Latanoprost Eluting Contact Lens for Treating Glaucoma and Ocular Hypertension

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Latanoprost Eluting Contact Lens for Treating Glaucoma and Ocular Hypertension

Conditions
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Glaucoma, Ocular Hypertension

Intervention / Treatment
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* Drug: Latanoprost eluting contact lens
* Drug: Topical Latanoprost


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 - 85 years of age willing and able to give informed consent and in the investigator's judgment able to follow the study protocol Ocular hypertension, primary open-angle glaucoma, pigmentary or pseudoexfoliation glaucoma, with mild to moderate glaucoma defined as Mean Deviation on Humphrey Visual Field testing no worse than -10 dB Patients on latanoprost in the study eye with an adequate IOP control with latanoprost alone Exclusion Criteria: Systemic Use of oral carbonic anhydrase inhibitors Unstable dose of oral medication during the last 30 days that in the opinion of the Investigator may influence the IOP Unstable dose of oral steroid at the time of enrollment Use of immunosuppressants, immunomodulators, antimetabolites and/or alkylating agents within six months before screening or anticipated use at any time during the study Known allergy or hypersensitivity to the study medication or its components Female patients who are pregnant, nursing, or planning a pregnancy, or who are of childbearing potential and not using a reliable means of contraception Participation in an investigational drug or device study within the 30 days before screening Patient has a condition or is in a situation which, in the Investigator's opinion, may put the patient at significant risk, may confound the study results, or may interfere significantly with the patient's participation in the study Any condition (including the inability to read visual acuity charts or language barrier) which precludes a patient's ability to comply with study requirements including completion of the study Study Eye History of complex cataract surgery with vitreous loss History of cystoid macular edema or uveitis Corneal decompensation or edema Corneal thickness <500 or > 600 μm in the study eye by pachymetry Prior treatment-related adverse event or allergy to latanoprost Evidence of macular edema/intraretinal fluid on screening macula optical coherence tomography (OCT) Any ocular condition in the study eye that in the opinion of the investigator would prevent the eye from wearing a contact lens (e.g., ectropion, lid abnormality, or symblepharon) Use of beta-blocker, alpha agonist, rho kinase inhibitor, or carbonic anhydrase inhibitor drops within 1 month prior to screening; the use of latanoprost must be stable for at least 4 weeks prior to screening Use of latanoprost for < 4 weeks prior to screening Use of topical steroids Active optic disc or retinal neovascularization in the study eye at screening Presence of rubeosis iridis in the study eye at screening History of herpetic infection in the study eye or adnexa Media opacity in the study eye at screening that precludes clinical and photographic evaluation (including but not limited to preretinal or vitreous hemorrhage, lens opacity) Intraocular surgery, including cataract surgery, and/or laser of any type in the study eye within 30 days prior to screening History of kerato-refractive surgery Any prior filtering surgery, including trabeculectomy, glaucoma drainage device, or Xen implant Inability to comfortably wear a commercial contact lens (C-CL) that has the same dimensions as the L-CL during the week-long run-in period Both Eyes: any active ocular infection (i.e., bacterial, viral, parasitic, or fungal) in either eye at screening Non-study Eye: Pinhole score < 19 letters (at least 20/400 Snellen equivalent) in the non-study eye at the screening visit

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a single-center study to assess the safety and feasibility of delivering latanoprost using the latanoprost contact lens (L-CL) delivery system as a treatment for glaucoma or ocular hypertension. The study has two phases. Phase A is an open-label study with 5 participants; these individuals will wear the L-CL in one eye for one week during which time they will be closely followed with examinations for evaluation of safety. If the L-CL is found to be safe after review of the clinical data by a data and safety monitoring board, phase B will be initiated to assess the safety and effectiveness of delivering latanoprost through the L-CL. This is a double-masked double-dummy study. The L-CL arm will have the drug-eluting latanoprost contact lens (L-CL) and a sham drop, and the latanoprost arm will have a C-CL (no drug) with a nightly 0.005% latanoprost drop.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Latanoprost contact lens<br>The L-CL arm will have the drug-eluting latanoprost contact lens (L-CL) and a sham drop. | Drug: Latanoprost eluting contact lens<br>* The latanoprost-contact lens will be worn in one eye for one week.<br>|
| Placebo Comparator: Topical Latanoprost<br>The placebo arm will have a commercial contact lens with no drug with a nightly 0.005% latanoprost drop. | Drug: Topical Latanoprost<br>* A commercial contact lens with no drug will be worn in one eye for one week.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 6- 14 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Latanoprost, Glaucoma, Ocular Hypertension, Drug eluting contact lens