Trial · NCT01833741
A Study of LUMIGAN® RC in the Clinical Setting
NCT01833741, Phase 4, Completed, Allergan; results first posted 2013-09-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of LUMIGAN® RC in the Clinical Setting. Trials, record NCT01833741. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01833741
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of LUMIGAN® RC in the Clinical Setting
- NCT number
- NCT01833741
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 1,137 participants, actual
- Lead sponsor
- Allergan
- Conditions
- Glaucoma, Primary Open Angle, Ocular Hypertension
- Interventions
- Bimatoprost 0.01%
- First posted
- 2013-04-17
- Last updated
- 2013-09-26
- Results first posted
- 2013-09-26
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Treatment-Naive Patients With Ocular Hyperemia | Week 12 | Hyperemia is engorgement of the blood vessels (redness) of the bulbar conjunctiva of the eye (the clear membrane covering the white surface of the eye). Hyperemia is graded on a 5 point scale where 0=none (normal), 0.5=trace (trace flush reddish pink), 1=Mild (mild flush reddish color), 2=Moderate (bright red color) and 3=severe (deep bright diffuse redness). Naive patients did not use glaucoma medication prior to study entry. |
| Primary | Percentage of Previously Treated (Switched) Patients With Ocular Hyperemia | Week 12 | Hyperemia is engorgement of the blood vessels (redness) of the bulbar conjunctiva of the eye (the clear membrane covering the white surface of the eye). Hyperemia is graded on a 5 point scale where 0=none (normal), 0.5=trace (trace flush reddish pink), 1=Mild (mild flush reddish color), 2=Moderate (bright red color) and 3=severe (deep bright diffuse redness). Previously treated patients used glaucoma medication prior to study entry and were switched from their previous therapy to study treatment. |
| Primary | Percentage of Patients Treated With Adjunctive Therapy With Ocular Hyperemia | Week 12 | Hyperemia is engorgement of the blood vessels (redness) of the bulbar conjunctiva of the eye (the clear membrane covering the white surface of the eye). Hyperemia is graded on a 5 point scale where 0=none (normal), 0.5=trace (trace flush reddish pink), 1=Mild (mild flush reddish color), 2=Moderate (bright red color) and 3=severe (deep bright diffuse redness). Previously treated patients used glaucoma medication prior to study entry and added study treatment as adjunctive therapy. |
| Secondary | Percent Change From Baseline in Intraocular Pressure (IOP) in the Study Eye of Treatment-Naive Patients | Baseline, 12 Weeks | IOP is a measurement of the fluid pressure inside the eye. Naive patients did not use glaucoma medication prior to study entry. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase (worsening). |
| Secondary | Percent Change From Baseline in IOP in the Study Eye of Previously Treated (Switched) Patients | Baseline, 12 Weeks | IOP is a measurement of the fluid pressure inside the eye. Previously treated patients used glaucoma medication prior to study entry and were switched from their previous therapy to study treatment. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase (worsening). |
| Secondary | Percent Change From Baseline in IOP in the Study Eye of Patients Treated With Adjunctive Therapy | Baseline, 12 Weeks | IOP is a measurement of the fluid pressure inside the eye. Previously treated patients used glaucoma medication prior to study entry and added study treatment as adjunctive therapy. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase (worsening). |
| Secondary | Change From Baseline in IOP in the Study Eye of Treatment-Naive Patients | Baseline, Week 6, Week 12 | IOP is a measurement of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase (worsening). |
| Secondary | Change From Baseline in IOP in the Study Eye of Previously Treated (Switched) Patients | Baseline, Week 6, Week 12 | IOP is a measurement of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase (worsening). |
| Secondary | Change From Baseline in IOP in the Study Eye of Patients Treated With Adjunctive Therapy | Baseline, Week 6, Week 12 | IOP is a measurement of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase (worsening). |
| Secondary | Percentage of Patients Discontinuing Due to Ocular Adverse Events | 12 Weeks | Ocular adverse events are defined as any untoward medical occurrence in a patient's eye(s) during study participation, regardless of relationship to treatment. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Treatment-Naive Patients With Ocular Hyperemia | Week 12 | All patients who were consented and completed the Baseline visit, and who had data for Week 12 | Percentage of Patients | NUMBER |
