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Glaucoma Drug-Eluting contact lens trial halted after single patient

NCT ID NCT04500574

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

1 person

The number who actually took part.

Started

Apr 2024

Finished

Oct 2025

Lead sponsor

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

18 to 85 years

Sex

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

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

  • Massachusetts Eye and Ear

    Boston, Massachusetts, 02114, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.