Trial · NCT01217606
Safety and Efficacy of Triple Combination Therapy in Patients With Primary Open-Angle Glaucoma or Ocular Hypertension
NCT01217606, Phase 3, Completed, Allergan; results first posted 2015-11-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Efficacy of Triple Combination Therapy in Patients With Primary Open-Angle Glaucoma or Ocular Hypertension. Trials, record NCT01217606. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01217606
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of Triple Combination Therapy in Patients With Primary Open-Angle Glaucoma or Ocular Hypertension
- NCT number
- NCT01217606
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 185 participants, actual
- Lead sponsor
- Allergan
- Conditions
- Glaucoma, Open-Angle, Ocular Hypertension
- Interventions
- bimatoprost/brimonidine tartrate/timolol ophthalmic solution (Triple Combination Therapy), Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution
- First posted
- 2010-10-08
- Last updated
- 2016-12-20
- Results first posted
- 2015-11-09
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Mean Worse Eye Intraocular Pressure (IOP) Analyzed by Two-Sample T-Test | Baseline, Week 12 | 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. |
| Secondary | Change From Baseline in Mean Worse Eye Intraocular Pressure (IOP) Analyzed by Mixed-Effect Model for Repeated Measure | Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Month 6, Month 9, Month 12 | 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. |
| Secondary | Change From Baseline in Mean Worse Eye Intraocular Pressure (IOP) Analyzed by Analysis of Covariance (ANCOVA) | Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Month 6, Month 9, Month 12 | 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. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Mean Worse Eye Intraocular Pressure (IOP) Analyzed by Two-Sample T-Test | Baseline, Week 12 | Modified Intent to Treat: all randomized patients with at least one post-baseline efficacy evaluation | Millimeters of Mercury (mmHg) | MEAN |
| SECONDARY | Change From Baseline in Mean Worse Eye Intraocular Pressure (IOP) Analyzed by Mixed-Effect Model for Repeated Measure | Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Month 6, Month 9, Month 12 | Modified Intent to Treat: all randomized patients with at least one post-baseline efficacy evaluation and who have data at the noted time point (no missing imputation) | Millimeters of Mercury (mmHg) | MEAN |
| SECONDARY | Change From Baseline in Mean Worse Eye Intraocular Pressure (IOP) Analyzed by Analysis of Covariance (ANCOVA) | Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Month 6, Month 9, Month 12 | Modified Intent to Treat: all randomized patients with at least one post-baseline efficacy evaluation | Millimeters of Mercury (mmHg) | MEAN |
Source ClinicalTrials.gov
Results by group40
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Mean Worse Eye Intraocular Pressure (IOP) Analyzed by Two-Sample T-Test | Triple Combination Therapy | Baseline | 25.42 | Standard Deviation 2.902 | Millimeters of Mercury (mmHg) |
| Change From Baseline in Mean Worse Eye Intraocular Pressure (IOP) Analyzed by Two-Sample T-Test | Combigan® | Baseline | 24.43 | Standard Deviation 2.592 | Millimeters of Mercury (mmHg) |
| Change From Baseline in Mean Worse Eye Intraocular Pressure (IOP) Analyzed by Two-Sample T-Test | Triple Combination Therapy | Change from Baseline at Week 12 (N=85, 93) | -10.45 | Standard Deviation 3.175 | Millimeters of Mercury (mmHg) |
| Change From Baseline in Mean Worse Eye Intraocular Pressure (IOP) Analyzed by Two-Sample T-Test | Combigan® | Change from Baseline at Week 12 (N=85, 93) | -8.28 | Standard Deviation 3.256 | Millimeters of Mercury (mmHg) |
