Dose-Ranging Study of the Bimatoprost Ocular Insert

Ocular Hypertension Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02358369
• Other study ID #: FSV5-004
• Status: Completed
• Phase: Phase 2
• Start date: January 19, 2015
• Est. completion date: October 7, 2015

Study information

• Verified date: May 2020
• Source: ForSight Vision5, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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%).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: October 7, 2015
• Est. primary completion date: August 31, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension
• Primary Open-Angle Glaucoma

Intervention

Drug:
• Bimatoprost
Bimatoprost sustained release Ocular Insert
• Timolol 0.5%
BID drops OU, 0.5% ophthalmic solution

Device:
• Placebo Ocular Insert
Placebo ocular insert OU.

Drug:
• Placebo Eye Drops
Placebo eye drops BID OU.

Locations

Country	Name	City	State
United States	Sall Medical Research Center	Artesia	California
United States	Mundorf Eye Center	Charlotte	North Carolina
United States	Vold Vision	Fayetteville	Arkansas
United States	Cornerstone Health Care	High Point	North Carolina
United States	Apex Eye	Madeira	Ohio
United States	University of Eye Specialists	Maryville	Tennessee
United States	Total Eye Care	Memphis	Tennessee
United States	Clayton Eye Center	Morrow	Georgia
United States	Eye Research Foundation	Newport Beach	California
United States	R&R Eye Research, LLC	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
ForSight Vision5, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Intraocular Pressure (IOP) at 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.	Baseline (Day 0) to Week 8
Primary	Change From Baseline in IOP at 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.	Baseline (Day 0) to Week 12
Primary	Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at 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.	Baseline (Day 0) to Week 8
Primary	Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at 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.	Baseline (Day 0) to Week 12
Primary	Percentage of Participants With Clinically Significant Change From Baseline in Slit-Lamp Examination Findings at 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.	Baseline (Day 0) to Week 12
Primary	Change From Baseline in Automated Visual Field at 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.	Baseline (Day 0) to Week 12
Primary	Dilated Fundus Exam: Cup-to-Disc-Ratio	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.	Week 12
Primary	Percentage of Participants by Dilated Fundus Exam Pathology Grade at 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.	Week 12
Primary	Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity in Period A/B	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.	Baseline (Day 0) to Week 12
Primary	Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity in Period C	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.	Week 12 to Week 24
Secondary	Change From Baseline in IOP at 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.	Baseline (Day 0) to Week 2
Secondary	Change From Baseline in IOP at 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.	Baseline (Day 0) to Week 6
Secondary	Change From Baseline in IOP in Period C	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.	Baseline (Day 0) to Weeks 14, 18 and 24