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

NCT02742649 | Completed Phase 1 Results

• 1 other identifier: FSV5-FC-001
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (5)

• Intraocular Pressure (IOP) on 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.

  Day 8

• IOP on 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.

  Day 16

• IOP on 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.

  Day 28

• IOP on 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.

  Day 49

• IOP on 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.

  Day 70

Secondary Outcomes (2)

• Number of Participants With Ocular and Non-Ocular Adverse Events

  From Randomization (Day 0) to Day 70

• IOP During Open Label Period

  Day 98, Day 112

Study Arms (3)

Fixed Combination (FC) Ocular Insert

EXPERIMENTAL

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.

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

Bimatoprost Ocular Insert

EXPERIMENTAL

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.

Drug: Bimatoprost; Device: Placebo Segment; Drug: Timolol 0.5%

Timolol Ocular Insert

EXPERIMENTAL

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.

Drug: Timolol; Device: Placebo Segment; Drug: Timolol 0.5%

Interventions

Fixed Combination DRUG

Continuous elution from the ocular insert.

Also known as: Bimatoprost-Timolol combination

Fixed Combination (FC) Ocular Insert

Bimatoprost DRUG

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

Also known as: Bimatoprost component only

Bimatoprost Ocular Insert

Timolol DRUG

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

Also known as: Timolol component only

Timolol Ocular Insert

Placebo Segment DEVICE

One segment of placebo (no drug product)

Bimatoprost Ocular Insert; Fixed Combination (FC) Ocular Insert; Timolol Ocular Insert

Timolol 0.5% DRUG

0.5% timolol drops twice daily.

Bimatoprost Ocular Insert; Fixed Combination (FC) Ocular Insert; Timolol Ocular Insert

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• ForSight Vision5, Inc.: lead

Study Sites (1)

Clinica de Ojos Orillac - Calvo

Panama City, Panama

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Interventions

Bimatoprost; Timolol

Condition Hierarchy (Ancestors)

Glaucoma; Eye Diseases

Intervention Hierarchy (Ancestors)

Amides; Organic Chemicals; Cloprostenol; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Propanolamines; Amino Alcohols; Alcohols; Propanols; Amines; Thiadiazoles; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morpholines; Oxazines

Results Point of Contact

• Title: Therapeutic Area Head,
• Organization: Allergan, Inc

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Michelle Chen, PhD

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2016
• First Posted: April 19, 2016
• Study Start: April 30, 2016
• Primary Completion: December 31, 2016
• Study Completion: December 31, 2016
• Last Updated: February 25, 2019
• Results First Posted: December 31, 2018

Record last verified: 2019-02

Locations

PA (1)