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Green light and pink dye take on tough eye infections

NCT ID NCT05110001

Disease control Sponsor: University of California, San Francisco Source: ClinicalTrials.gov ↗

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 This study
The trial has finished. Results may not be published yet.
Stopped early
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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Sep 04, 2026 · Updated 3 times

Summary

This study tested whether adding a light-activated dye (rose bengal) to standard antibiotic or antifungal eye drops could improve vision in people with severe corneal infections. About 330 adults in India and Brazil with fungal or amoeba infections received either standard drops alone or drops plus the dye-and-light treatment. The main goal was to see which group had better eyesight after six months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Rose Bengal dye activated by green light (photodynamic therapy)
What this could lead to
If successful, this could offer a new way to treat stubborn corneal infections and reduce vision loss without needing stronger drugs.
What could go wrong
This is an early-phase trial with 330 participants; the added light therapy may not improve outcomes over standard drugs alone, and risks include eye irritation or scarring.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

330 people

The number who actually took part.

Started

Aug 2022

Finished

Jun 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 years and older

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: * Presence of smear or culture positive fungal or acanthamoeba ulcer; smear or culture negative ulcer; or any atypical bacteria (such as Nocardia) * Moderate to severe vision loss, defined as Snellen visual acuity of 20/40 (6/12) or worse * Corneal thickness ≥350 µm, as measured on AS-OCT * Age over 18 years * Basic understanding of the study as determined by the physician * Commitment to return for follow up visits Exclusion Criteria: * Evidence of concomitant infection on exam, gram stain, or confocal microscopy (i.e. herpes, both bacteria and acanthamoeba on gram stain) * Impending or frank perforation at recruitment * Involvement of sclera at presentation * Non-infectious or autoimmune keratitis * History of corneal transplantation * History of intraocular surgery within last three months * Pinhole visual acuity worse than 20/200 in the unaffected eye * Participants who are decisionally and/or cognitively impaired * Presence of demestocele at recruitment

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Conditions

The condition(s) this trial relates to.

Acanthamoeba keratitis corneal ulcer fungal keratitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acanthamoeba keratitis Fungal keratitis

Contacts and locations

Locations

  • Aravind Eye Care System

    Madurai, Tamil Nadu, India

  • Federal University of São Paulo

    São Paulo, Brazil

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