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Fungal Ulcer Treatment Augmented With Natamycin and Cyclosporine A

RecruitingPhase 3

Sponsor: University of California, San Francisco

Conditions: Fungal Keratitis, Corneal Ulcer

Interventions: Cyclosporine A, Placebo Comparator: Placebo

Countries: United States, India

The goal of this clinical trial is to learn if adjunctive topical Cyclosporine A eye drops combined with standard of care topical Natamycin treatment improves vision outcomes in patients with fungal keratitis.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (2)

San Francisco, California, United States
Pondicherry, Tamil Nadu, India