Randomized, Prospective, Vehicle-Controlled, Phase I/II Clinical Trial to Evaluate the Safety and Feasibility of a Therapeutic Contact Lens Drug Delivery System (TCL-DDS) in Patients With Recurrent Cystoid Macular Edema

This is a single center study to assess safety and feasibility of delivering dexamethasone through the TCL-DDS delivery system as a treatment for recurrent cystoid macular edema. The study has two phases. The study begins with phase A, which is an open label study in that will enroll up to 6 subject. The goal of this phase is to have 3 subjects complete the study. The enrollment number is 6 in order to accommodate for withdraws and/or terminations (for reasons other than adverse event to the study intervention and include loss of the lens before 7 days). Subjects will wear the TCL-DDS in one eye for one week during which time they will be closely followed with examinations at 1 hour, 6 hours, 24 hours, 3 days, and 7 days. After the TCL-DDS is removed after 7 days of wear, the subjects will be followed with weekly examinations for 3 additional weeks for evaluation of safety. If the TCL-DDS is found to be safe after review of the clinical data by monitoring board, phase B will be initiated that will study the safety and effectiveness of delivering dexamethasone through the TCL-DDS. This clinical trials submission only relates to phase A of the study design.

During Phase A, a commercial contact lens (Kontur Kontact Lens, Hercules, CA) that has the same dimensions and thickness (16.0 mm diameter and 8.6 mm base curve) as the TCL-DDS will be placed on the study eye and worn for a 1 hour run-in period. This run in period will be used to help identify subjects who can tolerate a contact lens with the same dimensions and parameters as the TCL-DDS. Those subjects that cannot wear the commercial contact lens due to problems with fitting of the lens, comfort, or other reasons will be excluded from the study. We will evaluate comfort and examine the eye for signs of ocular irritation and inflammation, which may include slit lamp findings of conjunctiva redness, the pattern of any conjunctiva redness, anterior chamber reaction, discharge, and pupillary dilation.

If the contact lens is worn comfortably without signs of ocular irritation, then the commercial lens will be removed and replaced with a TCL-DDS. The eye will be examined at 1 hour, 6 hours, 24 hours, 3 days, and 7 days. We will evaluate comfort and examine the eyes for signs of ocular irritation by slit lamp examination. In addition, we will check intraocular pressure on day 7.

The eye will be assessed again at Day 14, 21, and 28. During the examinations, the study eyes will have the intraocular pressure measured and will be evaluated by slit lamp examination for associated adverse events to determine the safety of the TCL-DDS. Phone call assessments in place of scheduled clinic visits will be completed on Day 2 and Day 4 for safety checks. Information on adverse events will be collected at each study visit, including phone visits, from screening to Day 28. The subject will then attend a final follow up evaluation visit at Day 28 that will conclude the subject's participation in the study.

After the first 3 subject s (up to 6 subjects enrolled) in Phase A complete their day 28 visit, and it is determined that the TCL-DDS is safe and well tolerated, 15 additional subjects will be enrolled into Phase B of the study.