Safety and Efficacy of a New Ophthalmic Formulation of Bimatoprost in Patients With Open Angle Glaucoma and Ocular Hypertension
Public ClinicalTrials.gov record NCT01157364. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
An Open-label (Stage 1) and Randomized (Stage 2), 24 Month Study of Safety and Efficacy of Bimatoprost Drug Delivery System in Patients With Open-Angle Glaucoma or Ocular Hypertension
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study will evaluate the safety and efficacy of new ophthalmic formulations of bimatoprost in patients with open angle glaucoma and ocular hypertension. At least 3 dose strengths will be evaluated based on internal data review of each cohort. The study was planned to be conducted in 2 stages. Stage 1 was an open-label and Stage 2 was planned to be masked; however only Stage 1 was conducted.
Study identification
- NCT ID
- NCT01157364
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 109 participants
Conditions and interventions
Conditions
Interventions
- bimatoprost 20 µg generation 2 Drug
- bimatoprost 15 µg generation 2 Drug
- bimatoprost 10 µg generation 2 Drug
- bimatoprost 6 µg generation 2 Drug
- bimatoprost 15 µg generation 1 Drug
- bimatoprost 10 µg generation 1 Drug
- bimatoprost 0.03% Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 23, 2010 (Actual)
- Primary completion
- Jul 27, 2016 (Actual)
- Completion
- Aug 9, 2016 (Actual)
- Last update posted
- Mar 30, 2020
2010 – 2016
United States locations
- U.S. sites
- 36
- U.S. states
- 16
- U.S. cities
- 34
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Sall Research Medical Center | Artesia | California | 90701 | — |
| Shiley Eye Center, Hamilton Glaucoma Center, University of California, San Diego | La Jolla | California | 92093 | — |
| Doheny Eye Institute | Los Angeles | California | 90033 | — |
| Martel Eye Medical Group | Rancho Cordova | California | 95670 | — |
| Shasta Eye Medical Group, Inc. | Redding | California | 96002 | — |
| Grutzmacher and Lewis, Inc. | Sacramento | California | 95815 | — |
| Pacific Eye Surgeons | San Luis Obispo | California | 93401 | — |
| Wolstan & Goldberg Eye Associates | Torrance | California | 90505 | — |
| Specialty Eye Care | Parker | Colorado | 80134 | — |
| The Eye Associates of Manatee | Bradenton | Florida | 34209 | — |
| Emory University, The Emory Eye Center | Atlanta | Georgia | 30322 | — |
| Coastal Research Associates | Roswell | Georgia | 30076 | — |
| Springfield Clinic | Springfield | Illinois | 62703 | — |
| Glaucoma Consultants | Baltimore | Maryland | 21204 | — |
| Tufts Medical Center/New England Eye Center | Boston | Massachusetts | 02111 | — |
| Ophthalmic Consultants of Boston | Boston | Massachusetts | 02114 | — |
| ActivMed Practices & Research | Methuen | Massachusetts | 01844 | — |
| Clinical Eye Research of Boston/ Charles River Eye Associates | Winchester | Massachusetts | 01890 | — |
| Moyes Eye Center | Kansas City | Missouri | 64154 | — |
| Northern New Jersey Eye Institute PA | South Orange | New Jersey | 07079 | — |
| Ophthalmic Consultants of Long Island | Lynbrook | New York | 11563 | — |
| Glaucoma Associates of NY | New York | New York | 10003 | — |
| Rochester Ophthalmological Group PC | Rochester | New York | 14618 | — |
| Charlotte Eye Ear Nose & Throat Associates, PA | Charlotte | North Carolina | 28210 | — |
| Cornerstone Eye Care | High Point | North Carolina | 27262 | — |
| James D. Branch, MD | Winston-Salem | North Carolina | 27101 | — |
| Legacy Good Samaritan - Devers Eye Institute | Portland | Oregon | 97210 | — |
| Scott & Christie and Associates | Cranberry Township | Pennsylvania | 16066 | — |
| Philadelphia Eye Associates | Philadelphia | Pennsylvania | 19148 | — |
| Keystone Research LTD | Austin | Texas | 78731 | — |
| Glaucoma Associates of TX | Dallas | Texas | 75231 | — |
| R and R Eye Research | San Antonio | Texas | 78229 | — |
| Medical Center Ophthalmology Associates | San Antonio | Texas | 78240 | — |
| Focus Clinical Research | Salt Lake City | Utah | 84107 | — |
| Spokane Eye Clinical Research | Spokane | Washington | 99204 | — |
| Wenatchee Valley Medical Center | Wenatchee | Washington | 98801 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 21 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01157364, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 30, 2020 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01157364 live on ClinicalTrials.gov.