MULTICENTRE, RANDOMISED, DOUBLE-BLIND, VEHICLE AND ACTIVE-CONTROLLED PHASE III STUDY EVALUATING THE EFFICACY AND SAFETY OF KETOTIFEN OPHTHALMIC SOLUTION 0.5 MG/ML COMPARED TO VEHICLE AND KETOFTIL (KETOTIFEN OPHTHALMIC SOLUTION 0.5 MG/ML) FOR THE TREATMENT OF SEASONAL ALLERGIC CONJUNCTIVITIS.

SEASONAL ALLERGIC CONJUNCTIVITIS

To evaluate Ocular Itching between V1 (baseline) and V5 (14 days) later Ketotifen/ Ketoftil®/Placebo administrations. Ocular itching scores will be self-assessed by the participants using a 5-point scale.

To evaluate Conjunctival Redness at 30 minutes, 2 days, 7 days, 14 days later the first Ketotifen/Ketoftil®/Placebo administrations. Conjunctival redness will be assessed by the Investigator using the Efron scale., To evaluate tearing and eyelid swelling at 30 minutes, 2 days, 7 days, 14 days later the first Ketotifen/Ketoftil®/Placebo administrations. Tearing and eye swelling will be assessed by the Investigator using a 4-point scale, To evaluate conjunctival chemosis at 30 minutes, 2 days, 7 days, 14 days later the first Ketotifen/Ketoftil®/Placebo administrations. Conjunctival chemosis will be assessed by the Investigator using a 3-point scale., To evaluate the product tolerability at 30 minutes, 2 days, 7 days, 14 days later the first Ketotifen/Ketoftil®/Placebo administrations. Product tolerability will be assessed by the Investigator using the Visual Analog Scale (VAS)., Quantitative and Qualitative Evaluation of Safety in terms of adverse events reported.

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