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

Glaucoma Clinical Trial

Official title:

A Prospective, Multicenter, Randomized, Double-Masked, Multi-Arm Feasibility Study Evaluating the Safety and Efficacy of OTX-TP Compared to Timolol Drops in the Treatment of Subjects With Open Angle Glaucoma or Ocular Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01845038
• Other study ID #: OTX-12-003
• Status: Completed
• Phase: Phase 1
• First received: April 18, 2013
• Last updated: December 8, 2016
• Start date: April 2013
• Est. completion date: May 2014

Study information

• Verified date: December 2014
• Source: Ocular Therapeutix, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Africa: Medicines Control Council
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: May 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle

Intervention

Drug:
• OTX-TPa ~4µg/day over 2 mos. with natural tears drops
OTX-TPa is a hydrogel punctum plug eluting travoprost in a sustained release of ~4µg/day over 2 months. Subjects in this arm will also receive natural tears drops.
• OTX-TPb ~3µg/day over 3 months with natural tears drops
OTX-TPb is a hydrogel punctum plug eluting travoprost in a sustained release of ~3µg/day over 3 months. Subjects in this arm will also receive natural tears drops.
• Timolol Maleate (0.5%) dosed twice daily with punctum plug without drug
Timolol Maleate (0.5%) ophthalmic solution dosed twice daily. Subjects in this arm will also have a hydrogel punctum plug without drug placed.

Locations

Country	Name	City	State
South Africa	Umhlanga Hospital Medical Centre	Durban

Sponsors (1)

Lead Sponsor	Collaborator
Ocular Therapeutix, Inc.

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Best corrected visual acuity		90 days	Yes
Primary	Mean IOP change from baseline		90 days	No
Secondary	Visualization of OTX-TP punctum plug by subject	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.	90 days	No