Clinical trial NCT02742649: A Study to Evaluate Efficacy and Safety of a Fixed Combination Ocular Insert in Participants With Open-angle Glaucoma or Ocular Hypertension
Official 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Open-Angle Glaucoma
Ocular Hypertension
Lead sponsor: ForSight Vision5, Inc.
Sponsor class: INDUSTRY
First posted: 2016-04-19
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Intraocular Pressure (IOP) on Day 8
timeFrame: Day 8
measure: IOP on Day 16
timeFrame: Day 16
measure: IOP on Day 28
timeFrame: Day 28
measure: IOP on Day 49
timeFrame: Day 49
measure: IOP on Day 70
timeFrame: Day 70
Secondary outcomes:
measure: Number of Participants With Ocular and Non-Ocular Adverse Events
timeFrame: From Randomization (Day 0) to Day 70
measure: IOP During Open Label Period
timeFrame: Day 98, Day 112
Other outcomes:
Locations:
city: Panama City
country: Panama
facility: Clinica de Ojos Orillac - Calvo
Study officials:
affiliation: Allergan
name: Michelle Chen, PhD
role: STUDY_DIRECTOR
References: