A clinical Trial in patients with Herpes Keratitis. Clinical trial is to study efficacy, safety and tolerability of Ganciclovir ophthalmic gel in comparison to Acyclovir ophthalmic ointment (reference product).
- Conditions
- Health Condition 1: null- Herpes KeratitisHealth Condition 2: B108- Other human herpesvirus infection
- Registration Number
- CTRI/2010/091/000198
- Lead Sponsor
- Ajanta Pharma Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
1. Clinical diagnosis of Herpes Keratitis confirmed by Laboratory evaluation (microscopic examination confirmed by slit lamp examination of eye).
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. Those who had immunosuppressive, antiviral or steroid therapy in the preceding 14 days.
4. Those who had stromal corneal involvement or keratouveitis.
5. Viral keratitis with big scars
6. Any keratitis associated with other keratitis e.g. Bacterial and fungal keratitis
7. Any patient having OSD with viral keratitis
8. Any patient having dry eyes with viral keratitis
9. Significant history or presence of gastrointestinal, liver or kidney disease or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of common medications
10. Pregnant or nursing females
11. Participation in a clinical trial with an investigation drug within 30 days proceeding day one of this study.
12. 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 examination of eyeTimepoint: Day 0, Day 3, Day 7, Day 10 and Day 14.
- Secondary Outcome Measures
Name Time Method Inflammation of cornea, Irritation and pain in the eye, Redness of eye, Blurred vision, Tearing, Sensitivity to light, Watery discharge from eyeTimepoint: Day 0, Day 3, Day 7, Day 10 and Day 14