Skip to main content
OpenTrials
Completed

NCT Number: NCT02742649

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Open-angle Glaucoma Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Clinica de Ojos Orillac - Calvo

Panama City, Panama

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fixed Combination

Drug

Continuous elution from the ocular insert.

Other names: Bimatoprost-Timolol combination

Bimatoprost

Drug

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

Other names: Bimatoprost component only

Timolol

Drug

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

Other names: Timolol component only

Placebo Segment

Device

One segment of placebo (no drug product)

Timolol 0.5%

Drug

0.5% timolol drops twice daily.

Primary outcomes

  1. Intraocular Pressure (IOP) on Day 8

    Time frame: 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.

  2. IOP on Day 16

    Time frame: 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.

  3. IOP on Day 28

    Time frame: 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.

  4. IOP on Day 49

    Time frame: 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.

  5. IOP on Day 70

    Time frame: 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 outcomes

  1. Number of Participants With Ocular and Non-Ocular Adverse Events

    Time frame: 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.

  2. IOP During Open Label Period

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

ForSight Vision5, Inc.

Industry

Registry information

Official study 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)

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Apr 19, 2016
Registry last updated
Feb 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.