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.
None
None
Single group
Dexamethasone
DrugThe investigators have developed a topically-applied corticosteroid-delivery system that has the potential to treat recurrent cystoid macular edema with fewer risks to patient, and more dose control. The system is comprised of a drug-polymer film that is completely encapsulated within the periphery of a hydrogel that is commonly used to make contact lenses.
Occurrence of Contact Lens Related Ocular Infection
Number of ocular infection incidents for the duration of the study
Occurrence of Corneal epithelial Defect
Number of corneal epithelial defects incidents for the duration of the study
Occurrence of ocular hypertension greater than 28
Number of ocular hypertension incidents for the duration of the study (ocular hypertension greater than 28)
OCT Macular Thickness Change
Changes in ocular coherence tomography (OCT) macular thickness over the duration of the study
Percentage of subject that achieve OCT Macular Thickness Decrease of 50 μm
Percentage of subjects that achieve a 50 μm decrease in OCT macular thickness from baseline to study completion
Changes is Visual Acuity
Change in vision (letter gain with and without pinhole vision) from baseline to the end of the study.
Percentages of subjects with 15 letter gain
Percentage of subjects that achieve a 15 letter gain from baseline to the end of the study
Changes in Modified Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8)
Change in subjects survey scores over time. Total score range between 1 - 28. Lower CLDEQ score means subject are experiencing high comfort. High CLDEQ score means higher discomfort.
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