Therapeutic Contact Lens Drug Delivery System (TCL-DDS) in Patients With Recurrent Cystoid Macular Edema
Status:
Recruiting
Trial end date:
2021-12-31
Target enrollment:
Participant gender:
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.