A Multicenter, Randomized, Double-Masked, Parallel-Group Study Evaluating the Efficacy and Safety of Cyclosporine Ophthalmic Solution 0.010% Compared with its Vehicle Administered QID for 3 months Followed by a 9 Month Open-Label Phase in Patients with Atopic Keratoconjunctivitis. Estudio multicéntrico, aleatorizado, doble ciego, de grupos paralelos para evaluar la eficacia y seguridad de Ciclosporina Solución oftálmica 0,010% en comparación con su vehículo administrada cuatro veces al día durante 3 meses, seguido de una fase abierta de 9 meses en pacientes con queratoconjuntivitis atópica.
- Conditions
- Atopic Keratoconjunctivitis (AKC) Queratoconjuntivitis atópica (QCA)MedDRA version: 9.1Level: LLTClassification code 10023348Term: Keratoconjunctivitis
- Registration Number
- EUCTR2009-012446-23-ES
- Lead Sponsor
- Allergan Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 124
- 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.
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
- 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method