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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT00884585
First received: April 17, 2009
Last updated: November 2, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention Phase
Atopic Conjunctivitis
Drug: Cyclosporine Vehicle
Drug: Cyclosporine 0.010%
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Percentage of Treatment Responders [ Time Frame: Baseline, Month 2 ] [ Designated as safety issue: No ]
    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:
  • Percentage of Punctate Corneal Staining Responders [ Time Frame: Month 2 ] [ Designated as safety issue: 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 [ Time Frame: Baseline, Month 2 ] [ Designated as safety issue: 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 [ Time Frame: Baseline, Month 2 ] [ Designated as safety issue: 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.


Enrollment: 176
Study Start Date: May 2009
Study Completion Date: July 2011
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
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.
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.
Drug: Cyclosporine Vehicle
Placebo (cyclosporine vehicle) administered 4 times a day to the qualified eye(s) for 3 months.
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.

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00884585

Locations
United States, California
Bakersfield, California, United States
Australia, New South Wales
Randwick, New South Wales, Australia
Canada, Ontario
Ottawa, Ontario, Canada
Czech Republic
Prague, Czech Republic
France
Dijon, Burgundy, France
Germany
Munich, Bavaria, Germany
India
Bangalore, Karnataka, India
Israel
Tel Aviv, Israel
Italy
Rome, Italy
New Zealand
Wellington, New Zealand
Spain
Valladolid, Spain
United Kingdom
Newcastle-upon-tyne, Tyne and Wear, United Kingdom
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00884585     History of Changes
Other Study ID Numbers: 192371-016
Study First Received: April 17, 2009
Results First Received: September 27, 2012
Last Updated: November 2, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Conjunctivitis
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Ophthalmic Solutions
Cyclosporins
Cyclosporine
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on October 19, 2014