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).

A Comparative, Randomized, Single blind, Multicentric, Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Ganciclovir ophthalmic gel 0.15 % (Mfg by Ajanta Pharma) Vs Acyclovir ophthalmic ointment 3 % in patients with Herpes Keratitis

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/000198

Enrollment

200

Registered

2010-03-04

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 Keratitis Health Condition 2: B108- Other human herpesvirus infection

Interventions

Intervention1: Ganciclovir ophthalmic gel 0.15 %: One drop in the affected eye 5 times per day (approximately every 3 hours while awake) until the corneal ulcer heals, and then 1 drop 3 times per day

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
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	—

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