A clinical Trial in patients with Seasonal Allergic conjunctivitis.Clinical trial is to study efficacy, safety and tolerability of Desonide ophthalmic solution in comparison to Ketorolac Tromethamine ophthalmic solution (reference product).

A Comparative, Randomized, Double blind, Multicentric, Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Desonide 0.25% ophthalmic solution vs. Ketorolac tromethamine 0.5% ophthalmic solution in patients with Seasonal Allergic conjunctivitis.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/000329

Enrollment

100

Registered

2010-04-06

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: H108- Other conjunctivitis Health Condition 2: null- Seasonal Allergic conjunctivitis

Interventions

Intervention1: Desonide 0.25% ophthalmic solution: Days 0-3: Two drops per eye four times a day. Days 4 to 6: one drop per eye four times a day. Days 7 to 14: one drop per eye three time

Eligibility

Inclusion criteria

Inclusion criteria: 1. History of seasonal allergic conjunctivitis. 2. Presence of bilateral ocular itching/conjunctival hyperemia (redness) at baseline. 3. Written informed consent to participate in the trial.

Exclusion criteria

Exclusion criteria: 1. Patients < 18 & > 60 years. 2. A history of hypersensitivity to corticosteroids. 3. Active bacterial or viral conjunctivitis or history of ocular herpes. 4. Presence or history of severe dry eye. 5. Use of contact lenses during the course of the study. 6. Bestcorrected visual acuity (Snellen) in either eye worse than 20/100. 7. History of ocular surgery or laser within the previous 6 months; 8. Use of topical (ocular) or systemic corticosteroids within 2 weeks before the start of the study; 9. Participation in a clinical trial with an investigation drug within 30 days proceeding day one of this study. 10. 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 and Day 14.	—

Secondary

Measure	Time frame
Global assessmentTimepoint: Day 14;Redness of eye, Ocular itching, eyelid swelling, tearing, photophobia, mucous discharge, foreign body sensationTimepoint: Day 0, Day 3, Day 7 and Day 14.;safety and tolerabilityTimepoint: Day 0,Day 3, Day 7 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