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Also known as OTX-DP (Dexamethasone punctum plug)
OTX-DP · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Dexamethasone Punctum Plug | ACTIVE_COMPARATOR | Sustained and tapered release of dexamethasone from hydrogel punctum plug following insertion over 30 days |
| Placebo Vehicle Punctum Plug | PLACEBO_COMPARATOR | Placebo punctum plug insertion |
| Name | Type | Description |
|---|---|---|
| OTX-DP (Dexamethasone punctum plug) | DRUG | Sustained and tapered release of dexamethasone from hydrogel punctum plug |
| Placebo Vehicle Punctum Plug | DRUG | Hydrogel punctum plug without dexamethasone |
Inclusion Criteria: * Has provided written informed consent, approved by the appropriate institutional review board; and is able to comply with study requirements and visit schedule * Is greater than or equal to 21 years of age * Has a cataract and is expected to undergo clear corneal cataract surg...
OTX-DP is an investigational small molecule product developed by Ocular Therapeutix, Inc. for ocular inflammation and pain. It combines dexamethasone with a punctum plug, a device placed in the tear duct to deliver the drug. It has been studied in a Phase 2 clinical trial in patients undergoing cataract surgery.
OTX-DP is being developed for the treatment of ocular inflammation and pain, including inflammation and pain following cataract surgery. Its only recorded clinical trial enrolled patients with ocular inflammation and pain after cataract surgery. It is investigational and has not been approved for commercial use.
OTX-DP is developed by Ocular Therapeutix, Inc., which trades on the Nasdaq under the ticker OCUL. The company is the sponsor of the Phase 2 trial evaluating the product for ocular inflammation and pain after cataract surgery.
OTX-DP is in Phase 2 development. One Phase 2 trial has been completed, and no trials are currently active. The completed study was a randomized, double-blind, placebo-controlled trial of 60 patients with ocular inflammation and pain after cataract surgery in the United States.
OTX-DP has been studied in one completed Phase 2 trial, NCT01666210, titled a Phase II Study Evaluating Safety/Efficacy of OTX-DP for Treatment of Ocular Inflammation and Pain After Cataract Surgery. It enrolled 60 patients aged 21 and older in the United States and was randomized, double-blind, and placebo-controlled.
Yes. OTX-DP is also known as dexamethasone punctum plug, reflecting its combination of the corticosteroid dexamethasone with a punctum plug delivery system. Searches for either name refer to the same investigational Ocular Therapeutix product for ocular inflammation and pain.