A clinical Trial in patients with Herpes infection of eye. Clinical trial is to study efficacy, safety and tolerability of Trifluridine Eye Drops in comparison to Idoxuridine eye drops (reference product).

A Comparative, Randomized, Single blind, Multicentric, Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Trifluridine Eye Drops 1% Vs Idoxuridine eye drops 0.1 % in patients with Herpes infection of eye.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/000563

Enrollment

100

Registered

2010-06-04

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- Herpes infection of eye Health Condition 2: B108- Other human herpesvirus infection

Interventions

Intervention1: Trifluridine Eye Drops 1%: one drop every 2 hours while awake for a maximum daily dosage of nine drops for a period of 14 days Control Intervention1: Idoxuridine eye drops 0.1 %: One dr

Eligibility

Inclusion criteria

Inclusion criteria: 1. Clinical diagnosis of Herpes infection of eye confirmed by laboratory evaluation 2. Written informed consent by patient. 3. Patient willing to follow up.

Exclusion criteria

Exclusion criteria: 1. Patients < 18 & > 60 years. 2. History of hypersensitivity to the study drug or similar class of drug. 3. Viral keratitis with big scars 4. Any keratitis associated with other keratitis e.g. Bacterial and fungal keratitis 5. Any patient having OSD with viral keratitis 6. Any patient having dry eyes with viral keratitis 7. Pregnant or nursing females 8. Participation in a clinical trial with an investigation drug within 30 days proceeding day one of this study. 9. Any condition that, in the opinion of the investigator, does not justify the patient?s inclusion in the study.

Design outcomes

Primary

Measure	Time frame
Slit lamp examinationTimepoint: Day 0, Day 3, Day 7, Day 10 and Day 14.	—

Secondary

Measure	Time frame
Blurred visionTimepoint: Day 0, Day 3, Day 7, Day 10 and Day 14.;Inflammation of corneaTimepoint: Day 0, Day 3, Day 7, Day 10 and Day 14;Irritation and pain in the eyeTimepoint: Day 0, Day 3, Day 7, Day 10 and Day 14.;Redness, swelling around eyeTimepoint: Day 0, Day 3, Day 7, Day 10 and Day 14.;Sensitivity to lightTimepoint: Day 0, Day 3, Day 7, Day 10 and Day 14.;TearingTimepoint: Day 0, Day 3, Day 7, Day 10 and Day 14.;Watery discharge from eyeTimepoint: Day 0, Day 3, Day 7, Day 10 and Day 14.	—

Measure

Time frame

Blurred visionTimepoint: Day 0, Day 3, Day 7, Day 10 and Day 14.;Inflammation of corneaTimepoint: Day 0, Day 3, Day 7, Day 10 and Day 14;Irritation and pain in the eyeTimepoint: Day 0, Day 3, Day 7, Day 10 and Day 14.;Redness, swelling around eyeTimepoint: Day 0, Day 3, Day 7, Day 10 and Day 14.;Sensitivity to lightTimepoint: Day 0, Day 3, Day 7, Day 10 and Day 14.;TearingTimepoint: Day 0, Day 3, Day 7, Day 10 and Day 14.;Watery discharge from eyeTimepoint: Day 0, Day 3, Day 7, Day 10 and Day 14.

—

Countries

India

Contacts

Public ContactDr Shailesh Singh

Ajanta Pharma Ltd, Advent

shaileshs@ajantapharma.com022-66062112

Outcome results

None listed

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