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

AbbVie

Status and phase: Completed; Phase 3

Conditions: Open-Angle Glaucoma; Ocular Hypertension

Treatments: Drug: LUMIGAN; Drug: Bimatoprost SR

Study type: Interventional

Funder types: Industry

Identifiers

NCT04285580

1698-304-007

Details and patient eligibility

About

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

Enrollment: 37 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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37 participants in 2 patient groups

Bimatoprost SR 10 μg

Experimental group

Description:

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.

Treatment:

Drug: Bimatoprost SR

LUMIGAN 0.01%

Other group

Description:

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.

Treatment:

Drug: LUMIGAN