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

NCT ID: NCT02742649

Last Updated: 2019-02-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2016-12-31

Brief Summary

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.

Conditions

Open-Angle Glaucoma; Ocular Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Fixed Combination (FC) Ocular Insert

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.

Group Type: EXPERIMENTAL

Fixed Combination

Intervention Type: DRUG

Continuous elution from the ocular insert.

Placebo Segment

Intervention Type: DEVICE

One segment of placebo (no drug product)

Timolol 0.5%

Intervention Type: DRUG

0.5% timolol drops twice daily.

Bimatoprost Ocular Insert

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.

Group Type: EXPERIMENTAL

Bimatoprost

Intervention Type: DRUG

Continuous elution from the ocular insert. This is an active control arm.

Placebo Segment

Intervention Type: DEVICE

One segment of placebo (no drug product)

Timolol 0.5%

Intervention Type: DRUG

0.5% timolol drops twice daily.

Timolol Ocular Insert

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.

Group Type: EXPERIMENTAL

Timolol

Intervention Type: DRUG

Continuous elution from the ocular insert. This is an active control arm.

Placebo Segment

Intervention Type: DEVICE

One segment of placebo (no drug product)

Timolol 0.5%

Intervention Type: DRUG

0.5% timolol drops twice daily.

Interventions

Fixed Combination

Continuous elution from the ocular insert.

Intervention Type: DRUG

Bimatoprost

Continuous elution from the ocular insert. This is an active control arm.

Intervention Type: DRUG

Timolol

Continuous elution from the ocular insert. This is an active control arm.

Intervention Type: DRUG

Placebo Segment

One segment of placebo (no drug product)

Intervention Type: DEVICE

Timolol 0.5%

0.5% timolol drops twice daily.

Intervention Type: DRUG

Other Intervention Names

Bimatoprost-Timolol combination; Bimatoprost component only; Timolol component only

Eligibility Criteria

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

• 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.

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ForSight Vision5, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michelle Chen, PhD

Role: STUDY_DIRECTOR

Allergan

Locations

Clinica de Ojos Orillac - Calvo

Panama City, , Panama

Countries

Panama

Other Identifiers

FSV5-FC-001

Identifier Type: -

Identifier Source: org_study_id