A Phase 3 interventional study of bimatoprost/brimonidine tartrate/timolol ophthalmic solution (Triple Combination Therapy) and Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution in Glaucoma, Open-Angle and Ocular Hypertension, sponsored by Allergan. Completed at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-12-20.
Sponsored by Allergan · Phase 3, Interventional, and Treatment
This study will evaluate the safety and efficacy of Triple Combination Therapy compared with Fixed Combination brimonidine tartrate/timolol ophthalmic solution in patients with primary open-angle glaucoma or ocular hypertension.
1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.
This study's enrollment of 185 is above the median of 65 across 1,272 interventional studies indexed under Glaucoma.
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Exclusion Criteria:
Triple Combination Therapy with bimatoprost/brimonidine tartrate/timolol ophthalmic solution. One drop of Triple Combination Therapy administered to each eye, twice daily for up to 12 months.
Drug: bimatoprost/brimonidine tartrate/timolol ophthalmic solution (Triple Combination Therapy)
Fixed Combination brimonidine tartrate/timolol ophthalmic solution (Combigan®). One drop of Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution administered to each eye, twice daily for up to 12 months.
Drug: Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution
One drop of Triple Combination Therapy administered to each eye, twice daily for up to 12 months.
One drop of Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution administered to each eye, twice daily for up to 12 months.
Also known as: COMBIGAN®
Change From Baseline in Mean Worse Eye Intraocular Pressure (IOP) Analyzed by Two-Sample T-Test
Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. IOP is evaluated at Hour 0 and Hour 2 in the worse eye, defined as the eye with the worse (higher) Hour 0 IOP at baseline. The mean of Hours 0 and 2 is calculated at Baseline and Week 12 in the worse 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). Data are analyzed using a two-sample t-test.
Time frame: Baseline, Week 12
Change From Baseline in Mean Worse Eye Intraocular Pressure (IOP) Analyzed by Mixed-Effect Model for Repeated Measure
Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. IOP is evaluated at Hour 0 and Hour 2 in the worse eye, defined as the eye with the worse (higher) Hour 0 IOP at baseline. The mean of Hours 0 and 2 is calculated at Baseline and Week 12 in the worse 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). Data are analyzed by a mixed-effect model for repeated measure.
Time frame: Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Month 6, Month 9, Month 12
Change From Baseline in Mean Worse Eye Intraocular Pressure (IOP) Analyzed by Analysis of Covariance (ANCOVA)
Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. IOP is evaluated at Hour 0 and Hour 2 in the worse eye, defined as the eye with the worse (higher) IOP at baseline. The mean of Hours 0 and 2 is calculated at Baseline and Week 12 in the worse 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). Data are analyzed by ANCOVA.
Time frame: Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Month 6, Month 9, Month 12
| Milestone | Triple Combination Therapy | Combigan® |
|---|---|---|
| Started | 90 | 95 |
| Completed | 76 | 83 |
| Not completed | 14 | 12 |
| Withdrew: Other reasons | 0 | 2 |
| Withdrew: Protocol violation | 3 | 2 |
| Withdrew: Personal reasons | 0 | 2 |
| Withdrew: Lack of efficacy | 1 | 0 |
| Withdrew: Adverse event | 10 | 6 |
| Milestone | Triple Combination Therapy | Combigan® |
|---|---|---|
| Started | 67 | 73 |
| Not enrolled in masked extension | 9 | 10 |
| Completed | 54 | 62 |
| Not completed | 13 | 11 |
| Withdrew: Adverse event | 3 | 6 |
| Withdrew: Other reasons | 4 | 4 |
| Withdrew: Personal reasons | 2 | 1 |
| Withdrew: Lost to follow-up | 1 | 0 |
| Withdrew: Pregnancy | 1 | 0 |
| Withdrew: Lack of efficacy | 2 | 0 |
Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. IOP is evaluated at Hour 0 and Hour 2 in the worse eye, defined as the eye with the worse (higher) Hour 0 IOP at baseline. The mean of Hours 0 and 2 is calculated at Baseline and Week 12 in the worse 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). Data are analyzed using a two-sample t-test.
| Millimeters of Mercury (mmHg) | Triple Combination Therapy | Combigan® |
|---|---|---|
| Baseline | 25.42 ± 2.902 | 24.43 ± 2.592 |
| Change from Baseline at Week 12 (N=85, 93) | -10.45 ± 3.175 | -8.28 ± 3.256 |
Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. IOP is evaluated at Hour 0 and Hour 2 in the worse eye, defined as the eye with the worse (higher) Hour 0 IOP at baseline. The mean of Hours 0 and 2 is calculated at Baseline and Week 12 in the worse 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). Data are analyzed by a mixed-effect model for repeated measure.
