Trial · NCT01241240
Safety and Efficacy of Triple Combination Therapy in Patients With Primary Open-Angle Glaucoma or Ocular Hypertension
NCT01241240, Phase 3, Completed, Allergan; results first posted 2014-09-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Efficacy of Triple Combination Therapy in Patients With Primary Open-Angle Glaucoma or Ocular Hypertension. Trials, record NCT01241240. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01241240
On this page
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
- NCT01241240
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 192 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
- 2010-11-16
- Last updated
- 2014-09-10
- Results first posted
- 2014-09-10
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) at Week 12 | Baseline, Week 12 | IOP is a measurement of the fluid pressure inside the eye. For each eye, the IOP was either the average of 2 measurements, or, if a third measurement was required, the median of the 3 measurements. The worse eye was determined based on the IOP results at Baseline. The mean worse eye IOP was the average of the IOP measurements of the worse eye at hours 0 and 2 at week 12. A negative change from Baseline indicated improvement. |
| Secondary | Change From Baseline in Mean Worse Eye IOP | Baseline, Weeks 1, 2, 4 and 8 | IOP is a measurement of the fluid pressure inside the eye. For each eye, the IOP was either the average of 2 measurements, or, if a third measurement was required, the median of the 3 measurements. The worse eye was determined based on the IOP results at Baseline. The mean worse eye IOP was the average of the IOP measurements of the worse eye at hours 0 and 2 at each visit. A negative change from Baseline indicated improvement. |
| Secondary | Mean Worse Eye IOP | Weeks 1, 2, 4, 8 and 12 | IOP is a measurement of the fluid pressure inside the eye. For each eye, the IOP was either the average of 2 measurements, or, if a third measurement was required, the median of the 3 measurements. The worse eye was determined based on the IOP results at Baseline. The mean worse eye IOP was the average of the IOP measurements of the worse eye at hours 0 and 2 at each time-point. |
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) at Week 12 | Baseline, Week 12 | Participants from the modified Intent-to-treat (mITT) population, that included all randomized participants who had at least 1 post-baseline IOP measurement, with data available for analysis at the given time-point. | mmHg | MEAN |
| SECONDARY | Change From Baseline in Mean Worse Eye IOP | Baseline, Weeks 1, 2, 4 and 8 | Participants from the mITT population, that included all randomized participants who had at least 1 post-baseline IOP measurement, with data available for analysis at the given time-point. | mmHg | MEAN |
| SECONDARY | Mean Worse Eye IOP | Weeks 1, 2, 4, 8 and 12 | Participants from the mITT population, that included all randomized participants who had at least 1 post-baseline IOP measurement, with data available for analysis at the given time-point. | mmHg | MEAN |
Source ClinicalTrials.gov
Results by group24
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) at Week 12 | Triple Combination Therapy | Baseline (n=93,95) | 24.62 | Standard Deviation 2.475 | mmHg |
| Change From Baseline in Mean Worse Eye Intraocular Pressure (IOP) at Week 12 | Combigan® | Baseline (n=93,95) | 25.12 | Standard Deviation 2.178 | mmHg |
| Change From Baseline in Mean Worse Eye Intraocular Pressure (IOP) at Week 12 | Triple Combination Therapy | Change from Baseline at Week 12 (n=93,94) | -10.03 | Standard Deviation 2.661 | mmHg |
| Change From Baseline in Mean Worse Eye Intraocular Pressure (IOP) at Week 12 | Combigan® | Change from Baseline at Week 12 (n=93,94) | -9.18 | Standard Deviation 2.566 | mmHg |
| Change From Baseline in Mean Worse Eye IOP | Triple Combination Therapy | Baseline (n=93,95) | 24.62 | Standard Deviation 2.475 | mmHg |
| Change From Baseline in Mean Worse Eye IOP | Combigan® | Baseline (n=93,95) | 25.12 | Standard Deviation 2.178 | mmHg |
| Change From Baseline in Mean Worse Eye IOP | Triple Combination Therapy | Change from Baseline at Week 1 (n=91,89) | -10.18 | Standard Deviation 3.149 | mmHg |
| Change From Baseline in Mean Worse Eye IOP | Combigan® | Change from Baseline at Week 1 (n=91,89) | -8.90 | Standard Deviation 3.044 | mmHg |
| Change From Baseline in Mean Worse Eye IOP | Triple Combination Therapy | Change from Baseline at Week 2 (n=88,93) | -10.40 | Standard Deviation 2.802 | mmHg |
| Change From Baseline in Mean Worse Eye IOP | Combigan® | Change from Baseline at Week 2 (n=88,93) | -9.06 | Standard Deviation 2.925 | mmHg |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Triple Combination Therapy | 94 | |
| Overall Study | STARTED | Combigan® | 98 | |
| Overall Study | COMPLETED | Triple Combination Therapy | 86 | |
| Overall Study | COMPLETED | Combigan® | 89 | |
| Overall Study | NOT COMPLETED | Triple Combination Therapy | 8 | |
| Overall Study | NOT COMPLETED | Combigan® | 9 |
Source ClinicalTrials.gov
Adverse events20
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 | 22 | 93 | |
| other | Conjunctival hyperaemia | Eye disorders | Combigan® | 4 | 98 | |
| other | Eye irritation | Eye disorders | Triple Combination Therapy | 13 | 93 | |
| other | Eye irritation | Eye disorders | Combigan® | 4 | 98 | |
| other | Dry eye | Eye disorders | Triple Combination Therapy | 10 | 93 | |
| other | Dry eye | Eye disorders | Combigan® | 2 | 98 | |
| other | Eye pruritus | Eye disorders | Triple Combination Therapy | 6 | 93 | |
| other | Eye pruritus | Eye disorders | Combigan® | 2 | 98 | |
| other | Somnolence | Nervous system disorders | Triple Combination Therapy | 5 | 93 | |
| other | Somnolence | Nervous system disorders | Combigan® | 8 | 98 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 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 | 57 | 93 |
| Total, other adverse events | Combigan® | 25 | 98 |
| Total, serious adverse events | Triple Combination Therapy | 3 | 93 |
| Total, serious adverse events | Combigan® | 0 | 98 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 29057117 | 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/NCT01241240
GET https://conductscience.org/api/trials/v1/NCT01241240/results?page=2