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

Phase 1

Completed

• Conditions: Open-Angle Glaucoma; Ocular Hypertension
• Interventions: Drug: Fixed Combination; Drug: Timolol; Drug: Bimatoprost; Device: Placebo Segment; Drug: Timolol 0.5%

• Registration Number: NCT02742649
• Lead Sponsor: ForSight Vision5, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-04-06
• Study First Submitted QC: 2016-04-14
• Study First Posted: 2016-04-19
• Study Start: 2016-04-30
• Primary Completion: 2016-12-31
• Study Completion: 2016-12-31
• Results First Submitted: 2018-06-08
• Results First Submitted QC: 2018-06-08
• Results First Posted: 2018-12-31
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-07
• Last Update Posted: 2019-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fixed Combination (FC) Ocular Insert	Timolol 0.5%	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.
Timolol Ocular Insert	Timolol 0.5%	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.
Fixed Combination (FC) Ocular Insert	Fixed Combination	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.
Fixed Combination (FC) Ocular Insert	Placebo Segment	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.
Timolol Ocular Insert	Timolol	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.
Bimatoprost Ocular Insert	Timolol 0.5%	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.
Bimatoprost Ocular Insert	Placebo Segment	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.
Timolol Ocular Insert	Placebo Segment	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.
Bimatoprost Ocular Insert	Bimatoprost	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.

Primary Outcome Measures

Name	Time	Method
Intraocular Pressure (IOP) on Day 8	Day 8	IOP is a measurement of the fluid pressure inside the eye. IOP was measured at the following three time points: 8 am (T=0 hour), 12 pm (T=4 hour) and 4 pm (T=8 hour). The IOP measured in the two eyes was averaged to compute a single IOP value for each timepoint.
IOP on Day 16	Day 16	IOP is a measurement of the fluid pressure inside the eye. IOP was measured at the following three time points: 8 am (T=0 hour), 12 pm (T=4 hour) and 4 pm (T=8 hour). The IOP measured in the two eyes was averaged to compute a single IOP value for each timepoint.
IOP on Day 28	Day 28	IOP is a measurement of the fluid pressure inside the eye. IOP was measured at the following three time points: 8 am (T=0 hour), 12 pm (T=4 hour) and 4 pm (T=8 hour). The IOP measured in the two eyes was averaged to compute a single IOP value for each timepoint.
IOP on Day 49	Day 49	IOP is a measurement of the fluid pressure inside the eye. IOP was measured at the following three time points: 8 am (T=0 hour), 12 pm (T=4 hour) and 4 pm (T=8 hour). The IOP measured in the two eyes was averaged to compute a single IOP value for each timepoint.
IOP on Day 70	Day 70	IOP is a measurement of the fluid pressure inside the eye. IOP was measured at the following three time points: 8 am (T=0 hour), 12 pm (T=4 hour) and 4 pm (T=8 hour). The IOP measured in the two eyes was averaged to compute a single IOP value for each timepoint.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Ocular and Non-Ocular Adverse Events	From Randomization (Day 0) to Day 70	An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. Reported here is the number of participants with adverse events related to the eye as well as number of participants with all other adverse events.
IOP During Open Label Period	Day 98, Day 112	IOP is a measurement of the fluid pressure inside the eye. IOP was measured at the following three time points: 8 am (T=0 hour), 12 pm (T=4 hour) and 4 pm (T=8 hour) at the start (Day 98) and end (Day 112) of the Open Label Period during which participants were treated with timolol 0.5% ophthalmic solution twice daily. The IOP measured in the two eyes was averaged to compute a single IOP value for each timepoint.

Trial Locations

Locations (1)

Clinica de Ojos Orillac - Calvo; 🇵🇦 Panama City, Panama