Health Condition 1: H108- Other conjunctivitis Health Condition 2: null- Vernal Keratoconjunctivitis
Conditions
Interventions
Intervention1: Tacrolimus Ophthalmic Suspension: 1-2 drops twice daily for 4 weeks
Control Intervention1: Cyclosporine eye drops: 1-2 drops twice daily for 4 weeks
Sponsors
Ajanta Pharma Ltd
Eligibility
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in Vernal Keratoconjunctivitis shall be assessed by microscopic examination at each of the visits.Timepoint: Day 1, 1st week, 2nd week, 3rd week and 4th week.;Improvement in Vernal Keratoconjunctivitis shall be assessed by microscopic examination at each of the visits.Timepoint: Day 1, 1st week, 2nd week, 3rd week and 4th week. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety and tolerabilityTimepoint: 4th week | — |
Countries
India
Contacts
Public ContactDr Shailesh Singh
Ajanta Pharma Ltd, Advent
Outcome results
None listed