---
title: An Efficacy and Safety Study of Bimatoprost 0.01% Alone Compared With Travoprost 0.004% and Timolol 0.5% in Subjects With Glaucoma or Ocular Hypertension
nct_id: NCT01881126
overall_status: COMPLETED
phase: PHASE4
sponsor: Allergan
study_type: INTERVENTIONAL
primary_condition: Glaucoma
countries: Canada
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01881126.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01881126"
ct_last_update_post_date: 2015-11-30
last_seen_at: "2026-05-12T06:45:16.585Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# An Efficacy and Safety Study of Bimatoprost 0.01% Alone Compared With Travoprost 0.004% and Timolol 0.5% in Subjects With Glaucoma or Ocular Hypertension

**NCT ID:** [NCT01881126](https://clinicaltrials.gov/study/NCT01881126)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE4
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 93
- **Lead Sponsor:** Allergan
- **Conditions:** Glaucoma, Ocular Hypertension
- **Start Date:** 2013-06
- **Completion Date:** 2014-10
- **CT.gov Last Update:** 2015-11-30

## Brief Summary

This efficacy and safety study will evaluate LUMIGAN® RC/ LUMIGAN® .01 (bimatoprost 0.01%) alone compared to TRAVATAN Z® (travoprost 0.004%) and TIMOLOL MALEATE-EX, 0.5%/TIMOLOL GFS 0.5% (timolol 0.5% ophthalmic gel forming solution) in patients who require IOP lowering therapy.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Ocular hypertension or glaucoma that requires treatment with medication
* Have a best corrected visual acuity (BCVA) of 20/100 or better in both eyes

Exclusion Criteria:

* History of LASIK, LASEK, RK, and/or PRK in the study eye(s)
* History of any intraocular surgery or glaucoma laser surgery in the study eye(s) within 3 months
* Use of topical, periorbital, intravitreal or systemic steroid within 3 months or expected use during the course of study
```

## Arms

- **bimatoprost 0.01% and hypromellose 0.3%** (ACTIVE_COMPARATOR) — Bimatoprost 0.01% and hypromellose 0.3% lubricant eye drops (for masking purposes) each administered to both eyes once daily for 12 weeks.
- **travatan 0.004% and timolol 0.5%** (ACTIVE_COMPARATOR) — Travatan 0.004% and timolol 0.5% each administered to both eyes once daily for 12 weeks.

## Interventions

- **bimatoprost 0.01%** (DRUG) — Bimatoprost 0.01% administered to both eyes once daily for 12 weeks.
- **travatan 0.004%** (DRUG) — Travatan 0.004% administered to both eyes once daily for 12 weeks.
- **timolol 0.5%** (DRUG) — Timolol 0.5% administered to both eyes once daily for 12 weeks.
- **hypromellose 0.3%** (DRUG) — Hypromellose 0.3% lubricant eye drops (for masking purposes) administered to both eyes once daily for 12 weeks.

## Primary Outcomes

- **Intraocular Pressure (IOP) in the Study Eye at 8 AM, 12 PM, and 4 PM** _(time frame: Week 12 at 8 AM, 12 PM, and 4 PM)_ — IOP is a measurement of the fluid pressure inside the eye. IOP of the study eye (worse eye) is measured at 8 AM, 12 PM, and 4 PM. IOP is either the average of 2 measurements, or, if a third measurement is required, the average of 3 measurements.

## Locations (2)

- Barrie, Ontario, Canada
- Toronto, Ontario, Canada

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.|barrie|ontario|canada` — added _(2026-05-12)_
- `locations.|toronto|ontario|canada` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01881126.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01881126*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*