SYF28bb83f7ab494a2a85cd27972be26430Registry ID: 2023-503185-23-00|UnknownPhase 3Results
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Secondary identifiers
interventional
N/A
1 country
8
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
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February 3, 2023
Actual (reported)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.
Hospital Santa Maria Della Misericordia
Perugia, 06129, Italy
Azienda Sociosanitaria Territoriale Santi Paolo E Carlo
Milan, 20142, Italy
Policlinico Casilino (Gruppo Eurosaità spa)
Italy
Rocco Carmelo Pavese
First Submitted
February 3, 2023
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Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.
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IRCCS Fondazione G.B. Bietti
Italy
IRCCS Azienda Ospedaliero-Universitaria Di Bologna
Bologna, 40138, Italy
Azienda Ospedaliera Universitaria Federico II Di Napoli
Naples, 80131, Italy
Ospedale San Raffaele S.r.l.
Milan, 20132, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, 00168, Italy