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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02742649
• Date of registration: 06/04/2016
• Prospective Registration: Yes
• Primary sponsor: ForSight Vision5, Inc.
• Public title: A Study to Evaluate Efficacy and Safety of a Fixed Combination Ocular Insert in Participants With Open-angle Glaucoma or Ocular Hypertension
• Scientific title: A Phase 1B, Multicenter, Randomized, Double-masked, Controlled Study to Evaluate the Efficacy and Safety of a Fixed Combination Bimatoprost/Timolol Ocular Insert Compared to Its Individual Components With Crossover to Timolol 0.5% in Subjects With Open-angle Glaucoma (OAG) or Ocular Hypertension (OHT)
• Date of first enrolment: April 30, 2016
• Target sample size: 55
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02742649
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 1/Phase 2

Countries of recruitment

Panama

Contacts

• Name: Michelle Chen, PhD
• Affiliation: Allergan

Key inclusion & 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Open-Angle Glaucoma

Ocular Hypertension

Intervention(s)

Drug: Fixed Combination

Drug: Timolol

Device: Placebo Segment

Drug: Bimatoprost

Drug: Timolol 0.5%

Primary Outcome(s)

IOP on Day 70 [Time Frame: Day 70]

IOP on Day 16 [Time Frame: Day 16]

IOP on Day 49 [Time Frame: Day 49]

IOP on Day 28 [Time Frame: Day 28]

Intraocular Pressure (IOP) on Day 8 [Time Frame: Day 8]

Secondary Outcome(s)

IOP During Open Label Period [Time Frame: Day 98, Day 112]

Number of Participants With Ocular and Non-Ocular Adverse Events [Time Frame: From Randomization (Day 0) to Day 70]

Secondary ID(s)

FSV5-FC-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 31/12/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02742649