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

NCT01845038 | Completed Phase 1

• 1 other identifier: OTX-12-003
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Glaucoma

Outcome Measures

Primary Outcomes (1)

• Mean IOP change from baseline

  90 days

Secondary Outcomes (1)

• Visualization of OTX-TP punctum plug by subject

  90 days

Other Outcomes (1)

• Best corrected visual acuity

  90 days

Study Arms (3)

OTX-TPa

EXPERIMENTAL

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.

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

OTX-TPb

EXPERIMENTAL

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.

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

Timolol

ACTIVE COMPARATOR

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.

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

Interventions

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

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-TPa

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

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.

OTX-TPb

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

Timolol Maleate (0.5%) ophthalmic solution dosed twice daily. Subjects in this arm will also have a hydrogel punctum plug without drug placed.

Timolol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ocular Therapeutix, Inc.: lead

Study Sites (1)

Umhlanga Hospital Medical Centre

Durban, South Africa

Location

MeSH Terms

Conditions

Glaucoma

Interventions

Timolol; Pharmaceutical Preparations

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Thiadiazoles; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morpholines; Oxazines

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2013
• First Posted: May 3, 2013
• Study Start: April 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: May 1, 2014
• Last Updated: December 12, 2016

Record last verified: 2014-12

Locations

ZA (1)