Health Condition 1: H108- Other conjunctivitis Health Condition 2: null- Subjects suffering from Allergic Conjunctivitis
Conditions
Interventions
Intervention1: Bepotastine besilate 1.5%ophthalmic solution: Instill one drop into the affected eye(s) twice a day for 3 weeks
Control Intervention1: Olopatadine hydrochloride 0.1% ophthalmic solution
Sponsors
Ajanta Pharma Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Subject with sign and symptoms of allergic conjunctivitis like ocular itching, eye lid swelling, tearing, photophobia, watery discharge, diagnosis of allergic conjunctivitis will be confirmed by conjunctival smear examination. 2.Freshly diagnosed subject or Subjects who are previously diagnosed and on treatment of allergic conjunctivitis will undergo for 3 days wash out period 3.Subject willing to sign informed consent form (ICF) prior to any screening procedure. For Minor subject (age below 18yrs) LAR (Legally Acceptable Representative) should be taken with assent.
Exclusion criteria
Exclusion criteria: 1.Subjects who took systemic administration of corticosteroids or immunosuppressive agents, or used ophthalmic ointments of corticosteroids within 1 week before instillation of the investigational drugs. 2.Use of disallowed medications during the period indicated prior to study enrollment or during the study. 3.Subject with dry eyes should be excluded from the trial 4.Subject with Schirmer 10 should be excluded from the study. 5.Subject who are blind or subject with single eye. 6.Subjects who have planned surgery during trial period. 7.Subject with Vernal Keratoconjunctivitis should be excluded from the trial. 8.Subjects having corneal epithelial detachment or corneal ulcer in the target eye. 9.Subjects who are required to wear contact lens during the study period. 10.Subjects who are pregnant or may be pregnant or lactating. 11.Subjects who have participated in other clinical studies within 3 months. 12.Any ocular condition that, in the opinion of the investigator, could affect the subjectâ??s safety or trial parameters. 13.Known contraindications or sensitivities to the study medication or its components. 14.Other patients who in the opinion of the investigator/sub investigator were inappropriate for the study participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of Bepotastine besilate ophthalmic solution Vs. Olopatadine hydrochloride ophthalmic solution in Subjects Suffering from Allergic Conjunctivitis.Timepoint: Day 0,1 week,2 week and 3 week. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the safety and tolerability of Bepotastine besilate ophthalmic solution Vs. Olopatadine hydrochloride ophthalmic solution. Global assessment of study medications by Subjects and Investigators. Timepoint: Day 0,1 week,2 week and 3 week. | — |
Countries
India
Contacts
Public ContactDr Shailesh Singh
Ajanta pharma Ltd
Outcome results
None listed