| SECONDARY | Percent Change From Baseline in Intraocular Pressure (IOP) in the Study Eye of Treatment-Naive Patients | Baseline, 12 Weeks | Intent to Treat: all patients who were consented and completed the Baseline visit | Percent Change | MEAN |
| SECONDARY | Percent Change From Baseline in IOP in the Study Eye of Previously Treated (Switched) Patients | Baseline, 12 Weeks | Intent to Treat: all patients who were consented and completed the Baseline visit | Percent Change | MEAN |
| SECONDARY | Percent Change From Baseline in IOP in the Study Eye of Patients Treated With Adjunctive Therapy | Baseline, 12 Weeks | Intent to Treat: all patients who were consented and completed the Baseline visit | Percent Change | MEAN |
| SECONDARY | Change From Baseline in IOP in the Study Eye of Treatment-Naive Patients | Baseline, Week 6, Week 12 | Intent to Treat: all patients who were consented and completed the Baseline visit | Millimeters of Mercury (mmHg) | MEAN |
| SECONDARY | Change From Baseline in IOP in the Study Eye of Previously Treated (Switched) Patients | Baseline, Week 6, Week 12 | Intent to Treat: all patients who were consented and completed the Baseline visit | Millimeters of Mercury (mmHg) | MEAN |
| SECONDARY | Change From Baseline in IOP in the Study Eye of Patients Treated With Adjunctive Therapy | Baseline, Week 6, Week 12 | Intent to Treat: all patients who were consented and completed the Baseline visit | Millimeters of Mercury (mmHg) | MEAN |
| SECONDARY | Percentage of Patients Discontinuing Due to Ocular Adverse Events | 12 Weeks | Intent to Treat: all patients who were consented and completed the Baseline visit | Percentage of Patients | NUMBER |
| PRIMARY | Percentage of Previously Treated (Switched) Patients With Ocular Hyperemia | Week 12 | All patients who were consented and completed the Baseline visit, and who had data for Week 12 | Percentage of Patients | NUMBER |
| PRIMARY | Percentage of Patients Treated With Adjunctive Therapy With Ocular Hyperemia | Week 12 | All patients who were consented and completed the Baseline visit, and who had data for Week 12 | Percentage of Patients | NUMBER |
Source ClinicalTrials.gov
Results by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Treatment-Naive Patients With Ocular Hyperemia | Bimatoprost 0.01% | 0 (none) | 32.2 | Percentage of Patients | |
| Percentage of Treatment-Naive Patients With Ocular Hyperemia | Bimatoprost 0.01% | +0.5 (trace) | 39.8 | Percentage of Patients | |
| Percentage of Treatment-Naive Patients With Ocular Hyperemia | Bimatoprost 0.01% | +1 (mild) | 21.3 | Percentage of Patients | |
| Percentage of Treatment-Naive Patients With Ocular Hyperemia | Bimatoprost 0.01% | +2 (moderate) | 5.9 | Percentage of Patients | |
| Percentage of Treatment-Naive Patients With Ocular Hyperemia | Bimatoprost 0.01% | +3 (severe) | 0.9 | Percentage of Patients | |
| Percent Change From Baseline in Intraocular Pressure (IOP) in the Study Eye of Treatment-Naive Patients | Bimatoprost 0.01% | -30.9 | Standard Deviation 15.4 | Percent Change | |
| Percent Change From Baseline in IOP in the Study Eye of Previously Treated (Switched) Patients | Bimatoprost 0.01% | -16.1 | Standard Deviation 18.8 | Percent Change | |
| Percent Change From Baseline in IOP in the Study Eye of Patients Treated With Adjunctive Therapy | Bimatoprost 0.01% | -16.1 | Standard Deviation 20.4 | Percent Change | |
| Change From Baseline in IOP in the Study Eye of Treatment-Naive Patients | Bimatoprost 0.01% | Baseline | 23.5 | Standard Deviation 5.8 | Millimeters of Mercury (mmHg) |
| Change From Baseline in IOP in the Study Eye of Treatment-Naive Patients | Bimatoprost 0.01% | Change from Baseline at Week 6 | -7.4 | Standard Deviation 4.9 | Millimeters of Mercury (mmHg) |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Bimatoprost 0.01% | 1,137 | |
| Overall Study | COMPLETED | Bimatoprost 0.01% | 997 | |
| Overall Study | NOT COMPLETED | Bimatoprost 0.01% | 140 |
Source ClinicalTrials.gov
Adverse events3
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 | Cerebrovascular Accident | Cardiac disorders | Bimatoprost 0.01% | 1 | 1,137 | |
| serious | Malaise | General disorders | Bimatoprost 0.01% | 1 | 1,137 | |
| serious | Myocardial Infarction | Cardiac disorders | Bimatoprost 0.01% | 1 | 1,137 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Bimatoprost 0.01% | ||
| Total, other adverse events | Bimatoprost 0.01% | 0 | 1,137 |
| Total, serious adverse events | Bimatoprost 0.01% | 3 | 1,137 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT01833741
GET https://conductscience.org/api/trials/v1/NCT01833741/results?page=2