Clinical Trial

Therapeutic Contact Lens Drug Delivery System (TCL-DDS) in Patients With Recurrent Cystoid Macular Edema

Study acronym: ContactLens
Recruiting Phase 1/2
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Summary
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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2020-01-08; most recent amendment 2025-11-24.
Status change: Not Yet Recruiting → Recruiting 2021-03-24
Trial Details
NCT Number NCT04225611
Lead Sponsor Massachusetts Eye and Ear Infirmary
Conditions Cystoid Macular Edema
Enrollment 6 participants
Start Date 2021-03-15
Primary Completion 2027-12-31 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-11-26