A Phase 3 interventional study of bimatoprost/brimonidine tartrate/timolol fixed combination ophthalmic solution in Glaucoma and Ocular Hypertension, sponsored by Allergan. Completed at 1 site in India. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-09-19.
Sponsored by Allergan · Phase 3, Interventional, and Treatment
This study will investigate the safety and efficacy of Triple Combination Therapy (bimatoprost/brimonidine tartrate/timolol fixed combination ophthalmic solution) in patients with glaucoma or ocular hypertension who have elevated intraocular pressure (IOP) on brimonidine/timolol ophthalmic solution.
1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.
This study's enrollment of 126 is above the median of 65 across 1,272 interventional studies indexed under Glaucoma.
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Of its 91 completed or terminated interventional studies of FDA-regulated products, 89 (98%) have results posted.
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Exclusion Criteria:
One drop of Triple Combination Therapy (bimatoprost/brimonidine tartrate/timolol fixed combination ophthalmic solution) administered to each eye, twice daily for 12 weeks.
Drug: bimatoprost/brimonidine tartrate/timolol fixed combination ophthalmic solution
One drop of Triple Combination Therapy (bimatoprost/brimonidine tartrate/timolol fixed combination ophthalmic solution) administered to each eye, twice daily for 12 weeks.
Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) in the Study Eye
IOP is a measurement of the fluid pressure inside the eye. Mean diurnal IOP is the mean of the IOP values at hour 0, hour 2 and hour 8 at each visit in the study eye. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase in IOP (worsening).
Time frame: Baseline, Week 12
| Milestone | Triple Combination Therapy |
|---|---|
| Started | 126 |
| Completed | 113 |
| Not completed | 13 |
IOP is a measurement of the fluid pressure inside the eye. Mean diurnal IOP is the mean of the IOP values at hour 0, hour 2 and hour 8 at each visit in the study eye. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase in IOP (worsening).
| Millimeters of Mercury (mmHg) | Triple Combination Therapy |
|---|---|
| Baseline | 22.35 ± 3.417 |
| Change from Baseline at Week 12 | -3.98 ± 2.856 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Triple Combination Therapy | — | 0/121 (0%) | 20/121 (16.5%) |
| Event | Triple Combination Therapy |
|---|---|
| Conjunctival HyperaemiaEye disorders | 20/121 |
| Age, Customized(Participants) | Triple Combination Therapy |
|---|---|
| <45 years | 11 |
| 45 to 65 years | 84 |
| >65 years | 31 |
| Sex: Female, Male(Participants) | Triple Combination Therapy |
|---|---|
| Female | 48 |
| Male | 78 |
This study is completed, as verified in Jul 2013. You cannot join it, but the record below documents what was studied.
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