CTRI/2010/091/001456
Completed
Phase 3
A clinical study to evaluate the efficacy, safety and tolerability of Tacrolimus Ophthalmic Suspension 0.1 % Vs. Cyclosporine eye drops 0.05 % in patients with Vernal Keratoconjunctivitis.
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Ajanta Pharma Ltd
- Enrollment
- 200
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
Similar Trials
Unknown
Phase 2
S-304 PAHJPRN-jRCT2080221493IPPON SHINYAKU CO., LTD. / Actelion Pharmaceuticals Japan Ltd.30
Not yet recruiting
Not Applicable
A clinical trial of Malbet capsules in adult patients with uncomplicated influenza.Health Condition 1: J118- Influenza due to unidentified influenza virus with other manifestationsCTRI/2023/10/058885Solar Herbo Pvt. Ltd.
Completed
Phase 4
effect of Kanak taila in reducing wrinkles and promoting skin brightening.CTRI/2021/09/036560Ms Ozone Pharmaceuticals Ltd50
Completed
Phase 2
se of Roselle in Bronchial asthma and MalnutritioHealth Condition 1: J454- Moderate persistent asthmaCTRI/2020/08/027013DXN Manufacturing India Pvt Ltd12
Completed
Phase 2
se of Noni juice in Bronchial asthma and malnutritioHealth Condition 1: J454- Moderate persistent asthmaCTRI/2020/08/027012DXN Manufacturing India Pvt Ltd12