A Study to Evaluate Efficacy and Safety of a Fixed Combination Ocular Insert in Participants With Open-angle Glaucoma or Ocular Hypertension

ForSight Vision5

Status and phase: Completed; Phase 2; Phase 1

Conditions: Open-Angle Glaucoma; Ocular Hypertension

Treatments: Drug: Fixed Combination; Drug: Timolol; Device: Placebo Segment; Drug: Bimatoprost; Drug: Timolol 0.5%

Study type: Interventional

Funder types: Industry

Identifiers

NCT02742649

FSV5-FC-001

Details and patient eligibility

About

The purpose of this study is to determine if a combination of two drugs (bimatoprost and timolol) delivered to the surface of the eye over 10 weeks is better at lowering intraocular pressure (IOP) than either of the drugs delivered alone.

Enrollment: 55 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Written informed consent
• At least 18 years of age
• Diagnosis in both eyes of either primary open-angle glaucoma (POAG) or ocular hypertension
• Best corrected-distance visual acuity score equivalent to 20/80 or better
• Stable visual field
• Central corneal thickness between 490 - 620 micrometers

Inclusion Criteria at the Randomization Visit:

• IOP for each eye is ≥ 23 mmHg at T=0hr, ≥ 20 mmHg at T=4hr and T=8hr.
• Inter-eye IOP difference of ≤ 5.0 mmHg at T=0hr, T=4hr and T=8hr.
• IOP for each eye is ≤ 30 mmHg at T=0hr, T=4hr and T=8hr.

Key Exclusion Criteria:

• Any known contraindication to prostaglandin analog (latanoprost, travoprost, bimatoprost, tafluprost) or timolol
• A cardiac or pulmonary condition that in the opinion of the Investigator would contraindicate the use of a topical beta-blocker
• Use of any agents known to have a substantial effect on IOP during planned study period (e.g. beta-blockers)
• Cup-to-disc ratio of greater than 0.8
• Significant risk of angle closure due to pupil dilation, defined as a Shaffer classification of less than Grade 2 based on gonioscopy
• Ocular, orbital, and/or eyelid surgery of any type within the past six (6) months from screening date
• Laser surgery for glaucoma / ocular hypertension on one (1) or both eyes within the last six (6) months
• Past history of any incisional surgery for glaucoma at any time
• Past history of corneal refractive surgery
• Corneal abnormalities that would interfere with accurate IOP readings with an applanation tonometer
• Current participation in an investigational drug or device study or participation in such a study within 7 days of Screening
• Inability to adequately evaluate the retina
• Subjects who will require contact lens use during the study period.
• Subjects who currently have punctal occlusion
• Pregnant, lactating or of child-bearing potential and not using a medically acceptable form of birth control

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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55 participants in 3 patient groups

Fixed Combination (FC) Ocular Insert

Experimental group

Description:

Washout plus Placebo Ocular Insert in each eye for 24 to 48 days, followed by one segment of bimatoprost and one segment of timolol maleate combined onto a single ocular insert in each eye for 70 days. Following a second washout period, 0.5% timolol drops twice daily in each eye from Day 99 to 112.

Treatment:

Device: Placebo Segment

Drug: Timolol 0.5%

Drug: Fixed Combination

Bimatoprost Ocular Insert

Experimental group

Description:

Washout plus Placebo Ocular Insert in each eye for 24 to 48 days, followed by one segment of bimatoprost and one placebo segment (no drug product) combined onto a single ocular insert in each eye for 70 days. Following a second washout period, 0.5% timolol drops twice daily in each eye from Day 99 to 112.

Treatment:

Drug: Bimatoprost

Device: Placebo Segment

Drug: Timolol 0.5%

Timolol Ocular Insert

Experimental group

Description:

Washout plus Placebo Ocular Insert in each eye for 24 to 48 days, followed by one segment of timolol and one placebo segment (no drug product) combined onto a single ocular insert in each eye for 70 days. Following a second washout period, 0.5% timolol drops twice daily in each eye from Day 99 to 112.

Treatment:

Device: Placebo Segment

Drug: Timolol 0.5%

Drug: Timolol