A clinical Trial in patients with Vernal Keratoconjunctivitis. Clinical trial is to study efficacy, safety and tolerability of Tacrolimus Ophthalmic Suspension in comparison to Cyclosporine eye drops (reference product).

Phase 3

Completed

• Conditions: Health Condition 1: H108- Other conjunctivitisHealth Condition 2: null- Vernal Keratoconjunctivitis

• Registration Number: CTRI/2010/091/001456
• Lead Sponsor: Ajanta Pharma Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 200

Inclusion Criteria

1.Clinical diagnosis of Vernal keratoconjunctivitis confirmed by Laboratory evaluation (microscopic examination confirmed by slit lamp examination of eye)

2.Patients who had moderate or severe giant papillae 4 weeks prior to the start of study drug administration, even though they had received the treatment by anti-allergic ophthalmic drugs 1-2 approved for vernal keratoconjunctivitis.

3.Patients who tested positive for a type 1 allergic reaction in a skin test or antigen-specific immunogloblin E measurement that had been conducted within 1 year before patient registration. Patients were also eligible who tested positive for a type 1 allergic reaction revealed by such factors as eye discharge or eosinophils in conjuctival abrasion.

Exclusion Criteria

Criteria based on efficacy evaluation
-Patients who had received the following prohibited concomitant drugs within 2 weeks prior to the start of study drug administration: systemic administration of adrenocortical steroid agents, subconjunctival injection, and ophthalmic or systemic administration of immunosuppressants.
-Patients who could not discontinue receiving the following prohibited concomitant drugs at the start of study drug administration: ophthalmic administration of adrenocortical steroid agents, ocular vasoconstrictor, and ocular non-steroidal anti-inflammatory drugs.
-Patients who could not discontinue receiving the following restricted concomitant drugs at the start of study drug administration that the patients had started receiving within 4 weeks prior to the start of study drug administration: anti-allergic agents (oral and ophthalmic administration), anti-histaminic drugs (oral and ophthalmic administration), and topical adrenocortical steroid agents and Tacrolimus ointment.
-Patients who underwent cryosurgery or surgical excision of giant papillae of the eye(s) to which the study drug was to be instilled within 4 weeks prior to the start of study drug administration.
-Patients who were receiving desensitization therapy or immune modulation therapy.
-Patients whose eye(s) was/were to be instilled with the study drug but needed wearing contact lenses during the study drug administration period.
Criteria based on assurance and evaluation of safety
-Patients who underwent invasive surgical treatments in the eye(s) to which the study drug was/were to be instilled within 3 months prior to the start of study drug administration. (Non-invasive therapy and cryosurgery or surgical excision of the papillae were not applicable here.)
-Patients who underwent laser therapy in the eye(s) to which the study drug was/were to be instilled within 4 weeks prior to the start of study drug administration.
-Patients who had an infectious eye disease as a complication in the eye(s) to which the study drug was/were to be instilled.
-Patients who had cataract as a complication in the eye(s) to which the study drug was/were to be instilled, making it impossible to perform funduscopy by mydriasis.
-Expecting mothers, lactating mothers, or women wishing to become pregnant.
-Patients who were hypersensitive to drugs.
-Patients with malignant tumors either as a concomitant disease or a history. (Those patients were eligible in whom malignant tumors had not recurred more than for 10 years.)
-Patients in whom infectious diseases were systemically manifested as concomitant ones.
-Patients given the diagnosis of diabetes mellitus.
-Patients who had a concomitant disease one of such organs as the heart, kidney, liver, or pancreas, and received treatment requiring hospitalization.
-Patients who had participated in any other clinical or post-marketing studies (not only for study drugs but for medical devices) before submitting the informed consent.
-Other patients who in the opinion of the investigator/sub investigator were inappropriate for the study participation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified