Latanoprost Eluting Contact Lens for Treating Glaucoma and Ocular Hypertension

Eligibility 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
• * 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
• * 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