Trial · NCT01999348
A Study of GANFORT® UD in Patients With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT) in a Medical Setting
NCT01999348, Completed, Allergan; results first posted 2015-12-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of GANFORT® UD in Patients With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT) in a Medical Setting. Trials, record NCT01999348. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01999348
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of GANFORT® UD in Patients With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT) in a Medical Setting
- NCT number
- NCT01999348
- Status
- Completed
- Enrollment
- 1,553 participants, actual
- Lead sponsor
- Allergan
- Conditions
- Glaucoma, Primary Open Angle, Ocular Hypertension
- Interventions
- Fixed Combination Bimatoprost and Timolol
- First posted
- 2013-12-03
- Last updated
- 2019-04-19
- Results first posted
- 2015-12-09
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Intraocular Pressure (IOP) in the Study Eye | Baseline, Final Visit (Week 8 to 12) | IOP is a measure of the fluid pressure inside the study eye. A result at the Final Visit that is lower than the result at Baseline indicates a reduction in IOP (improvement). |
| Secondary | Physician Assessment of IOP-Lowering Effect in the Study Eye Using a 3-Point Scale | Baseline, Final Visit (Week 8 to 12) | The physician assessed the effectiveness of Ganfort® UD with regard to IOP changes from Baseline using a 3-point scale where: 1=Better than expected (best), 2=As expected and 3=Worse than expected. The number of participants in each category is reported. |
| Secondary | Patient Assessment of Tolerability on a 4-Point Scale | Final Visit (Week 8 to 12) | The patient assessed the tolerability of Ganfort® UD using a 4-point scale where: 1=very good (best), 2=good, 3=moderate and 4=poor. The number of participants in each category is reported. |
| Secondary | Physician Assessment of Tolerability on a 4-Point Scale | Final Visit (Week 8 to 12) | The physician assessed the patient's tolerability of Ganfort® UD using a 4-point scale where: 1=very good (best), 2=good, 3=moderate and 4=poor. The number of participants in each category is reported. |
| Secondary | Percentage of Patients Who Discontinued Treatment | 12 Weeks | The percentage of participants who discontinued treatment with Ganfort® UD up to the Week 12 Final Visit |
| Secondary | Percentage of Patients Prescribed by the Physician to Continue Treatment | Final Visit (Week 8 to 12) | The percentage of participants who continued treatment with Ganfort® UD after Week 12. |
| Secondary | Physician Assessment of Patient Compliance Compared to Previous Treatment on a 3-Point Scale | Final Visit (Week 8 to 12) | The physician assessed patient compliance with Ganfort® UD compared to previous treatment using a 3-point scale where: 1=better (best), 2=equal and 3=worse. The number of participants in each category is reported. |
Source ClinicalTrials.gov
Outcomes7
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 Intraocular Pressure (IOP) in the Study Eye | Baseline, Final Visit (Week 8 to 12) | Participants from the Per-protocol population, all treated participants who had no major protocol violations, with complete data available at Baseline and Final Visit for analyses. | mmHg | MEAN |
| SECONDARY | Physician Assessment of IOP-Lowering Effect in the Study Eye Using a 3-Point Scale | Baseline, Final Visit (Week 8 to 12) | Per-protocol population included all treated participants who had no major protocol violations. | participants | NUMBER |
| SECONDARY | Patient Assessment of Tolerability on a 4-Point Scale | Final Visit (Week 8 to 12) | Per-protocol population included all treated participants who had no major protocol violations. | participants | NUMBER |
| SECONDARY | Physician Assessment of Tolerability on a 4-Point Scale | Final Visit (Week 8 to 12) | Per-protocol population included all treated participants who had no major protocol violations. | participants | NUMBER |
| SECONDARY | Percentage of Patients Who Discontinued Treatment | 12 Weeks | Per-protocol population included all treated participants who had no major protocol violations. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Patients Prescribed by the Physician to Continue Treatment | Final Visit (Week 8 to 12) | Per-protocol population included all treated participants who had no major protocol violations. | percentage of participants | NUMBER |
| SECONDARY | Physician Assessment of Patient Compliance Compared to Previous Treatment on a 3-Point Scale | Final Visit (Week 8 to 12) | All participants from the Per-protocol population, all treated participants who had no major protocol violations, who received previous treatment. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group22
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 Intraocular Pressure (IOP) in the Study Eye | Patients With POAG or OHT | Baseline | 22.18 | Standard Deviation 3.55 | mmHg |
| Change From Baseline in Intraocular Pressure (IOP) in the Study Eye | Patients With POAG or OHT | Final Visit | 16.11 | Standard Deviation 2.87 | mmHg |
| Physician Assessment of IOP-Lowering Effect in the Study Eye Using a 3-Point Scale | Patients With POAG or OHT | Better than expected | 497 | participants | |
| Physician Assessment of IOP-Lowering Effect in the Study Eye Using a 3-Point Scale | Patients With POAG or OHT | As expected | 729 | participants | |
| Physician Assessment of IOP-Lowering Effect in the Study Eye Using a 3-Point Scale | Patients With POAG or OHT | Worse than expected | 98 | participants | |
| Physician Assessment of IOP-Lowering Effect in the Study Eye Using a 3-Point Scale | Patients With POAG or OHT | Missing data | 67 | participants | |
| Patient Assessment of Tolerability on a 4-Point Scale | Patients With POAG or OHT | Very good | 788 | participants | |
| Patient Assessment of Tolerability on a 4-Point Scale | Patients With POAG or OHT | Good | 461 | participants | |
| Patient Assessment of Tolerability on a 4-Point Scale | Patients With POAG or OHT | Moderate | 45 | participants | |
| Patient Assessment of Tolerability on a 4-Point Scale | Patients With POAG or OHT | Poor | 50 | participants |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Patients With POAG or OHT | 1,553 | |
| Overall Study | COMPLETED | Patients With POAG or OHT | 1,433 | |
| Overall Study | NOT COMPLETED | Patients With POAG or OHT | 120 |
Source ClinicalTrials.gov
Adverse events1
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 | Death | General disorders | Patients With POAG or OHT | 1 | 1,553 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Patients With POAG or OHT | ||
| Total, other adverse events | Patients With POAG or OHT | 0 | 1,553 |
| Total, serious adverse events | Patients With POAG or OHT | 1 | 1,553 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 27703324 | 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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT01999348
GET https://conductscience.org/api/trials/v1/NCT01999348/results?page=2