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

Ocular Therapeutix

Status and phase: Completed; Phase 1

Conditions: Glaucoma

Treatments: 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; Drug: OTX-TPb ~3µg/day over 3 months with natural tears drops

Study type: Interventional

Funder types: Industry

Identifiers

NCT01845038

OTX-12-003

Details and patient eligibility

About

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.

Enrollment: 41 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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41 participants in 3 patient groups

OTX-TPa

Experimental group

Description:

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.

Treatment:

Drug: OTX-TPa ~4µg/day over 2 mos. with natural tears drops

OTX-TPb

Experimental group

Description:

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.

Treatment:

Drug: OTX-TPb ~3µg/day over 3 months with natural tears drops

Timolol

Active Comparator group

Description:

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.

Treatment:

Drug: Timolol Maleate (0.5%) dosed twice daily with punctum plug without drug