Glaucoma Drug-Eluting contact lens trial halted after single patient
NCT ID NCT04500574
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a special contact lens that slowly releases the glaucoma drug latanoprost, aiming to replace daily eye drops. Only one person enrolled before the study was stopped early. The goal was to check safety and whether the lens could lower eye pressure, but no conclusions can be drawn from such a small trial.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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1 person
The number who actually took part.
- Started
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Apr 2024
- Finished
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Oct 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 85 years
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Massachusetts Eye and Ear
Boston, Massachusetts, 02114, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- The 20-Minute squeeze: how eye injections push pressure up
- One operation for cataract and glaucoma? eye surgeons test a Two-in-One approach
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- Eye drops may shield the cornea after cataract surgery