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Health Condition(s) or Problem
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Atopic Conjunctivitis
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Lay Summary
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This study evaluates the efficacy and safety of Cyclosporine 0.010% eye drops in the
treatment of Atopic Keratoconjunctivitis (chronic and severe inflammation of the eye). The
study consists of a double-masked phase, and open-labeled phase, and an open-labeled
maintenance phase. For the first 3 months of the study, patients will receive either masked
Cyclosporine 0.010% eye drops or vehicle four times daily; for the next 6 months, patients
may receive open-labeled Cyclosporine 0.010% eye drops four times daily. At month 9,
patients who are in remission, will be re-randomized to receive either open-labeled
Cyclosporine 0.010% eye drops four times daily or twice daily.
(from ClinicalTrials.gov)
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Who can enter the trial
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Inclusion Criteria:
- Have a clinical diagnosis of Atopic Keratoconjunctivitis (chronic and severe
inflammation of the eye)
- Be on stable doses of your current AKC medications for at least 2 weeks
Exclusion Criteria:
- You have used contact lenses within 48 hours of Day 1 or think you may have to wear
contact lenses during the study
- You are pregnant, breastfeeding, or planning to become pregnant during the study
- You have used a calcineurin inhibitors (e.g. topical tacrolimus or topical
pimecrolimus) on or around your eyes including eyelids within 4 weeks
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Who cannot enter the trial
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Inclusion Criteria:
- Have a clinical diagnosis of Atopic Keratoconjunctivitis (chronic and severe
inflammation of the eye)
- Be on stable doses of your current AKC medications for at least 2 weeks
Exclusion Criteria:
- You have used contact lenses within 48 hours of Day 1 or think you may have to wear
contact lenses during the study
- You are pregnant, breastfeeding, or planning to become pregnant during the study
- You have used a calcineurin inhibitors (e.g. topical tacrolimus or topical
pimecrolimus) on or around your eyes including eyelids within 4 weeks
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What will happen
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Drug; Cyclosporine Vehicle; Placebo (cyclosporine vehicle) administered 4 times a day to the qualified eye(s) for 3 months.; Placebo followed by COS; Drug; Cyclosporine 0.010%; Cyclosporine ophthalmic solution 0.010% administered 4 times a day to the qualified eye(s) for up to 12 months; at Month 9 the dose may be adjusted to 2 times a day.; Cyclosporine Ophthalmic Solution (COS) followed by COS; Placebo followed by COS
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Primary aim
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Percentage of Treatment Responders
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Secondary Aim
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Percentage of Punctate Corneal Staining Responders; Month 2; No; Punctate corneal staining responders defined as patients achieving a punctate corneal staining score of 0 or 1 in the study eye. Punctate corneal staining is assessed on a scale of 0 to 5 where 0 is =2 dots, 1 is >2 dots but = 10 dots, 2 is > 10 dots but = 32 dots, 3 is > 32 dots but = 100 dots (approximately), 4 is > 100 dots (approximately) but = 316 dots (approximately), and 5 is >316 dots (approximately) or ulcer/erosion.; Percentage of Patients With an Improvement in the Composite Symptom Score; Baseline, Month 2; No; Composite symptom score improvement is defined as a 4 or more grade decrease from baseline in composite symptom score in the study eye. The composite symptom score is based on 5 symptoms (itching, tearing, ocular discomfort, photophobia, mucous discharge). Each of the 5 symptoms is assessed on a scale of 0=absent to 3=severe. The composite symptom score is the sum of all 5 individual symptom scores, where 0 is no symptoms and 15 is the most severe symptoms.; Percentage of Patients With an Improvement in the Punctate Corneal Staining Score; Baseline, Month 2; No; Punctate corneal staining improvement is defined as a 1 or more grade decrease from baseline in the study eye. The punctate corneal staining score is assessed on a scale of 0 to 5 where 0 is =2 dots, 1 is >2 dots but = 10 dots, 2 is > 10 dots but = 32 dots, 3 is > 32 dots but = 100 dots (approximately), 4 is > 100 dots (approximately) but = 316 dots (approximately), and 5 is >316 dots (approximately) or ulcer/erosion.
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Participant Information Sheet
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Sorry, not currently available
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Website
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Sorry, not currently available
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Recruitment Status
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Completed
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Nation
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England
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Location
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Newcastle Upon Tyne
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