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OpenTrials
Completed

NCT Number: NCT02358369

Dose-Ranging Study of the Bimatoprost Ocular Insert

The Bimatoprost Ocular Insert is intended to provide sustained delivery of bimatoprost to the ocular surface to lower the intraocular pressure (IOP) in patients with Open-Angle Glaucoma or Ocular Hypertension.

This study evaluated the safety and efficacy of two different doses of the Bimatoprost Ocular Insert, compared to an active control arm with timolol ophthalmic solution (0.5%).

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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

Vold Vision, Fayetteville, Arkansas, 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
  • 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:

("T" is defined as time and "hr" is defined as hour[s])

  • IOP for each eye is ≥ 23 mm Hg at T=0 hr, ≥ 20 mm Hg at T=2 hr and T=8 hr.
  • Inter-eye IOP difference of ≤ 5.0 mm Hg at T=0 hr, T=2 hr and T=8 hr.
  • IOP for each eye is ≤ 30 mm Hg at T=0 hr, T=2 hr and T=8 hr.

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 beta-blocker drops
  • 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 30 days of Screening
  • Inability to adequately evaluate the retina
  • Participants who will require contact lens use during the study period.
  • Participants 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

Bimatoprost

Drug

Bimatoprost sustained release Ocular Insert

Timolol 0.5%

Drug

BID drops OU, 0.5% ophthalmic solution

Placebo Ocular Insert

Device

Placebo ocular insert OU.

Placebo Eye Drops

Drug

Placebo eye drops BID OU.

Primary outcomes

  1. Change From Baseline in Intraocular Pressure (IOP) at Week 8

    Time frame: Baseline (Day 0) to Week 8

    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 8. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal timepoint. A negative change from Baseline indicated an improvement.

  2. Change From Baseline in 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 an improvement.

  3. Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at Week 8

    Time frame: Baseline (Day 0) to Week 8

    BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.

  4. Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at Week 12

    Time frame: Baseline (Day 0) to Week 12

    BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.

  5. Percentage of Participants With Clinically Significant Change From Baseline in Slit-Lamp Examination Findings at Week 12

    Time frame: Baseline (Day 0) to Week 12

    The clinician examined and graded the eyelids, conjunctiva, cornea and anterior chamber of the eye with the aid of a slit-lamp, (conjunctival erythema was assessed as part of the examination). Fluorescein dye was instilled into the ocular cul-de-sac to facilitate this examination.

  6. Change From Baseline in Automated Visual Field at Week 12

    Time frame: Baseline (Day 0) to Week 12

    Automated Visual Field was examined used the Humphrey Visual Field Analyzer, a test that measures the entire area of peripheral vision that can be seen while the eye is focused on a central point. A positive change from Baseline indicates improvement.

  7. Dilated Fundus Exam: Cup-to-Disc-Ratio

    Time frame: Week 12

    The cup-to-disk-ratio is an eye test to assess the progression of glaucoma. The diameter of the cup is compared to the diameter of the disk and a ratio is determined. The normal cup-disk ratio is 0.3. An increase in the cup-to-disc-ratio is a possible indication of glaucoma.

  8. Percentage of Participants by Dilated Fundus Exam Pathology Grade at Week 12

    Time frame: Week 12

    Dilated fundus examination pathology findings were noted, described and graded on a scale of None (0), Mild (+1), Moderate (+2) and Severe (+3). The percentage of participants in each grade is reported.

  9. Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity in Period A/B

    Time frame: Baseline (Day 0) to Week 12

    An AE was defined as any untoward medical occurrence (eg, sign, symptom, disease, syndrome, intercurrent illness) that occurred in a study participant, regardless of the suspected cause during the study. An ocular AE is an AE that occurred in the eye and non-ocular is an AE that occurred not in the eye. Th investigator assessed the worst severity of each AE as: Mild=aware of sign or symptom, but readily tolerated, Moderate=discomfort enough to cause interference with usual activity or Severe=incapacitating with inability to work or do usual activity.

  10. Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity in Period C

    Time frame: Week 12 to Week 24

    An AE was defined as any untoward medical occurrence (eg, sign, symptom, disease, syndrome, intercurrent illness) that occurred in a study participant, regardless of the suspected cause during the study. An ocular AE is an AE that occurred in the eye and non-ocular is an AE that occurred not in the eye. The investigator assessed the worst severity of each AE as: Mild=aware of sign or symptom, but readily tolerated, Moderate=discomfort enough to cause interference with usual activity or Severe=incapacitating with inability to work or do usual activity.

Secondary outcomes

  1. Change From Baseline in 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 (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 an improvement.

  2. Change From Baseline in 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 an improvement.

  3. Change From Baseline in IOP in Period C

    Time frame: Baseline (Day 0) to Weeks 14, 18 and 24

    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 Weeks 14, 18 and 24. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal timepoint. A negative change from Baseline indicated an improvement.

Sponsors and collaborators

Lead sponsor

ForSight Vision5, Inc.

Industry

Registry information

Official study title

A Phase 2 Prospective, Multicenter, Randomized, Double-masked, Controlled Study to Evaluate the Efficacy and Safety and Dose-response of the Bimatoprost Ocular Insert (2.2 mg, 13 mg) With and Without Concomitant Artificial Tears Compared to a Placebo Ocular Insert With and Without Concomitant Timolol (0.5%) Ophthalmic Solution in Patients With Open-angle Glaucoma or Ocular Hypertension

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Feb 9, 2015
Registry last updated
Jun 4, 2020

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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