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To evaluate the safety and IOP lowering efficacy of OTX-TP, a sustained release travoprost drug product, placed in the canaliculus of the eyelid compared to Timolol Maleate Ophthalmic Solution, 0.5% in the treatment of subjects with open angle glaucoma or ocular hypertension. The study is designed to assess clinically meaningful response to treatment and is not powered to measure any efficacy endpoints with statistical significance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OTX-TP treatment | Active Comparator | OTX-TP (sustained release travoprost, 0.36 mg) to be used in this trial with placebo drops administered separately |
|
| Timolol control | Active Comparator | Timolol Maleate Ophthalmic Solution, 0.5% dosed twice daily (BID) in the presence of a placebo vehicle punctum plug (PV). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OTX-TP | Drug | OTX-TP and placebo drops |
| |
| Timolol |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in the mean change from baseline average diurnal IOP between treatment groups at the Day 60 Visit | Days 57 to 63 | |
| Difference in the mean change from baseline average diurnal IOP between treatment groups at the Day 90 Visit | Days 87 to 93 | |
| Difference in the mean change from baseline IOP between treatment groups to each individual time point at the Day 60 and 90 Visits | Days 57 to 63 and Days 87 to 93 | |
| Difference in mean IOP between treatment groups for the average diurnal IOP and to each individual time point at the Day 60 and 90 Visits | Days 57 to 63 and Days 87 to 93 | |
| Difference in the mean percent change from baseline IOP between treatment groups for the average diurnal IOP and to each individual time point at the Day 60 and 90 Visits | Days 57 to 63 and 87 to 93 |
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Inclusion Criteria:
Subject must have a documented diagnosis of ocular hypertension, open angle glaucoma (with or without pseudoexfoliation or pigment dispersion component).
Subject has a mean baseline IOP following washout in at least 1 eye (the same eye) of
≥ 24mmHg at Hour 0 (T0) at Baseline Visit 1 and Baseline Visit 2 (Day 1)
Subject has a mean baseline IOP following washout in at least 1 eye (the same eye) of:
≥ 22mmHg at (T0 + 4h) and (T0 + 8h) at Baseline Visit 1 (note: the same eye must meet the IOP eligibility criteria at all 4 baseline assessments)
Washout IOP must be ≤ 34mmHg in each eye at all time points at the Baseline Visit 1 and Baseline Visit 2 (Day 1)
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vold Vision | Fayetteville | Arkansas | 72704 | United States |
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| Drug |
Timolol drops and placebo punctum plug |
|
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D013999 | Timolol |
| ID | Term |
|---|---|
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D013830 | Thiadiazoles |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009025 | Morpholines |
| D010078 | Oxazines |
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