Phase 2 Completed N=169 Randomized Triple-blind Treatment

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

Open-angle glaucoma · Hypertension

Source: ClinicalTrials.gov NCT01915940 ↗

Enrolled (actual)

169

Serious AEs

2.3%

Results posted

Apr 2018

Primary outcomePrimary: Change From Baseline in Intra-Ocular Pressure (IOP) at Week 2 — 24.99; 25.34; 23.65; 23.75 mm Hg

Summary

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Intra-Ocular Pressure (IOP) at Week 2	24.99; 25.34; 23.65; 23.75; 22.95; 23.16	—
PRIMARY Change From Baseline in Intra-Ocular Pressure (IOP) at Week 6	24.99; 25.34; 23.65; 23.75; 22.95; 23.16	—
PRIMARY Change From Baseline in Intra-Ocular Pressure (IOP) at Week 12	24.99; 25.34; 23.65; 23.75; 22.95; 23.16	—
SECONDARY Change From Baseline in IOP at Month 4	24.99; 25.34; 23.65; 23.75; 22.95; 23.16	—
SECONDARY Change From Baseline in IOP at Month 5	24.99; 25.34; 23.65; 23.75; 22.95; 23.16	—
SECONDARY Change From Baseline in IOP at Month 6	24.99; 25.34; 23.65; 23.75; 22.95; 23.16	—

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01915940). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.