Back to resultsMulti-Arm Feasibility Study Evaluating OTX-TP Compared to Timolol in Treatment of Subjects With Open Angle Glaucoma
Primary Purpose
Glaucoma
Status
Completed
Phase
Phase 1
Locations
South Africa
Study Type
Interventional
Intervention
OTX-TPa ~4µg/day over 2 mos. with natural tears drops
OTX-TPb ~3µg/day over 3 months with natural tears drops
Timolol Maleate (0.5%) dosed twice daily with punctum plug without drug
Sponsored by
About this trial
This is an interventional treatment trial for Glaucoma
Eligibility Criteria
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.
Sites / Locations
- Umhlanga Hospital Medical Centre
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
OTX-TPa
OTX-TPb
Timolol
Arm 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.
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 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.
Outcomes
Primary Outcome Measures
Mean IOP change from baseline
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01845038
First Posted
April 18, 2013
Last Updated
December 8, 2016
Sponsor
Ocular Therapeutix, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01845038
Brief Title
Multi-Arm Feasibility Study Evaluating OTX-TP Compared to Timolol in Treatment of Subjects With Open Angle Glaucoma
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
May 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ocular Therapeutix, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
OTX-TPa
Arm Type
Experimental
Arm 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.
Arm Title
OTX-TPb
Arm Type
Experimental
Arm 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.
Arm Title
Timolol
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
OTX-TPa ~4µg/day over 2 mos. with natural tears drops
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
OTX-TPb ~3µg/day over 3 months with natural tears drops
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Timolol Maleate (0.5%) dosed twice daily with punctum plug without drug
Intervention Description
Timolol Maleate (0.5%) ophthalmic solution dosed twice daily. Subjects in this arm will also have a hydrogel punctum plug without drug placed.
Primary Outcome Measure Information:
Title
Mean IOP change from baseline
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Visualization of OTX-TP punctum plug by subject
Description
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.
Time Frame
90 days
Other Pre-specified Outcome Measures:
Title
Best corrected visual acuity
Time Frame
90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Umhlanga Hospital Medical Centre
City
Durban
Country
South Africa
12. IPD Sharing Statement
Learn more about this trial
Multi-Arm Feasibility Study Evaluating OTX-TP Compared to Timolol in Treatment of Subjects With Open Angle Glaucoma
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