Combination Treatment of 5% Natamycin and 1% Voriconazole in Fungal Keratitis

• Status: Unknown status
• Trial end date: 2018-09-30
• Target enrollment: 0
• Participant gender: All

Summary

OBJECTIVE To evaluate the efficacy and safety of the concurrent treatment of 5% Natamycin and 1% Voriconazole in patients affected by fungal keratitis METHODS AND MATERIALS STUDY POPULATION Patients with smear and or culture proven fungal keratitis presenting to our Instituts, were eligible for enrollment.

STUDY DESIGN Prospective double masked randomized clinical trial.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: L.V. Prasad Eye Institute
• Treatments: Natamycin; Ophthalmic Solutions; Tetrahydrozoline; Voriconazole

Criteria

Inclusion Criteria:

• Subjects > 18 yrs of age Willing to give appropriate informed consent Presence of corneal ulcer measuring > 2mm in vertical and horizontal dimensions at presentation (epithelial defect and signs of stromal inflammation) Microbiologic evidence of fungus on smear and or culture media Willing to return for all the follow up visits

Exclusion Criteria:

• Patients not willing to give consent Patients unable to cooperate for the procedure Patient with impending, or actual perforation or bilateral corneal ulcer or scleral involvement History of previous ocular surgery Evidence of bacterial, parasitic or viral infection or co-infection Previous corneal scar Known allergy to the study medication (drug or preservative) Pregnant or nursing females Immunocompromised patients