E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Ocular Symptoms Associated with Seasonal Allergic Rhinitis |
|
E.1.1.1 | Medical condition in easily understood language |
Ocular Symptoms Associated with Seasonal Allergic Rhinitis |
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E.1.1.2 | Therapeutic area | Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09] |
MedDRA Classification |
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 |
to demonstrate that a 14-day course of
FP200QD is superior to placebo in relieving ocular symptoms associated with AR as determined by mean change from baseline in subject-rated reflective total ocular symptom scores (rTOSS) |
|
E.2.2 | Secondary objectives of the trial |
to evaluate FP compared to placebo in
terms of:
Mean change from baseline in both the AM rTOSS and PM rTOSS;
Mean change from baseline in both the individual AM reflective symptom score and the PM reflective symptom score for each symptom of itching/burning, tearing/watering, redness;
Mean change from baseline in AM pre-dose Instantaneous Total Ocular Symptom Scores (iTOSS);
End-of-treatment assessment of response to therapy for ocular symptoms;
Impact of rhinitis on activities of daily living and overall well-being using the
Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) variables, overall scores, and individual domains.
Mean change from baseline in daily Reflective Nasal Congestion Symptom Score (rNCSS);
Objective assessment of conjunctival redness. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Consent/Assent
Aged at least 12 years at Visit 2 (Screening/Placebo Lead-in Visit).
Compliance
General Health
Diagnosis of seasonal allergic rhinitis
Allergic rhinitis symptom of at least moderate severity for randomization
The subject resided within a geographical environment where exposure to
mountain cedar pollen was significant during the entire study period.
Contraception |
|
E.4 | Principal exclusion criteria |
Pregnancy
Breast-feeding
Allergy/Intolerance
Nasal disorders
Disease
Infection
Impairments limiting participation
Medication
Clinical Study/Experimental Medication
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
Mean change from baseline in rTOSS for a 14-day course. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Mean change from baseline in both the AM rTOSS and PM rTOSS;
Mean change from baseline in both the individual AM reflective and PM reflective ocular symptom scores for each symptom of itching/burning, tearing/watering, redness;
Mean change from baseline in AM pre-dose iTOSS;
End-of-treatment assessment of response to therapy for ocular symptoms;
Impact of rhinitis on activities of daily living and overall well-being using the
MiniRQLQ variables, overall scores, and individual domains.
Mean change from baseline in daily rNCSS;
Objective assessment of conjunctival redness; |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
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 | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
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 | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
Will this trial be conducted at a single site globally?
| No |
E.8.4 | Will this trial be conducted at multiple sites globally? | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.2 | Trial being conducted completely outside of the EEA | Yes |
E.8.6.3 | Specify the countries outside of the EEA in which trial sites are planned |
|
E.8.7 | Trial has a data monitoring committee | No |
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.8.9.2 | In all countries concerned by the trial days | 14 |