Evaluation of a new antifungal drug - Voriconazole, for the treatment of Fungal ulcer

A multicentric masked randomized clinical study to assess the efficacy of 1% Voriconazole eye drops compared to 5% Natamycin eye drops in the treatment of mycotic keratitis

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/003041

Enrollment

120

Registered

2010-12-27

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Treatment of Fungal Keratitis

Interventions

Intervention1: 1% Voriconazole eye drop: Initial dose- One hourly, modified based on clinical response, continued until resolved Control Intervention1: 5% Natamycin eye drop: Initial dose- One hourly,

Eligibility

Inclusion criteria

Inclusion criteria: 1) Age equal to or more than 18 years. 2) Male or female 3) Duration of complaints not more than past 14 days of presentation to the study center. 4) Presence of a corneal epithelial defect with stromal infiltrate or exudate, clinically suggestive of fungal ulcer with or without hypopyon. The diameter of the ulcer will be between 2 mm and 6 mm, as long as there is no scleral involvement. 5) Corneal scraping positive for fungal filaments in direct smear examination by any one or more of the methods used. 6) None or Inadequate prior treatment with antifungal eye drop (less than 6 times per day).

Exclusion criteria

Exclusion criteria: 1) The corneal scrapings are negative for fungal filaments. 2)The patient has a history of allergy to voriconazole or natamycin. 3)The cornea or sclera has been perforated or perforation is impending. 4)The unaffected eye is legally blind. 5)Dacrocystitis is present. 6)Neurotrophic keratitis, exposure keratitis or keratitis sicca is present. 7)Prescribed topical or systemic steroids or other immunosupressants are being used, unless discontinued before randomization. 8)The patient is known to be HIV positive or diabetic. 9) The infiltrate extends into the posterior one-third of the stroma. 10) The initial culture shows significant growth of bacteria ( >10 colonies). 11)Any topical antifungal agent has been used in adequate dosage (4 hourly) within the past one week. 12)Both eyes are infected.

Design outcomes

Primary

Measure	Time frame
Healed corneal ulcerTimepoint: 1 week, 2 weeks, 3 weeks	—

Secondary

Measure	Time frame
Resolving corneal ulcer, Worsened corneal ulcer, Visual ourcomeTimepoint: 3 weeks	—

Countries

India

Contacts

Public ContactSavitri Sharma

L V Prasad Eye Institute

savitri@lvpei.org0674-3987129

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026