Trial · NCT00735449
Comparing Efficacy and Safety of Combigan With Timolol Adjunctive to Xalatan in Glaucoma or Ocular Hypertension Subjects
NCT00735449, Phase 4, Completed, Allergan; results first posted 2011-11-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Comparing Efficacy and Safety of Combigan With Timolol Adjunctive to Xalatan in Glaucoma or Ocular Hypertension Subjects. Trials, record NCT00735449. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00735449
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparing Efficacy and Safety of Combigan With Timolol Adjunctive to Xalatan in Glaucoma or Ocular Hypertension Subjects
- NCT number
- NCT00735449
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 204 participants, actual
- Lead sponsor
- Allergan
- Conditions
- Glaucoma, Ocular Hypertension
- Interventions
- Fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5%, timolol maleate 0.5%, latanoprost 0.005%
- First posted
- 2008-08-15
- Last updated
- 2019-04-23
- Results first posted
- 2011-11-24
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Intraocular Pressure (IOP) at 10 AM at Week 12 | Week 12 | Mean IOP at 10 AM at week 12. IOP is a measurement of the fluid pressure in the eye. |
| Secondary | Mean Intraocular Pressure (IOP) at 10 AM at Week 6 | Week 6 | Mean IOP at 10 AM at week 6. IOP is a measurement of the fluid pressure inside the eye. |
| Secondary | Mean Intraocular Pressure (IOP) at 8 AM at Week 12 | Week 12 | Mean IOP at 8 AM at week 12. IOP is a measurement of the fluid pressure inside the eye. |
| Secondary | Mean Intraocular Pressure (IOP) at 8 AM at Week 6 | Week 6 | Mean IOP at 8 AM at week 6. IOP is a measurement of the fluid pressure inside the eye. |
| Secondary | Number of Subjects With Adverse Events | Week 12 | Number of subjects with adverse events, defined as any untoward medical occurrence in a subject, during the study (reported through the week 12 visit). |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Mean Intraocular Pressure (IOP) at 10 AM at Week 6 | Week 6 | Per-protocol, which included all patients who started the study (randomized) and had at least one follow-up visit. | Millimeters of mercury (mmHg) | MEAN |
| PRIMARY | Mean Intraocular Pressure (IOP) at 10 AM at Week 12 | Week 12 | Per-protocol, which included all patients who started the study (randomized) and had at least one follow-up visit and who were assessed for this outcome measure at the Week 12 visit. | Millimeters of mercury (mmHg) | MEAN |
| SECONDARY | Mean Intraocular Pressure (IOP) at 8 AM at Week 12 | Week 12 | Per-protocol, which included all patients who started the study (randomized) and had at least one follow-up visit and who were assessed for this outcome measure at the Week 12 visit. | Millimeters of mercury (mmHg) | MEAN |
| SECONDARY | Mean Intraocular Pressure (IOP) at 8 AM at Week 6 | Week 6 | Per-protocol, which included all patients who started the study (randomized) and had at least one follow-up visit. | Millimeters of mercury (mmHg) | MEAN |
| SECONDARY | Number of Subjects With Adverse Events | Week 12 | Safety population, which included all patients who started the study (randomized) and were treated. | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Intraocular Pressure (IOP) at 10 AM at Week 6 | Combigan® | 15.9 | Standard Deviation 3.10 | Millimeters of mercury (mmHg) | |
| Mean Intraocular Pressure (IOP) at 10 AM at Week 6 | Timolol Maleate 0.5% | 16.7 | Standard Deviation 2.78 | Millimeters of mercury (mmHg) | |
| Mean Intraocular Pressure (IOP) at 10 AM at Week 12 | Combigan® | 15.1 | Standard Deviation 2.59 | Millimeters of mercury (mmHg) | |
| Mean Intraocular Pressure (IOP) at 10 AM at Week 12 | Timolol Maleate 0.5% | 16.9 | Standard Deviation 2.46 | Millimeters of mercury (mmHg) | |
| Mean Intraocular Pressure (IOP) at 8 AM at Week 12 | Combigan® | 17.0 | Standard Deviation 2.55 | Millimeters of mercury (mmHg) | |
| Mean Intraocular Pressure (IOP) at 8 AM at Week 12 | Timolol Maleate 0.5% | 17.7 | Standard Deviation 2.58 | Millimeters of mercury (mmHg) | |
| Mean Intraocular Pressure (IOP) at 8 AM at Week 6 | Combigan® | 17.3 | Standard Deviation 2.87 | Millimeters of mercury (mmHg) | |
| Mean Intraocular Pressure (IOP) at 8 AM at Week 6 | Timolol Maleate 0.5% | 17.8 | Standard Deviation 3.17 | Millimeters of mercury (mmHg) | |
| Number of Subjects With Adverse Events | Combigan® | 15 | Participants | ||
| Number of Subjects With Adverse Events | Timolol Maleate 0.5% | 13 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Combigan® | 102 | |
| Overall Study | STARTED | Timolol Maleate 0.5% | 102 | |
| Overall Study | COMPLETED | Combigan® | 95 | |
| Overall Study | COMPLETED | Timolol Maleate 0.5% | 96 | |
| Overall Study | NOT COMPLETED | Combigan® | 7 | |
| Overall Study | NOT COMPLETED | Timolol Maleate 0.5% | 6 |
Source ClinicalTrials.gov
Adverse events4
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 |
|---|---|---|---|---|---|---|
| serious | Acute exacerbation of COPD | Respiratory, thoracic and mediastinal disorders | Combigan® | 0 | 102 | |
| serious | Acute exacerbation of COPD | Respiratory, thoracic and mediastinal disorders | Timolol Maleate 0.5% | 1 | 102 | |
| serious | Bacterial bronchitis | Infections and infestations | Combigan® | 0 | 102 | |
| serious | Bacterial bronchitis | Infections and infestations | Timolol Maleate 0.5% | 1 | 102 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Combigan® | ||
| Total, all-cause mortality | Timolol Maleate 0.5% | ||
| Total, other adverse events | Combigan® | 0 | 102 |
| Total, other adverse events | Timolol Maleate 0.5% | 0 | 102 |
| Total, serious adverse events | Combigan® | 0 | 102 |
| Total, serious adverse events | Timolol Maleate 0.5% | 2 | 102 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 21792284 | BACKGROUND |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Combigan® vs Timolol Maleate 0.5%: Number of Subjects With Adverse Events | Trial comparisons |
| Combigan® vs Timolol Maleate 0.5%: serious adverse events | 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/NCT00735449
GET https://conductscience.org/api/trials/v1/NCT00735449/registered