Glaucoma
Conditions
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.
Interventions
DRUGOTX-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.
DRUGOTX-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.
DRUGTimolol 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.
Sponsors
Ocular Therapeutix, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean IOP change from baseline | 90 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Other
| Measure | Time frame |
|---|---|
| Best corrected visual acuity | 90 days |
Countries
South Africa
Outcome results
None listed