Multi-Arm Feasibility Study Evaluating OTX-TP Compared to Timolol in Treatment of Subjects With Open Angle Glaucoma

Phase 1

Completed

• Conditions: Glaucoma
• Interventions: Drug: OTX-TPb ~3µg/day over 3 months with natural tears drops; Drug: Timolol Maleate (0.5%) dosed twice daily with punctum plug without drug; Drug: OTX-TPa ~4µg/day over 2 mos. with natural tears drops

• Registration Number: NCT01845038
• Lead Sponsor: Ocular Therapeutix, Inc.

Brief Summary

The purpose of this study is to evaluate how OTX-TP, a sustained release travoprost drug product, when placed in the canaliculus of the eyelid compares to timolol drops for the lowering of intraocular pressure (IOP) in patients with open angle glaucoma or ocular hypertension.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-04-18
• Study First Submitted QC: 2013-04-29
• Study First Posted: 2013-05-03
• Primary Completion: 2014-03
• Study Completion: 2014-05
• Status Verified: 2014-12
• Last Update Submitted: 2016-12-08
• Last Update Posted: 2016-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

• Subject must be greater than or equal to 18 years of age at Screening.
• Subject must have a documented diagnosis of ocular hypertension, open angle glaucoma.
• Subject has a mean baseline (Day -7 and Day 0) Hour 0 (T0) untreated IOP of ≥ 24 mm Hg and ≤ 34 mm Hg in each eye, and (T0 + 4h) and (T0 + 8h) IOP of ≥ 22 mm Hg at Baseline Visit 2. Untreated IOP must be ≤ 34 mm Hg in each eye at all time points at both baseline visits.
• Subject has a BCVA of 0.6 logMAR (20/80 Snellen) or better in each eye as measured using an ETDRS chart.

Exclusion Criteria

• Presence of any uncontrolled systemic or debilitating disease (e.g. cardiovascular disease, hypertension, diabetes, or cystic fibrosis).
• Punctum size is smaller than 0.4mm or greater than or equal to 1.0mm.
• Any single IOP in either eye at any time point during the Screening or either Baseline (Day -7/Day 0) Visits of >34 mm Hg.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OTX-TPb	OTX-TPb ~3µg/day over 3 months with natural tears drops	OTX-TPb is a hydrogel punctum plug eluting travoprost in sustained release of \~3µg/day over approximately 3 months. For study masking purposes, subjects in this arm will also have natural tears drops administered.
Timolol	Timolol Maleate (0.5%) dosed twice daily with punctum plug without drug	Timolol Maleate (0.5%) ophthalmic solution dosed twice daily (BID). For study masking purposes, subjects in this arm will also have a hydrogel punctum plug with no drug placed for approximately 3 months.
OTX-TPa	OTX-TPa ~4µg/day over 2 mos. with natural tears drops	OTX-TPa is a hydrogel punctum plug eluting travoprost in sustained release of \~4µg/day over approximately 2 months. For study masking purposes, subjects in this arm will also have natural tears drops administered.

Primary Outcome Measures

Name	Time	Method
Mean IOP change from baseline	90 days

Secondary Outcome Measures

Name	Time	Method
Visualization of OTX-TP punctum plug by subject	90 days	OTX-TP punctum plug contains conjugated fluorescein to serve as a visualization aid through use of a blue light source and yellow filter to confirm product presence daily by subject for 90 days.

Trial Locations

Locations (1)

Umhlanga Hospital Medical Centre; 🇿🇦 Durban, South Africa