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OpenTrials
Completed

NCT Number: NCT01915940

Bimatoprost Ocular Insert Compared to Topical Timolol Solution in Patients With Glaucoma or Ocular Hypertension

The objective of this Phase 2 study is to evaluate whether the Bimatoprost Ocular Insert is non-inferior to that of timolol ophthalmic solution (0.5%) at 12 weeks.

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Key information

Conditions

Primary 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 2

Primary location

Sall Medical Research Center, Artesia, California, United States

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Who can participate

Healthy volunteers accepted: No

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

Key Inclusion Criteria:

  • Written informed consent
  • Primary open-angle glaucoma or ocular hypertension in both eyes
  • Best-corrected distance vision of 20/80 or better
  • Stable visual field
  • corneal thickness between 490-620 micrometers

Key Exclusion Criteria:

  • Cup-to-disc ratio 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
  • laser surgery for glaucoma/ocular hypertension on one or both eyes within the last 12 months
  • past history of corneal refractive surgery
  • past history of any incisional surgery for glaucoma at any time
  • corneal abnormalities that would interfere with tonometry readings
  • current participation in an investigational drug or device study or participation in such a study within 30 days of screening
  • Inability to accurately evaluate the retina

Treatment and study plan

Bimatoprost

Drug

Bimatoprost ocular insert

Timolol 0.5%

Drug

Timolol 0.5% solution

Other names: timoptic

Placebo Eye Drops

Drug

Placebo topical eye drops

Placebo Ocular Insert

Device

Ocular insert without any active drug

Other names: non-medicated (placebo) Ocular Insert

Primary outcomes

  1. Change From Baseline in Intra-Ocular Pressure (IOP) at Week 2

    Time frame: Baseline (Day 0) to Week 2

    IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP measurements were taken at 8 am (time (T)=0 hour), 10 am (T=2 hour), and 4 pm (T=8 hour) at Week 2. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal timepoint. A negative change from Baseline indicated improvement.

  2. Change From Baseline in Intra-Ocular Pressure (IOP) at Week 6

    Time frame: Baseline (Day 0) to Week 6

    IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP measurements were taken at 8 am (T=0 hour), 10 am (T=2 hour), and 4 pm (T=8 hour) at Week 6. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal timepoint. A negative change from Baseline indicated improvement.

  3. Change From Baseline in Intra-Ocular Pressure (IOP) at Week 12

    Time frame: Baseline (Day 0) to Week 12

    IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP measurements were taken at 8 am (T=0 hour), 10 am (T=2 hour), and 4 pm (T=8 hour) at Week 12. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal timepoint. A negative change from Baseline indicated improvement.

Secondary outcomes

  1. Change From Baseline in IOP at Month 4

    Time frame: Baseline (Day 1) to Month 4

    IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP measurements were taken at 8 am (T=0 hour), 10 am (T=2 hour), and 4 pm (T=8 hour) at Month 4. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal timepoint. A negative change from Baseline indicated improvement.

  2. Change From Baseline in IOP at Month 5

    Time frame: Baseline (Day 0) to Month 5

    IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP measurements were taken at 8 am (T=0 hour), 10 am (T=2 hour), and 4 pm (T=8 hour) at Month 5. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal timepoint. A negative change from Baseline indicated improvement.

  3. Change From Baseline in IOP at Month 6

    Time frame: Baseline (Day 0) to Month 6

    IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP measurements were taken at 8 am (T=0 hour), 10 am (T=2 hour), and 4 pm (T=8 hour) at Month 6. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal timepoint. A negative change from Baseline indicated improvement.

Sponsors and collaborators

Lead sponsor

ForSight Vision5, Inc.

Industry

Registry information

Official study title

A Phase 2, Multicenter, Randomized, Subject- and Examiner-masked, Controlled Clinical Trial Designed to Evaluate the Safety and Effectiveness of the Bimatoprost Ocular Insert as Compared to Topical Timolol Solution (0.5%) in Patients With Glaucoma or Ocular Hypertension.

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Aug 5, 2013
Registry last updated
Apr 20, 2018

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.

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