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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01109056
Registration number
NCT01109056
Ethics application status
Date submitted
19/04/2010
Date registered
22/04/2010
Date last updated
25/06/2012
Titles & IDs
Public title
Safety and Efficacy of Cyclosporine Ophthalmic Emulsion in Patients With Primary Pterygium
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Scientific title
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Secondary ID [1]
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192371-019
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Pterygium
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Condition category
Condition code
Eye
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Diseases / disorders of the eye
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - cyclosporine ophthalmic emulsion 0.05%
Treatment: Drugs - Vehicle
Experimental: cyclosporine ophthalmic emulsion 0.05% - One drop in the study eye (or eyes) administered four times daily (QID)
Placebo Comparator: Vehicle - One drop in the study eye (or eyes) administered four times daily (QID)
Treatment: Drugs: cyclosporine ophthalmic emulsion 0.05%
One drop in the study eye (or eyes) administered four times daily (QID)
Treatment: Drugs: Vehicle
One drop in the study eye (or eyes) administered four times daily (QID)
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Pterygium Hyperemia Responders at Week 16
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Assessment method [1]
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Number of pterygium hyperemia responders at Week 16 as measured by the Pterygium Hyperemia Grading Scale. The Pterygium Hyperemia Grading Scale is a 6-point scale (0=absent, 1=trace, 2=mild, 3=moderate, 4=moderately severe, 5=severe). A responder is defined as a patient demonstrating at least a 2-grade decrease from baseline in pterygium hyperemia.
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Timepoint [1]
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Week 16
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Primary outcome [2]
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Change From Baseline in Severity Grade of Pterygium Hyperemia at Week 16
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Assessment method [2]
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Change from Baseline in Severity Grade of Pterygium Hyperemia at Week 16. The Pterygium Hyperemia Grading Scale is a 6-point scale (0=absent, 1=trace, 2=mild, 3=moderate, 4=moderately severe, 5=severe). A negative number change from baseline is an improvement and a positive number change from baseline is a worsening.
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Timepoint [2]
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Baseline, Week 16
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Secondary outcome [1]
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Change From Baseline in Ocular Surface Disease Index© (OSDI©) Questionnaire Score at Week 16
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Assessment method [1]
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Change from baseline in Ocular Surface Disease Index© (OSDI©) Questionnaire score at Week 16. The OSDI© is a 12-question survey for patients to document their dry eye disease symptoms. Each question is rated on a 5-point scale (0=none of the time and 4 = all of the time). The scores are totaled over the 12 questions and normalized/converted to a score of 0-100 (0=no disability and 100=complete disability). A negative number change from baseline represents an improvement.
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Timepoint [1]
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Baseline, Week 16
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Eligibility
Key inclusion criteria
- Have a pterygium in at least one eye that has not been previously removed with surgery
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Uncontrolled systemic disease
- Active eye disease
- Current or anticipated use of topical eye medications other than artificial tears.
- Anticipated wearing of contact lenses
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/06/2010
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/06/2011
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Sample size
Target
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Accrual to date
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Final
115
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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- Randwick
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Recruitment postcode(s) [1]
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- Randwick
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Country [2]
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Singapore
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State/province [2]
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Singapore
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Allergan
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This study will evaluate the safety and efficacy of Cyclosporine Ophthalmic Emulsion 0.05%
(RESTASIS®) in patients with primary pterygium (abnormal growth on surface of eye).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01109056
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Medical Director
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Address
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Allergan
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01109056
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