A Phase 3b Study Evaluating the 24-Hour Intraocular Pressure Lowering Effect of Bimatoprost SR in Patients With Open-Angle Glaucoma or Ocular Hypertension

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-11

Study Completion Date

2022-05-14

Brief Summary

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This study will evaluate the 24-hour intraocular pressure lowering effect and safety after a single administration of Bimatoprost SR in patients with Open-Angle Glaucoma or Ocular Hypertension

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Detailed Description

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Conditions

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Open-Angle Glaucoma Ocular Hypertension

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Bimatoprost SR 10 μg

Participants will receive Bimatoprost SR 10 μg implant in the study eye on Day 1 and standard of care treatment in the fellow eye for the duration of the study.

Group Type EXPERIMENTAL

Bimatoprost SR

Intervention Type DRUG

Consists of 1 Bimatoprost SR administration in the study eye.

LUMIGAN 0.01%

Participants will receive topical LUMIGAN 0.01% in the study eye once daily starting evening Dose on Day 1 and standard of care treatment in the fellow eye for the duration of the study.

Group Type OTHER

LUMIGAN

Intervention Type DRUG

Treatment with LUMIGAN 0.01% begins on Day 1. The drop will be instilled once daily in the evening to the study eye throughout the duration of the study.

Interventions

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Bimatoprost SR

Consists of 1 Bimatoprost SR administration in the study eye.

Intervention Type DRUG

LUMIGAN

Treatment with LUMIGAN 0.01% begins on Day 1. The drop will be instilled once daily in the evening to the study eye throughout the duration of the study.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of either OAG or OHT study eye, requiring IOP-lowering treatment
* Participant is currently a nonsmoker and has not smoked any nicotine-containing products within the previous 6 months

Exclusion Criteria

* Current or anticipated enrollment in another investigational drug or device study
* Females who are pregnant, nursing, or planning a pregnancy during the study

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No