Condition: Cystoid Macular Edema · Sponsor: Massachusetts Eye and Ear Infirmary
The main aim of the pilot study is to determine preliminary estimates of the safety, tolerability, and comfort of a dexamethasone-eluting therapeutic contact lens drug delivery system (TCL-DDS) for the treatment of recurrent cystoid macular edema. Secondarily, feasibility of the TCL-DDS system will be investigated. 1. Safety: To establish that a topical dexamethasone delivery system has an acceptable safety profile by determining the incidence and severity of ocular adverse events, as identified by eye examination through day 28 following treatment initiation. 2. Comfort and tolerability: to establish the subject tolerability and comfort of the TCL-DDS. 3. Feasibility: To establish- that a topical dexamethasone delivery system is a feasible treatment for recurrent cystoid macular edema.
This description comes directly from the study's public registry record.
Demetrios Vavvas, M.D., Ph.D. · 617-573-4174 · demetrios_vavvas@meei.harvard.edu
Odeta Dyrmishi · 617-573-6823 · Odeta_dyrmishi@meei.harvard.edu
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| MEEI | Boston, Massachusetts, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT04225611