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

Ocular Hypertension Clinical Trial

Official 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02742649
• Other study ID #: FSV5-FC-001
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: April 30, 2016
• Est. completion date: December 31, 2016

Study information

• Verified date: February 2019
• Source: ForSight Vision5, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: December 31, 2016
• Est. primary completion date: December 31, 2016
• 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:

• 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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Fixed Combination
Continuous elution from the ocular insert.
• Bimatoprost
Continuous elution from the ocular insert. This is an active control arm.
• Timolol
Continuous elution from the ocular insert. This is an active control arm.

Device:
• Placebo Segment
One segment of placebo (no drug product)

Drug:
• Timolol 0.5%
0.5% timolol drops twice daily.

Locations

Country	Name	City	State
Panama	Clinica de Ojos Orillac - Calvo	Panama City

Sponsors (1)

Lead Sponsor	Collaborator
ForSight Vision5, Inc.

Country where clinical trial is conducted

Panama, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Number of Participants With Ocular and Non-Ocular Adverse Events	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.	From Randomization (Day 0) to Day 70
Secondary	IOP During Open Label Period	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.	Day 98, Day 112