An Open-label Extension Study to Evaluate the Safety of the 13 mg Bimatoprost Ocular Insert (OLE2)

ForSight Vision5

Status and phase: Completed; Phase 2

Conditions: Primary Open-Angle Glaucoma; Ocular Hypertension

Treatments: Drug: Bimatoprost

Study type: Interventional

Funder types: Industry

Identifiers

NCT02537015

FSV5-005 OLE 2

Details and patient eligibility

About

This study evaluated the long-term (9-months) safety of the Bimatoprost Ocular Insert in participants with Glaucoma or Ocular Hypertension who completed study FSV5-004. All the participants received Bimatoprost Ocular Insert and wore it for approximately 3 months (12 weeks), then had that Insert removed and a new Insert placed for another 26 weeks (approximately 6 months).

Enrollment: 81 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

1. Completed FSV5-004 study.
2. Written informed consent prior to any study procedure.
3. Willingness to comply with the visit schedule.

Key Exclusion Criteria:

1. Participation in an investigational drug or device study other than FSV5-004 within the past 6 months or anticipated participation during the study period.
2. Subjects who will require contact lens use during the study period.
3. Any condition or situation (such as uncontrolled systemic disease) that, in the Investigator's opinion, might confound the results of the study, may put the subject at significant risk or might interfere with the subject's ability to participate in the study.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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81 participants in 1 patient group

13 mg Bimatoprost Ocular Insert

Experimental group

Description:

13 mg Bimatoprost Ocular Insert in each eye used continuously for 12 weeks, then replaced with a new 13 mg Bimatoprost Ocular Insert in each eye used continuously for another 26 weeks.

Treatment:

Drug: Bimatoprost