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

NCT ID: NCT00884585

Last Updated: 2012-11-05

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

176 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2011-07-31

Brief 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.

Detailed Description

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Conditions

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Atopic Conjunctivitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Cyclosporine Ophthalmic Solution (COS) followed by COS

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.

Group Type EXPERIMENTAL

Cyclosporine 0.010%

Intervention Type DRUG

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

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.

Group Type OTHER

Cyclosporine Vehicle

Intervention Type DRUG

Placebo (cyclosporine vehicle) administered 4 times a day to the qualified eye(s) for 3 months.

Cyclosporine 0.010%

Intervention Type DRUG

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.

Interventions

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Cyclosporine Vehicle

Placebo (cyclosporine vehicle) administered 4 times a day to the qualified eye(s) for 3 months.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Allergan

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Allergan

Locations

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Bakersfield, California, United States

Site Status

Randwick, New South Wales, Australia

Site Status

Ottawa, Ontario, Canada

Site Status

Prague, , Czechia

Site Status

Dijon, Burgundy, France

Site Status

Munich, Bavaria, Germany

Site Status

Bangalore, Karnataka, India

Site Status

Tel Aviv, , Israel

Site Status

Rome, , Italy

Site Status

Wellington, , New Zealand

Site Status

Valladolid, , Spain

Site Status

Newcastle upon Tyne, Tyne and Wear, United Kingdom

Site Status

Countries

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United States Australia Canada Czechia France Germany India Israel Italy New Zealand Spain United Kingdom

Other Identifiers

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192371-016

Identifier Type: -

Identifier Source: org_study_id