Light-Activated dye could save sight from severe eye infections
NCT ID NCT06271772
First seen Jun 27, 2026 · Last updated Aug 18, 2026 · Updated 2 times
Summary
This study tests whether a light-activated dye called rose Bengal, combined with antibiotics and steroids, can improve vision in people with severe bacterial eye infections. About 60 adults with corneal ulcers and vision loss will receive either the dye treatment or a sham procedure. The goal is to see if the dye helps reduce scarring and leads to 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 (a dye) activated by green light, plus antibiotic and steroid eye drops
- What this could lead to
- If it works, this could offer a new way to treat severe bacterial eye infections, potentially improving vision and reducing scarring.
- What could go wrong
- This is a small, early feasibility study with only 60 participants. The treatment adds complexity and may not provide significant benefit over standard care. Risks include eye irritation or worsening infection.
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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60 people
The number who actually took part.
- Started
-
Jul 2024
- Expected to finish
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Feb 2027
An estimate. End dates often move.
- 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 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Corneal ulcer that is smear positive and/or culture positive (within 24 hours) for typical bacteria (i.e. non-Nocardia or Myobacteria) * 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 * Presence of desmetocele at recruitment * Non-infectious or autoimmune keratitis * History of corneal transplantation * History of intraocular surgery within the last three months\* * Pinhole visual acuity worse than 20/200 in the unaffected eye * Participants who are decisionally and/or cognitively impaired
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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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Aravind Eye Care System
Madurai, Tamil Nadu, India
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Federal University of São Paulo
São Paulo, Brazil
More trials for these conditions
Other studies related to the condition(s) this trial covers.