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

Study acronym: ContactLens
StatusRecruiting
PhasePhase 1/2
Started
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Record History

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  1. Primary completion date: Dec 31, 2023 to Dec 31, 2027
    • Study completion date: Dec 31, 2024 to Dec 31, 2027
    v4
  2. Primary completion date: Dec 31, 2021 to Dec 31, 2023
    • Study completion date: Dec 31, 2021 to Dec 31, 2024
    • Eligibility criteria expanded, about 3 words
    v3
  3. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Primary completion date: Dec 2020 to Dec 31, 2021
    • Start date changed from estimate of Feb 2020 to Mar 15, 2021
    • Study sites: 0 to 1
    • Study completion date: Dec 2021 to Dec 31, 2021
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04225611
Lead Sponsor Massachusetts Eye and Ear Infirmary
Conditions
(from sponsor)		 Cystoid Macular Edema
Related terms Macular Edema
Enrollment 6 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov