E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Atopic Keratoconjunctivitis (AKC)
Queratoconjuntivitis atópica (QCA) |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10023348 |
E.1.2 | Term | Keratoconjunctivitis |
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E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the efficacy and safety of COS 0.010% compared to its vehicle in the treatment of Atopic Keratoconjunctivitis (AKC). |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Male or female patients at least 12 years of age - Female of childbearing potential must use a reliable form of contraception throughout the study period. - A negative urine pregnancy test result at Screening (Day -14) and Baseline (Day 1) for women of childbearing potential. - Best-corrected Visual Acuity of 20/800 or better in both eyes. - Written informed consent has been obtained. - Written Data Protection Consent has been obtained. - Written documentation has been obtained in accordance with the relevant country and local privacy requirements, where applicable. - Ability to follow study instructions and likely to complete all required study visits. - Clinical diagnosis of AKC, in which each of the following have been documented in the ophthalmic and medical histories (each ophthalmic sign could have been present in either eye): Chronic blepharoconjunctivitis Bulbar conjunctival hyperemia Punctuate keratitis (punctuate corneal staining) Presence or documented history of upper tarsal papillary hypertrophy Presence or documented history of atopic dermatitis - Presence of all the following in the same eye for at least one eye: At least Grade 2 punctuate corneal staining on a scale of 0-5 At least Grade 1 bulbar conjunctival hyperemia on a scale of 0-3 A composite symptom score of at least 4 or more (The composite symptom score is the sum of the severity scores for Itching, Tearing, Ocular Discomfort, Photophobia, and Mucous Discharge scored on a scale of 0-3 with a composite range of 0-15.) - At least one of the following in the same eye meeting inclusion criteria #11: Stable doses of topical ophthalmic steroid for treatment of AKC during the 2 weeks prior to Baseline (Day 1) Or, Patient has required at least 4 weeks of steroid to treat any previous exacerbation of AKC Or, History of intolerance to topical ophthalmic steroid use (e.g., hypersensitivity, steroid response glaucoma). - Stable doses of topical ophthalmic or systemic mast cell stabilizers, antihistamines, NSAIDs, or any combination of these medications are allowed if on stable doses for 2 weeks prior to Baseline (Day 1) in the eligible eye. - Stable doses of topical calcineurin inhibitors (e.g. topical tacrolimus or topical pimecrolimus) for dermatological use are allowed if on stable doses for 4 weeks prior to Baseline (Day 1). However, they are not allowed on the ocular surface or ocular adnexa including eyelids. - Stable doses of systemic immunosuppressives or systemic steroids are allowed if on stable doses for 4 weeks prior to Baseline (Day 1) except those meeting Exclusion Criteria 4. Adjustments to nasal or inhaled steroids are allowed during the screening period. |
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E.4 | Principal exclusion criteria |
- Uncontrolled systemic disease (except for atopic dermatitis) - Female patients who are pregnant, nursing, or planning a pregnancy during the study - Use of contact lenses within 48 hours prior to Baseline (Day 1) or anticipated use of contact lenses during the study in either eye - Use of systemic or topical ophthalmic ciclosporin, systemic or topical ophthalmic tacrolimus, topical ophthalmic pimecrolimus (e.g., topical ophthalmic ciclosporin, tacrolimus, or pimecrolimus formulations prepared by pharmacists), or systemic sirolimus within 4 weeks prior to Baseline (Day 1) or anticipated use during the study in either eye - Use of topical calcineurin inhibitors (e.g. topical tacrolimus or topical pimecrolimus) on the ocular surface or ocular adnexa including eyelids within 4 weeks prior to Baseline (Day 1) or anticipated use during the study in either eye - Current enrollment in an investigational drug or device study or participation in such within 30 days prior to entry into this study - Known allergy or sensitivity to the study medication(s) or its components - Anticipated use of glaucoma medications or other chronic topical ophthalmic medications (except artificial tears and those meeting Inclusion Criteria 12, 13 or 14) - History of inflammatory corneal ulcers not related to AKC, herpetic keratitis, recent or recurrent uveitis, or other severe or serious ocular pathology or other medical condition in either eye that could result in the patient?s inability to safely complete the study. - Active ocular disease not related to AKC, (e.g., infectious corneal ulcers, herpetic keratitis, uveitis, or ocular infection) in either eye - Patient has a situation or condition, which in the investigator?s opinion, may put the patient at a significant risk, may confound the study result or may interfere significantly with the participation in the study. |
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E.5 End points |
E.5.1 | Primary end point(s) |
- Punctuate corneal staining score responders (defined as the proportion of patients with a 2 or more grade improvement in punctuate corneal staining) - Composite symptom score responders (defined as the proportion of patients with a 4 or more grade improvement in composite symptom score) |
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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 | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
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 | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
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.8.3 |
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.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 40 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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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
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 4 |
E.8.9.2 | In all countries concerned by the trial days | 0 |