| Change From Baseline in Mean Worse Eye Intraocular Pressure (IOP) Analyzed by Mixed-Effect Model for Repeated Measure | Triple Combination Therapy | Baseline | 25.42 | Standard Deviation 2.902 | Millimeters of Mercury (mmHg) |
| Change From Baseline in Mean Worse Eye Intraocular Pressure (IOP) Analyzed by Mixed-Effect Model for Repeated Measure | Combigan® | Baseline | 24.43 | Standard Deviation 2.592 | Millimeters of Mercury (mmHg) |
| Change From Baseline in Mean Worse Eye Intraocular Pressure (IOP) Analyzed by Mixed-Effect Model for Repeated Measure | Triple Combination Therapy | Change from Baseline at Week 1 (N=82, 91) | -11.63 | Standard Deviation 3.060 | Millimeters of Mercury (mmHg) |
| Change From Baseline in Mean Worse Eye Intraocular Pressure (IOP) Analyzed by Mixed-Effect Model for Repeated Measure | Combigan® | Change from Baseline at Week 1 (N=82, 91) | -8.13 | Standard Deviation 2.969 | Millimeters of Mercury (mmHg) |
| Change From Baseline in Mean Worse Eye Intraocular Pressure (IOP) Analyzed by Mixed-Effect Model for Repeated Measure | Triple Combination Therapy | Change from Baseline at Week 2 (N=82, 87) | -11.24 | Standard Deviation 3.283 | Millimeters of Mercury (mmHg) |
| Change From Baseline in Mean Worse Eye Intraocular Pressure (IOP) Analyzed by Mixed-Effect Model for Repeated Measure | Combigan® | Change from Baseline at Week 2 (N=82, 87) | -8.12 | Standard Deviation 2.942 | Millimeters of Mercury (mmHg) |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 results by groupParticipant flow14
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Initial Treatment Phase | STARTED | Triple Combination Therapy | 90 | |
| Initial Treatment Phase | STARTED | Combigan® | 95 | |
| Initial Treatment Phase | COMPLETED | Triple Combination Therapy | 76 | |
| Initial Treatment Phase | COMPLETED | Combigan® | 83 | |
| Initial Treatment Phase | NOT COMPLETED | Triple Combination Therapy | 14 | |
| Initial Treatment Phase | NOT COMPLETED | Combigan® | 12 | |
| 9-Month Masked Extension | STARTED | Triple Combination Therapy | 67 | |
| 9-Month Masked Extension | STARTED | Combigan® | 73 | |
| 9-Month Masked Extension | Not Enrolled in Masked Extension | Triple Combination Therapy | 9 | |
| 9-Month Masked Extension | Not Enrolled in Masked Extension | Combigan® | 10 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 participant flowAdverse events36
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Conjunctival hyperaemia | Eye disorders | Triple Combination Therapy | 54 | 90 | |
| other | Conjunctival hyperaemia | Eye disorders | Combigan® | 28 | 95 | |
| other | Punctate keratitis | Eye disorders | Triple Combination Therapy | 25 | 90 | |
| other | Punctate keratitis | Eye disorders | Combigan® | 19 | 95 | |
| other | Eye pruritus | Eye disorders | Triple Combination Therapy | 12 | 90 | |
| other | Eye pruritus | Eye disorders | Combigan® | 7 | 95 | |
| other | Blepharitis | Eye disorders | Triple Combination Therapy | 15 | 90 | |
| other | Blepharitis | Eye disorders | Combigan® | 12 | 95 | |
| other | Erythema of eyelid | Eye disorders | Triple Combination Therapy | 9 | 90 | |
| other | Erythema of eyelid | Eye disorders | Combigan® | 7 | 95 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Triple Combination Therapy | ||
| Total, all-cause mortality | Combigan® | ||
| Total, other adverse events | Triple Combination Therapy | 84 | 90 |
| Total, other adverse events | Combigan® | 77 | 95 |
| Total, serious adverse events | Triple Combination Therapy | 1 | 90 |
| Total, serious adverse events | Combigan® | 1 | 95 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32089329 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Triple Combination Therapy vs Combigan®: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01217606
GET https://conductscience.org/api/trials/v1/NCT01217606/results?page=2