Efficacy and Safety Study of Cyclosporine 0.010% to Treat Atopic Keratoconjunctivitis

Phase 3

Completed

• Conditions: Atopic Conjunctivitis
• Interventions: Drug: Cyclosporine 0.010%; Drug: Cyclosporine Vehicle

• Registration Number: NCT00884585
• Lead Sponsor: Allergan

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-04-17
• Study First Submitted QC: 2009-04-17
• Study First Posted: 2009-04-21
• Study Start: 2009-05
• Primary Completion: 2010-10
• Study Completion: 2011-07
• Disposition First Submitted: 2012-01-26
• Disposition First Submitted QC: 2012-01-26
• Disposition First Posted: 2012-01-30
• Results First Submitted: 2012-09-27
• Status Verified: 2012-11
• Results First Submitted QC: 2012-11-02
• Last Update Submitted: 2012-11-02
• Results First Posted: 2012-11-04
• Last Update Posted: 2012-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 176

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cyclosporine Ophthalmic Solution (COS) followed by COS	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.
Placebo followed by COS	Cyclosporine Vehicle	Placebo (cyclosporine vehicle) administered 4 times a day to the qualified eye(s) for 3 months followed by cyclosporine ophthalmic solution 0.010% up to 9 additional months; at Month 9 the dose may be adjusted to 2 times a day.
Placebo followed by COS	Cyclosporine 0.010%	Placebo (cyclosporine vehicle) administered 4 times a day to the qualified eye(s) for 3 months followed by cyclosporine ophthalmic solution 0.010% up to 9 additional months; at Month 9 the dose may be adjusted to 2 times a day.

Primary Outcome Measures

Name	Time	Method
Percentage of Treatment Responders	Baseline, Month 2	Treatment responders are defined as patients with a ≥ 1 grade improvement from baseline in punctate corneal staining score and a ≥ 4 grade improvement from baseline in composite symptom score in the study eye. The punctate corneal staining score is assessed on a scale of 0 to 5 (0 is ≤2 dots and 5 is \>316 dots (approximately) or ulcer/erosion). The composite symptom score is based on 5 symptoms (itching, tearing, ocular discomfort, photophobia, mucous discharge). The composite symptom score (0 to 15) is the sum of 5 symptoms (each symptom is assessed on a scale of 0=absent to 3=severe).

Secondary Outcome Measures

Name	Time	Method
Percentage of Punctate Corneal Staining Responders	Month 2	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	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	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.