Trial · NCT01853085
A Study of Patients With Primary Open Angle Glaucoma or Ocular Hypertension Switched to Lumigan® UD Monotherapy for Medical Reasons
NCT01853085, Completed, Allergan; results first posted 2015-05-28
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of Patients With Primary Open Angle Glaucoma or Ocular Hypertension Switched to Lumigan® UD Monotherapy for Medical Reasons. Trials, record NCT01853085. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01853085
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Patients With Primary Open Angle Glaucoma or Ocular Hypertension Switched to Lumigan® UD Monotherapy for Medical Reasons
- NCT number
- NCT01853085
- Status
- Completed
- Enrollment
- 1,830 participants, actual
- Lead sponsor
- Allergan
- Conditions
- Glaucoma, Primary Open Angle, Ocular Hypertension
- Interventions
- Bimatoprost Ophthalmic Solution
- First posted
- 2013-05-14
- Last updated
- 2019-04-19
- Results first posted
- 2015-05-28
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Intraocular Pressure (IOP) in the Study Eye at Baseline | Baseline | IOP is a measurement of the fluid pressure inside the study eye. |
| Primary | IOP in the Study Eye at Week 12 | Week 12 | IOP is a measurement of the fluid pressure inside the study eye. |
| Secondary | Physician Assessment of IOP-Lowering Effect in the Study Eye on a 3-Point Scale | Baseline, 12 Weeks | IOP is a measurement of the fluid pressure inside the eye. Physicians evaluate IOP change from baseline in the study eye as better than expected, as expected, and worse than expected. The numbers of patients in each category are presented. |
| Secondary | Patient Assessment of Tolerability on a 4-Point Scale | 12 Weeks | Patient assessment of tolerability is assessed using a 4-point scale (very good, good, moderate, and poor). The numbers of patients in each category are presented. |
| Secondary | Physician Assessment of Tolerability on a 4-Point Scale | 12 Weeks | Physician assessment of tolerability is assessed using a 4-point scale (very good, good, moderate, and poor). The numbers of patients in each category are presented. |
| Secondary | Number of Patients Who Discontinue Treatment With Lumigan® UD Prior to 12 Weeks of Treatment | 12 Weeks | Patient discontinuation of treatment with Lumigan® UD prior to 12 weeks of treatment is assessed as Yes or No. |
| Secondary | Number of Patients Who Continue Treatment | 12 Weeks | Patient continuation of treatment with Lumigan® UD after the end of study participation is assessed as Yes or No. |
| Secondary | Physician Assessment of Patient Compliance Compared to Previous Treatment on a 3-Point Scale | 12 Weeks | Physician assessment of patient compliance compared to previous therapy is assessed on a 3-point scale (better, equal, and worse). The numbers of patients in each category are presented. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Intraocular Pressure (IOP) in the Study Eye at Baseline | Baseline | All patients with data for this outcome measure | Millimeters of Mercury (mmHg) | MEAN |
| SECONDARY | Physician Assessment of IOP-Lowering Effect in the Study Eye on a 3-Point Scale | Baseline, 12 Weeks | All patients with data for this outcome measure | Patients | NUMBER |
| SECONDARY | Patient Assessment of Tolerability on a 4-Point Scale | 12 Weeks | All patients with data for this outcome measure | Patients | NUMBER |
| SECONDARY | Physician Assessment of Tolerability on a 4-Point Scale | 12 Weeks | All patients with data for this outcome measure | Patients | NUMBER |
| SECONDARY | Number of Patients Who Discontinue Treatment With Lumigan® UD Prior to 12 Weeks of Treatment | 12 Weeks | All enrolled patients | Patients | NUMBER |
| SECONDARY | Number of Patients Who Continue Treatment | 12 Weeks | All enrolled patients | Patients | NUMBER |
| SECONDARY | Physician Assessment of Patient Compliance Compared to Previous Treatment on a 3-Point Scale | 12 Weeks | All patients with data for this outcome measure | Patients | NUMBER |
| PRIMARY | IOP in the Study Eye at Week 12 | Week 12 | All patients with data for this outcome measure | mmHg | MEAN |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Intraocular Pressure (IOP) in the Study Eye at Baseline | Patients With POAG or OHT | 21.15 | Standard Deviation 3.43 | Millimeters of Mercury (mmHg) | |
| Physician Assessment of IOP-Lowering Effect in the Study Eye on a 3-Point Scale | Patients With POAG or OHT | Better than Expected | 649 | Patients | |
| Physician Assessment of IOP-Lowering Effect in the Study Eye on a 3-Point Scale | Patients With POAG or OHT | As Expected | 916 | Patients | |
| Physician Assessment of IOP-Lowering Effect in the Study Eye on a 3-Point Scale | Patients With POAG or OHT | Worse than Expected | 151 | Patients | |
| Patient Assessment of Tolerability on a 4-Point Scale | Patients With POAG or OHT | Very Good | 913 | Patients | |
| Patient Assessment of Tolerability on a 4-Point Scale | Patients With POAG or OHT | Good | 670 | Patients | |
| Patient Assessment of Tolerability on a 4-Point Scale | Patients With POAG or OHT | Moderate | 73 | Patients | |
| Patient Assessment of Tolerability on a 4-Point Scale | Patients With POAG or OHT | Poor | 74 | Patients | |
| Physician Assessment of Tolerability on a 4-Point Scale | Patients With POAG or OHT | Very Good | 982 | Patients | |
| Physician Assessment of Tolerability on a 4-Point Scale | Patients With POAG or OHT | Good | 648 | Patients |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 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 | 1,830 | |
| Overall Study | COMPLETED | Patients With POAG or OHT | 1,595 | |
| Overall Study | NOT COMPLETED | Patients With POAG or OHT | 235 |
Source ClinicalTrials.gov
Adverse events2
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 | Cataract Operation | Eye disorders | Patients With POAG or OHT | 1 | 1,830 | |
| serious | Death | General disorders | Patients With POAG or OHT | 1 | 1,830 |
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 | 1,830 |
| Total, serious adverse events | Patients With POAG or OHT | 2 | 1,830 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 27672307 | 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/NCT01853085
GET https://conductscience.org/api/trials/v1/NCT01853085/registered