Natamycin plus cyclosporine eye drops for fungal corneal ulcers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, masked trial enrolls adults with smear- or culture-confirmed fungal keratitis who start standard topical natamycin for at least 48 hours. Participants are randomized 1:1:1 to receive topical cyclosporine A 0.1%, cyclosporine A 2%, or placebo for four weeks while continuing natamycin until the ulcer resolves. The primary outcome is best corrected visual acuity at three months, and investigators will analyze which ulcer features predict the most benefit. The trial is conducted at UCSF in partnership with Aravind Eye Hospital in India to enroll patients where fungal ulcers are common.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Inclusion is based on presenting acuity, not ulcer size.
* Inclusion of 20/40 = 6/12 = 0.3 Log MAR and 20/400 = 3/60 = +1.3 Log MAR.
* Smear or culture positive for fungal keratitis, any length.
* Age 18 years.
* Willing to participate in study.

Exclusion Criteria:

* Co-infection with bacterial or viral keratitis.
* Corneal perforation.
* Requiring therapeutic keratoplasty for fungal keratitis.
* Unwilling or unable to follow up (e.g., living too far from hospital).
* Presenting acuity better than 20/40 = 6/12 = 0.3 Log MAR or worse than 20/400 = 3/60 = +1.3 Log MAR.
* Subjects taking cyclosporine at any concentration on presentation.
* Acuity worse than 20/200 = 6/60 = +1.0 Log MAR in unaffected eye.
* Pregnant women.
* Penetrating Keratoplasty.
* Presents with a 0-7 day history of topical steroid.

Where it's running

• Aravind Eye Institute
  Pondicherry, Tamil Nadu, India Recruiting
• University of California, San Farncisco
  San Francisco, California, United States Not yet recruiting

Study contacts

• Principal investigator: Gerami D Seitzman, MD — UCSF Proctor Foundation
• Study coordinator: Gerami D Seitzman, MD
• Email: gerami.seitzman@ucsf.edu
• Phone: 4154761442

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.