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OTX-DED · 2 trials · 3 indications
Visual Analogue Scale (0 mm - no discomfort to 100mm - maximal (the most) discomfort)
The primary efficacy endpoint is photographic assessment of bulbar conjunctival hyperemia \[evaluated by the central reading center (CRC)\] in the study eye, change in score from baseline (CFB) at Visit 4 (Day 15). Scoring is from 0 (None) to 4 (Severe) on the CCLRU Grading Scale for Bulbar Conjunctival Hyperemia.
| Arm | Type | Description |
|---|---|---|
| OTX-DED 0.3mg | EXPERIMENTAL | - |
| Controlled Insertion utilizing Collagen Punctal Plug | EXPERIMENTAL | - |
| Collagen Punctal Plug (Full Insertion) | PLACEBO_COMPARATOR | - |
| OTX-DED 0.2mg | EXPERIMENTAL | Approximately 50 subjects |
| Hydrogel Vehicle (HV) | PLACEBO_COMPARATOR | Approximately 50 subjects |
| Name | Type | Description |
|---|---|---|
| OTX-DED | DRUG | 0.3mg dexamethasone ophthalmic insert |
| Controlled Insertion | DRUG | Collagen Punctal Plug 0.2mm (Controlled Insertion) |
| Collagen Punctal Plug | DRUG | Collagen Punctal Plug 0.2mm (Full Insertion) |
Inclusion Criteria: * VAS eye dryness severity score ≥ 35 and ≤ 90 at screening. * Investigator assessment of bulbar conjunctival hyperemia grade ≥ 2 (CCLRU; 0 - 4 scale). * Unanesthetized Schirmer of \> 0 and ≤ 10 mm. * Must not have used Artificial Tears during the Screening period. * IOP in both...
OTX-DED is an investigational small molecule being developed for the short-term treatment of signs and symptoms of dry eye disease. It is in Phase 2 clinical development for dry eye and dry eye syndromes, a condition in the ophthalmology therapeutic area.
OTX-DED is being developed by Ocular Therapeutix, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker OCUL. The company is conducting clinical trials of OTX-DED in the United States for the treatment of dry eye disease.
OTX-DED is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. Two Phase 2 clinical trials of OTX-DED have been completed, both evaluating the drug for the short-term treatment of dry eye disease.
OTX-DED has been studied in two completed Phase 2 clinical trials. The first, NCT04747977, enrolled 172 participants to assess efficacy and safety for short-term treatment of signs and symptoms of dry eye disease. The second, NCT05814757, enrolled 100 participants to evaluate short-term treatment of dry eye disease symptoms.