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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00884585




Registration number
NCT00884585
Ethics application status
Date submitted
17/04/2009
Date registered
17/04/2009
Date last updated
2/11/2012

Titles & IDs
Public title
Efficacy and Safety Study of Cyclosporine 0.010% to Treat Atopic Keratoconjunctivitis
Scientific title
Secondary ID [1] 0 0
192371-016
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atopic Conjunctivitis 0 0
Atopic Conjunctivitis 0 0
Atopic Conjunctivitis 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye
Inflammatory and Immune System 0 0 0 0
Allergies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Cyclosporine Vehicle
Treatment: Drugs - Cyclosporine 0.010%
Treatment: Drugs - Cyclosporine Vehicle
Treatment: Drugs - Cyclosporine 0.010%
Treatment: Drugs - Cyclosporine Vehicle
Treatment: Drugs - Cyclosporine 0.010%

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.

Other: 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.

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.

Other: 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.

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.

Other: 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.


Treatment: Drugs: Cyclosporine Vehicle
Placebo (cyclosporine vehicle) administered 4 times a day to the qualified eye(s) for 3 months.

Treatment: Drugs: 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.

Treatment: Drugs: Cyclosporine Vehicle
Placebo (cyclosporine vehicle) administered 4 times a day to the qualified eye(s) for 3 months.

Treatment: Drugs: 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.

Treatment: Drugs: Cyclosporine Vehicle
Placebo (cyclosporine vehicle) administered 4 times a day to the qualified eye(s) for 3 months.

Treatment: Drugs: 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 code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Treatment Responders - 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).
Timepoint [1] 0 0
Baseline, Month 2
Primary outcome [2] 0 0
Percentage of Treatment Responders - 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).
Timepoint [2] 0 0
Baseline, Month 2
Primary outcome [3] 0 0
Percentage of Treatment Responders - 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).
Timepoint [3] 0 0
Baseline, Month 2
Secondary outcome [1] 0 0
Percentage of Punctate Corneal Staining Responders - 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.
Timepoint [1] 0 0
Month 2
Secondary outcome [2] 0 0
Percentage of Patients With an Improvement in the Composite Symptom Score - 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.
Timepoint [2] 0 0
Baseline, Month 2
Secondary outcome [3] 0 0
Percentage of Patients With an Improvement in the Punctate Corneal Staining Score - 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.
Timepoint [3] 0 0
Baseline, Month 2
Secondary outcome [4] 0 0
Percentage of Punctate Corneal Staining Responders - 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.
Timepoint [4] 0 0
Month 2
Secondary outcome [5] 0 0
Percentage of Patients With an Improvement in the Composite Symptom Score - 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.
Timepoint [5] 0 0
Baseline, Month 2
Secondary outcome [6] 0 0
Percentage of Patients With an Improvement in the Punctate Corneal Staining Score - 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.
Timepoint [6] 0 0
Baseline, Month 2
Secondary outcome [7] 0 0
Percentage of Punctate Corneal Staining Responders - 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.
Timepoint [7] 0 0
Month 2
Secondary outcome [8] 0 0
Percentage of Patients With an Improvement in the Composite Symptom Score - 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.
Timepoint [8] 0 0
Baseline, Month 2
Secondary outcome [9] 0 0
Percentage of Patients With an Improvement in the Punctate Corneal Staining Score - 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.
Timepoint [9] 0 0
Baseline, Month 2

Eligibility
Key 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
Minimum age
12 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
- Randwick
Recruitment postcode(s) [1] 0 0
- Randwick
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
Canada
State/province [2] 0 0
Ontario
Country [3] 0 0
Czech Republic
State/province [3] 0 0
Prague
Country [4] 0 0
France
State/province [4] 0 0
Burgundy
Country [5] 0 0
Germany
State/province [5] 0 0
Bavaria
Country [6] 0 0
India
State/province [6] 0 0
Karnataka
Country [7] 0 0
Israel
State/province [7] 0 0
Tel Aviv
Country [8] 0 0
Italy
State/province [8] 0 0
Rome
Country [9] 0 0
New Zealand
State/province [9] 0 0
Wellington
Country [10] 0 0
Spain
State/province [10] 0 0
Valladolid
Country [11] 0 0
United Kingdom
State/province [11] 0 0
Tyne and Wear

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Allergan
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT00884585
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Allergan
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications