Patients with seasonal allergic conjunctivitis and history of ocular allergies for at least 2 years. MedDRA version: 6.1 Level: PT Classification code 10010744
Conditions
Interventions
Trade Name: KETOFTIL*COLL FL 10ML 0,05%
Pharmaceutical Form: Eye drops, solution
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 25-
Trade Name: ZADITEN
Pharma
Sponsors
FARMIGEA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Written informed consent. 2.Outpatients, male or female, aged 12 years or older. 3.History of ocular allergies for at least 2 years, documented, within the past 12 months, by positive skin testing prick or intradermal methods or by adequately validated in vitro tests for specific IgE e.g., RAST, PRIST to the relevant allergens for the geographic area of the study or for the local environment. 4.Ocular symptoms of allergy stared at least 24 hours preceding enrolment and having a self-rated sum score equal of more than 6 for itching, tearing and redness. 5.Ability to self-instil ophthalmic solutions Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.Pregnant or lactating women, or women of childbearing age not using an acceptable method of contraception. 2.History of glaucoma. 3.Known history of retinal detachment, diabetic retinopathy, or progressive retinal disease. 4.Patients with suspected or known hypersensitivity to the study products or their excipients. 5.Patients already enrolled in this study or patients who have received any other investigational drug within 1 month prior to study entry, or have such treatment planned for the study period. 6.Presence of active ocular infection. 7.Pre-treatment 24 hours with antibiotic for any ophthalmic disease. 8.Documented evidence of acute or significant chronic sinusitis. 9.Clinically significant blepharitis, follicular conjunctivitis, iritis or pterygium. 10.History or diagnosis of dry eye. 11.History or diagnosis of vernal kerato-conjunctivitis VKC or atopic kerato-conjunctivitis AKC . 12.Ocular surgical intervention within 3 months or during the study. 13.History of refractive surgery within 6 months or during the study. 14.Use of contact lenses within 2 days before randomization. 15.Topical ophthalmic and/or nasal medications suspended after the following washout periods or their systemic formulation not in a stable therapeutic regime after the following washout periods.Corticosteroids 1 month; Mastcell stabilizers 2 weeks Loratadine Clarytin 2 weeks; Decongestants 3 days; Antihistamines 3 days 16.Anti-allergy immunotherapy desensitising subjects with increase of allergen challenges in the previous two years or still ongoing. 17.Immunotherapy, including systemic corticosteroids, started or changed in dose, less than one month preceding enrolment. 18.Chronic use of concomitant medications e.g., tricyclic antidepressants that would affect assessment of the effectiveness of the study medication. 19.Patients requiring treatment during the study period with drugs not permitted by the clinical study protocol. 20.Patients presenting poor reliability e.g. history of alcohol or drug abuse, bad mental conditions, planned travel outside the study area for a substantial portion of the study period .
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: THE COMPARISON BETWEEN TREATMENT GROUPS, OF THE CHANGE FROM BASELINE IN THE REFLECTIVE TOTAL OCULAR SYMPTOM SCORE TOSS .;Secondary Objective: -Comparison of the change from baseline in each reflective and instantaneous self-rated symptom score hitching, tearing and redness between treatment groups and the assessment of the time course of the effect. -Comparison of the change from baseline in the scores observed by the investigator of redness, eyelid swelling and chemosis. -Comparison of the responder rate as judged by subject and by the investigator. -Comparison of the global efficacy, safety and tolerability of the two dosages of Ketotifen fumarate;Primary end point(s): THE COMPARISON BETWEEN TREATMENT GROUPS, OF THE CHANGE FROM BASELINE IN THE REFLECTIVE TOTAL OCULAR SYMPTOM SCORE TOSS . | — |
Countries
Italy
Outcome results
None listed