonberg, 71229
Pfizer Investigational Site
Leverkusen, 51373
Pfizer Investigational Site
Mainz, 55116
Pfizer Investigational Site
Mainz, 55124
Pfizer Investigational Site
Mainz, 55131
Pfizer Investigational Site
Mülheim, 45481
Pfizer Investigational Site
München, 80336
Pfizer Investigational Site
München, 81925
Pfizer Investigational Site
Münster, 48165
Pfizer Investigational Site
Offenbach, 63065
Pfizer Investigational Site
Osnabrück, 49076
Pfizer Investigational Site
Parsberg, 92331
Pfizer Investigational Site
Siegburg, 53721
Pfizer Investigational Site
Sulzbach, 66280
Pfizer Investigational Site
Trier, 54290
Pfizer Investigational Site
Weiden, 92637
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.
The purpose of this study is to demonstrate that fixed combination of latanoprost and timolol (PhXA41) has better IOP lowering effect than the individual monotherapies.
- Conditions
- Ocular Hypertension, Glaucoma, Open-angle Glaucoma
- Being tested
- i. Fixed combination of latanoprost 0.005% and timolol 0.5%, timolol 0.5% ophthalmic solution, latanoprost 0.005% ophthalmic solution
- Keywords
- open-angle glaucoma ocular hypertension glaucoma
- Medical subject headings
- Ocular Hypertension, Glaucoma, Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
i. Fixed combination of latanoprost 0.005% and timolol 0.5%Drug
Also called xalacom, xalcom
one drop in the morning and placebo in the evening
timolol 0.5% ophthalmic solutionDrug
Also called timoptic
one drop in the morning and evening
latanoprost 0.005% ophthalmic solutionDrug
Also called xalatan
placebo in the morning and latanoprost .005% in the evening
| Study group | Role | What they receive |
|---|---|---|
| Fixed combination of latanoprost 0.005% and timolol 0.5% | Experimental | Not described Receives: Drug: i. Fixed combination of latanoprost 0.005% and timolol 0.5% |
| timolol 0.5% ophthalmic solution | Active comparator | one drop in the morning and evening Receives: Drug: timolol 0.5% ophthalmic solution |
| latanoprost 0.005% ophthalmic solution | Active comparator | placebo in the morning and latanoprost .005% in the evening Receives: Drug: latanoprost 0.005% ophthalmic solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 (8)
To examine, within treatment groups, the diurnal IOP reducing effect from baseline for all treatments at Week 26
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 compare the number of treatment failures and patients withdrawn due to uncontrolled IOP from baseline to Week 26 between treatment groups
Measured: 6 Months
To compare the proportion of patients reaching pre-specified (15, 18, and 21 mmHg) target diurnal IOPs between the treatment groups at Week 26
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 posted6 Mar 2009 (estimated)
- Study startAug 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
- 436 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
- NCT00856622
- Sponsor's protocol ID
- 96TIPG004
- Other IDs
- A6641005
- Status last verified
- Oct 2018
- First submitted
- 2 Mar 2009
- Last updated
- 21 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 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.
- ClinicalTrials.gov ID
- NCT00856622
- Acronym / sponsor ID
- 96TIPG004
- Conditions
- Ocular Hypertension, Glaucoma, Open-angle Glaucoma
- Keywords
- open-angle glaucoma ocular hypertension glaucoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 436 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 1997
- Primary completion
- Jun 1999 (actual)
- Study completion
- Jun 1999 (actual)
- First posted
- 6 Mar 2009 (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.
The purpose of this study is to demonstrate that fixed combination of latanoprost and timolol (PhXA41) has better IOP lowering effect than the individual monotherapies.
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: i. Fixed combination of latanoprost 0.005% and timolol 0.5% |
| timolol 0.5% ophthalmic solution | Active comparator | Drug: timolol 0.5% ophthalmic solutionone drop in the morning and evening |
| latanoprost 0.005% ophthalmic solution | Active comparator | Drug: latanoprost 0.005% ophthalmic solutionplacebo in the morning and latanoprost .005% in the evening |
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 (two 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 (12 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 |
|---|---|---|
| i. Fixed combination of latanoprost 0.005% and timolol 0.5%Also: xalacom, xalcomone drop in the morning and placebo in the evening | Drug | Fixed combination of latanoprost 0.005% and timolol 0.5% |
| timolol 0.5% ophthalmic solutionAlso: timopticone drop in the morning and evening | Drug | timolol 0.5% ophthalmic solution |
| latanoprost 0.005% ophthalmic solutionAlso: xalatanplacebo in the morning and latanoprost .005% in the evening | Drug | latanoprost 0.005% ophthalmic solution |
Primary outcome
To demonstrate that the fixed combination of latanoprost and timolol has a better IOP-reducing effect than the individual monotherapies.
Time frame: 6 months
8 secondary outcomes
To examine, within treatment groups, the diurnal IOP reducing effect from baseline for all treatments at Week 26
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 compare 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 compare the proportion of patients reaching pre-specified (15, 18, and 21 mmHg) target diurnal IOPs between the treatment groups at Week 26
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 21 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
37 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 i. Fixed combination of latanoprost 0.005% and timolol 0.5%, timolol 0.5% ophthalmic solution and latanoprost 0.005% ophthalmic solution in people with Ocular Hypertension and Glaucoma, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 37 sites in Germany.
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 12 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 21 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 37 sites in Germany. 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?
To demonstrate that the fixed combination of latanoprost and timolol has a better IOP-reducing effect than the individual monotherapies. (time frame: 6 months). 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 21 Feb 2021.