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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.
OTX-DED is the drug name used in clinical trials for this investigational treatment. No alternative names have been reported for this asset. It is being studied specifically for dry eye disease and dry eye syndromes.