| Millimeters of Mercury (mmHg) | Triple Combination Therapy | Combigan® |
|---|---|---|
| Baseline | 25.42 ± 2.902 | 24.43 ± 2.592 |
| Change from Baseline at Week 1 (N=82, 91) | -11.63 ± 3.060 | -8.13 ± 2.969 |
| Change from Baseline at Week 2 (N=82, 87) | -11.24 ± 3.283 | -8.12 ± 2.942 |
| Change from Baseline at Week 4 (N=82, 88) | -10.88 ± 3.193 | -8.35 ± 3.100 |
| Change from Baseline at Week 8 (N=75, 87) | -10.53 ± 3.165 | -7.94 ± 3.453 |
| Change from Baseline at Week 12 (N=76, 83) | -10.56 ± 3.224 | -8.16 ± 3.161 |
| Change from Baseline at Month 6 (N=64, 69) | -10.41 ± 2.976 | -8.29 ± 3.221 |
| Change from Baseline at Month 9 (N=58, 67) | -10.29 ± 3.275 | -8.14 ± 2.937 |
| Change from Baseline at Month 12 (N=55, 63) | -9.38 ± 3.398 | -7.58 ± 3.486 |
Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. IOP is evaluated at Hour 0 and Hour 2 in the worse eye, defined as the eye with the worse (higher) IOP at baseline. The mean of Hours 0 and 2 is calculated at Baseline and Week 12 in the worse 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). Data are analyzed by ANCOVA.
| Millimeters of Mercury (mmHg) | Triple Combination Therapy | Combigan® |
|---|---|---|
| Baseline | 25.42 ± 2.902 | 24.43 ± 2.592 |
| Change from Baseline at Week 1 (N=82, 91) | -11.63 ± 3.060 | -8.13 ± 2.969 |
| Change from Baseline at Week 2 (N=84, 92) | -11.20 ± 3.290 | -8.28 ± 3.076 |
| Change from Baseline at Week 4 (N=85, 93) | -10.85 ± 3.180 | -8.53 ± 3.228 |
| Change from Baseline at Week 8 (N=85, 93) | -10.44 ± 3.105 | -8.07 ± 3.521 |
| Change from Baseline at Week 12 (N=85, 93) | -10.45 ± 3.175 | -8.28 ± 3.256 |
| Change from Baseline at Month 6 (N=67, 73) | -10.32 ± 2.965 | -8.42 ± 3.252 |
| Change from Baseline at Month 9 (N=67, 73) | -10.09 ± 3.349 | -8.17 ± 3.031 |
| Change from Baseline at Month 12 (N=67, 73) | -9.36 ± 3.368 | -7.77 ± 3.489 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Triple Combination Therapy | — | 1/90 (1.1%) | 84/90 (93.3%) |
| Combigan® | — | 1/95 (1.1%) | 77/95 (81.1%) |
| Event | Triple Combination Therapy | Combigan® |
|---|---|---|
| Rotator Cuff SyndromeMusculoskeletal and connective tissue disorders | 1/90 | 0/95 |
| Tendon ruptureInjury, poisoning and procedural complications | 0/90 | 1/95 |
| Event | Triple Combination Therapy | Combigan® |
|---|---|---|
| Conjunctival hyperaemiaEye disorders | 54/90 | 28/95 |
| Punctate keratitisEye disorders | 25/90 | 19/95 |
| BlepharitisEye disorders | 15/90 | 12/95 |
| Conjunctival folliclesEye disorders | 7/90 | 15/95 |
| Eye pruritusEye disorders | 12/90 | 7/95 |
| Eye irritationEye disorders | 11/90 | 3/95 |
| MeibomianitisEye disorders | 10/90 | 8/95 |
| Erythema of eyelidEye disorders | 9/90 | 7/95 |
| CataractEye disorders | 8/90 | 3/95 |
| Visual Field DefectNervous system disorders | 7/90 | 7/95 |
| Age, Customized(Participants) | Triple Combination Therapy | Combigan® | Total |
|---|---|---|---|
| ≤65 years | 68 | 62 | 130 |
| >65 years | 22 | 33 | 55 |
| Gender(Participants) | Triple Combination Therapy | Combigan® | Total |
|---|---|---|---|
| Female | 53 | 63 | 116 |
| Male | 37 | 32 | 69 |
This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
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