Health TrialsbyHealthPanel

Fungal Ulcer Treatment Augmented With Natamycin and Cyclosporine A

ConditionsFungal KeratitisCorneal Ulcer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, San Francisco

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Factorial

Treatments tested in this trial

  • Cyclosporine A

    Drug

    Participants with smear or culture proven fungal keratitis are treated for a minimum of 48 hours with topical natamycin and then randomized in a 1:1:1 ratio to receive either topical Cyclosporine A (CsA) 0.1%, 2% or placebo for 4 weeks. Natamycin is continued until the ulcer has healed.

  • Placebo Comparator: Placebo

    Other intervention

    Participants with smear or culture proven fungal keratitis are treated for a minimum of 48 hours with topical natamycin and then randomized in a 1:1:1 ratio to receive either topical Cyclosporine A (CsA) 0.1%, 2% or placebo for 4 weeks. Natamycin is continued until the ulcer has healed.

Treatment groups

150 Participants
are divided into 3 treatment groups
Group A: Cyclosporine A (CsA) 0.1%Experimental treatment 1 intervention
Group B: Cyclosporine A (CsA) 2%Experimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Best Spectacle Corrected Visual Acuity (BSCVA)

Time frame
12 weeks

Secondary outcomes

1

Corneal Scar Size

Time frame
12 weeks
2

Corneal Perforation Rate

Time frame
12 weeks
3

Corneal Ulcer Re-epithelialization

Time frame
12 weeks
4

Microbiologic Cure Rate

Time frame
12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, San Francisco

Lead sponsor

Aravind Eye Hospitals, India

Collaborator

Aravind Eye Care System

Collaborator

Source ClinicalTrials.gov
Apply now