E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with seasonal allergic conjunctivitis and history of ocular allergies for at least 2 years. |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 6.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10010744 |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
THE COMPARISON BETWEEN TREATMENT GROUPS, OF THE CHANGE FROM BASELINE IN THE REFLECTIVE TOTAL OCULAR SYMPTOM SCORE TOSS . |
|
E.2.2 | Secondary objectives of the trial |
-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 |
|
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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 |
|
E.4 | Principal 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 . |
|
E.5 End points |
E.5.1 | Primary end point(s) |
THE COMPARISON BETWEEN TREATMENT GROUPS, OF THE CHANGE FROM BASELINE IN THE REFLECTIVE TOTAL OCULAR SYMPTOM SCORE TOSS . |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 5 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 5 |