In this research study, we will assess the safety, tolerability, comfort, and feasibility of lowering intraocular pressure using a novel Contact Lens Drug Delivery System with latanoprost. Latanoprost is a well-studied medication and has been used to treat glaucoma for decades. Currently, latanoprost is FDA-approved to be administered to patients as eye drops, but using eye drops has challenges (having to remember to take the drop, getting the drop in the eye). This clinical trial is being done to determine the safety, tolerability, and effectiveness of using latanoprost to deliver latanoprost in a new way (through a drug-eluting contact lens). The study includes two phases. Phase A is intended to assess safety and tolerability and Phase B to assess safety and effectiveness.
In Phase A of this study, five subjects will wear the latanoprost-eluting contact lens (L-CL) for one week. Phase A is designed to assess for safety and tolerability. In Phase B of this research study, we will compare the L-CL to placebo. Patients will be randomized to one of 2 groups. Subjects in Group 1 will receive the contact lens with latanoprost in it (latanoprost contact lens, or "L-CL") and placebo eye drops. Subjects in Group 2 will receive a standard, commercial contact lens (or "C-CL) that contains no latanoprost but will be given latanoprost eye drops. The placebo contact lens (C-CL) is highly similar to the latanoprost-eluting contact lens but contains no latanoprost. The placebo eye drops look just like latanoprost eye drops but contain no latanoprost.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1
The latanoprost-contact lens will be worn in one eye for one week.
A commercial contact lens with no drug will be worn in one eye for one week.
Massachusetts Eye and Ear
Boston, Massachusetts, United States
Incidence of Treatment-Emergent Adverse Events as assessed by ocular infection, corneal epithelial defects, or cystoid macular edema - Phase A
Safety assessed by the occurrence of the following adverse events: ocular infection, corneal epithelial defects or signs of corneal toxicity that are not contact lens staining patterns, superficial punctate or vortex, cystoid macular edema
Time frame: 6 - 14 weeks
Incidence of Treatment-Emergent Adverse Events as assessed by ocular infection, corneal epithelial defects, or cystoid macular edema - Phase B
Safety assessed by the occurrence of the following adverse events: ocular infection, corneal epithelial defects or signs of corneal toxicity that are not contact lens staining patterns, superficial punctate or vortex, cystoid macular edema
Time frame: 6 weeks
Efficacy assessed by changes in intraocular pressure - Phase B
Effectiveness: % change in intraocular pressure (IOP) from baseline (following washout, i.e., on no medications) in each arm ; Difference in mean intraocular pressure comparing the L-CL arm to the topical latanoprost arm; % change in IOP in each arm compared to baseline IOP on topical latanoprost
Time frame: 6 weeks
Preliminary efficacy - Phase A: % change in IOP from baseline
Assess by comparing % change in IOP from baseline following washout (i.e., on no medications), % change in IOP from topical latanoprost compared to the L-CL
Time frame: 6 - 14 weeks
Tolerability and comfort: questionnaire
We will assess the tolerability and comfort of the L-CL by using the validated questionnaire Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8). The CLDEQ-8 has as a minimum value a score of 1 and as a maximum value a score of 37. A higher score means a worse outcome.
Time frame: 6- 14 weeks
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