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).
- Conditions
- Health Condition 1: null- Herpes infection of eyeHealth Condition 2: B108- Other human herpesvirus infection
- Registration Number
- CTRI/2010/091/000563
- Lead Sponsor
- Ajanta Pharma Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
1. Clinical diagnosis of Herpes infection of eye confirmed by laboratory evaluation
2. Written informed consent by patient.
3. Patient willing to follow up.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Slit lamp examinationTimepoint: Day 0, Day 3, Day 7, Day 10 and Day 14.
- Secondary Outcome Measures
Name Time Method 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.