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Efficacy of Natamycin Monotherapy vs. Natamycin with Posaconazole in Mild to Moderate Fungal Keratitis

Comparative Efficacy of Natamycin Monotherapy vs. Natamycin with Posaconazole in Mild to Moderate Fungal Keratitis: A Randomized Controlled Trial - NIL

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/04/085722
Enrollment
120
Registered
2025-04-28
Start date
Unknown
Completion date
Unknown
Last updated
2025-05-26

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

Conditions

Health Condition 1: H160- Corneal ulcer

Interventions

Intervention1: Antifungal Therapy: Natamycin monotherapy versus Natamycin with Posaconazole. Follow ups on 3 days, 1 week, 2 weeks, 4 weeks, 6 weeks, 2 months, and 3 months. Control Intervention1: Ant

Sponsors

L V Prasad Eye Institute
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Microbiologically confirmed fungal keratitis (smear and/or culture positive). 2.No prior antifungal use exceeding six times per day for more than 10 days. 3.Corneal infiltrate size 2 6 mm, with stromal involvement not exceeding two-thirds of corneal thickness. 4.Vision in the other eye better than 20/200. 5.Willingness to participate in the study. 6.Non-pregnant individuals. 7.Systemically stable patients. 8.Willingness for admission or regular follow-up.

Exclusion criteria

Exclusion criteria: 1.Mixed infection 2.Participant not willing to participate 3.Having Advanced form of infection 4.Limbal involvement 5.Scleral involvement 6.Posterior chamber involvement

Design outcomes

Primary

MeasureTime frame
1.Number of cases achieving medical cure. 2.Incidence of corneal perforations. 3.Number of patients requiring urgent TPK. Timepoint: 3 days, 1 week, 2 weeks, 4 weeks, 6 weeks, 2 months, and 3 months.

Secondary

MeasureTime frame
Number of patients requiring urgent TPK.Timepoint: 1 week, 2 weeks, 1 month, 3 months

Countries

India

Contacts

Public ContactDrBhupesh Bagga

L V Prasad Eye Institute

bhupesh@lvpei.org04068102615

Outcome results

None listed

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