A clinical Trial in patients having allergic conjunctivitis. Clinical trial is to study efficacy, safety and tolerability of Tranilast Eye Drops 0.5% w/v in comparison to Ketorolac Tromethamine Eye Drops 0.5% w/v (reference product).

A comparative, single blind, parallel group, non-crossover, multi-centric clinical trial of Tranilast Eye Drops 0.5% w/v Vs Ketorolac Tromethamine Eye Drops 0.5% w/v, in patients having allergic conjunctivitis.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/000801

Enrollment

200

Registered

2009-10-08

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- Allergic conjunctivitis Health Condition 2: H108- Other conjunctivitis

Interventions

Intervention1: Tranilast Eye Drops 0.5% w/v: 1 drop four times a day for 7 days Control Intervention1: Ketorolac Tromethamine Eye Drops 0.5% w/v: 1 drop four times a day for 7 days

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age > 18 years 2. Availability of subjects for the entire study period and willingness to adhere to protocol requirements as evidenced by written informed consent. 3. Patient with signs and symptoms of allergic conjunctivitis diagnosed clinically

Exclusion criteria

Exclusion criteria: 1. Patients <18 years 2. Patients with hypersensitivity. 3. Pregnant or lactating women. 4. Patients who have participated in a drug study in the past 3 months. 5. Any condition which are likely to hinder the compliance with the protocol.

Design outcomes

Primary

Measure	Time frame
Improvement in Irritation in eye, foreign body sensation in eye, Light sensitivity of eye and Watering of eye.Timepoint: Day 0, Day 03 and Day 07.	—

Secondary

Measure	Time frame
Improvement in patientâ??s and physicianâ??s Global Assessment of treatment efficacy and tolerability.Timepoint: Day 0, Day 03 and Day 07.	—

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