Status:
TERMINATED
Latanoprost Eluting Contact Lens for Treating Glaucoma and Ocular Hypertension
Lead Sponsor:
Massachusetts Eye and Ear Infirmary
Collaborating Sponsors:
Harvard University
Conditions:
Glaucoma
Ocular Hypertension
Eligibility:
All Genders
18-85 years
Phase:
PHASE1
Brief Summary
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...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 3 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 10 2025
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT04500574
Start Date
April 3 2024
End Date
October 10 2025
Last Update
October 15 2025
Active Locations (1)
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1
Massachusetts Eye and Ear
Boston, Massachusetts, United States, 02114