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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Scientific title
Secondary ID [1] 0 0
192371-019
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pterygium 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
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)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Pterygium Hyperemia Responders at Week 16
Timepoint [1] 0 0
Week 16
Primary outcome [2] 0 0
Change From Baseline in Severity Grade of Pterygium Hyperemia at Week 16
Timepoint [2] 0 0
Baseline, Week 16
Secondary outcome [1] 0 0
Change From Baseline in Ocular Surface Disease Index© (OSDI©) Questionnaire Score at Week 16
Timepoint [1] 0 0
Baseline, Week 16

Eligibility
Key inclusion criteria
* Have a pterygium in at least one eye that has not been previously removed with surgery
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

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 2
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
1/06/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2011
Sample size
Target
Accrual to date
Final
115
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
Singapore
State/province [2] 0 0
Singapore

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

Ethics approval
Ethics application status

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).
Trial website
https://clinicaltrials.gov/study/NCT01109056
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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01109056