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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-10

Study Completion Date

2016-08-11

Brief Summary

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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).

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Detailed Description

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Conditions

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Primary Open-Angle Glaucoma Ocular Hypertension

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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13 mg Bimatoprost Ocular Insert

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.

Group Type EXPERIMENTAL

Bimatoprost

Intervention Type DRUG

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

Interventions

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Bimatoprost

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

Intervention Type DRUG

Other Intervention Names

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"Lumigan" is the branded name of bimatoprost in eye drop form

Eligibility Criteria

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Inclusion Criteria

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

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No