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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01886690




Registration number
NCT01886690
Ethics application status
Date submitted
24/06/2013
Date registered
26/06/2013
Date last updated
16/04/2019

Titles & IDs
Public title
A Study to Compare the Safety and Efficacy of a New Eye Drop Formulation With REFRESH PLUS® in Participants Following LASIK Refractive Surgery
Scientific title
Secondary ID [1] 0 0
11002X-002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bilateral LASIK Surgery 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - carboxymethylcellulose sodium based new eye drop formulation
Treatment: Drugs - carboxymethylcellulose sodium based eye drops

Experimental: New Eye Drop Formulation - 1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation in each eye as per protocol for 90 days.

Active comparator: REFRESH PLUS® - 1 to 2 drops carboxymethylcellulose sodium based (REFRESH PLUS®) eye drops in each eye as per protocol for 90 days.


Treatment: Drugs: carboxymethylcellulose sodium based new eye drop formulation
1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation in each eye as per protocol for 90 days.

Treatment: Drugs: carboxymethylcellulose sodium based eye drops
1 to 2 drops carboxymethylcellulose sodium based (REFRESH PLUS®) eye drops in each eye as per protocol for 90 days.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Ocular Surface Disease Index© (OSDI) Score Using a 5-Point Scale
Timepoint [1] 0 0
Day 90
Secondary outcome [1] 0 0
Change From Baseline in Corneal Staining in the Worse Eye
Timepoint [1] 0 0
Baseline, Day 90
Secondary outcome [2] 0 0
Change From Baseline in Tear Break-up Time (TBUT) in the Worse Eye
Timepoint [2] 0 0
Baseline, Day 90
Secondary outcome [3] 0 0
Change From Baseline in the Schirmer Test in the Worse Eye
Timepoint [3] 0 0
Baseline, Day 90
Secondary outcome [4] 0 0
Change From Baseline in Uncorrected Visual Acuity in the Worse Eye
Timepoint [4] 0 0
Baseline, Day 90

Eligibility
Key inclusion criteria
-Patients scheduled for LASIK surgery in both eyes.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Any systemic medication use within 3 months of screening (including over the counter, herbal, prescription, or nutritional supplement) which may affect dry eye or vision
* Use of topical eye medication other than prescribed for use in pre- or post-operative care
* Use of RESTASIS® or other topical ophthalmic cyclosporine product within 6 months prior to Screening
* Eye infection, inflammation, or allergy
* Soft contact lenses in the previous 7 days or rigid contact lenses in the previous 30 days prior to LASIK surgery.

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 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
20/08/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
18/08/2014
Sample size
Target
Accrual to date
Final
148
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- New South Wales
Recruitment postcode(s) [1] 0 0
- New South Wales
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
British Columbia

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

Ethics approval
Ethics application status

Summary
Brief summary
This study will compare the safety and efficacy of a new eye drop formulation with REFRESH PLUS® in participants following LASIK surgery.
Trial website
https://clinicaltrials.gov/study/NCT01886690
Trial related presentations / publications
Wallerstein A, Jackson WB, Chambers J, Moezzi AM, Lin H, Simmons PA. Management of post-LASIK dry eye: a multicenter randomized comparison of a new multi-ingredient artificial tear to carboxymethylcellulose. Clin Ophthalmol. 2018 May 7;12:839-848. doi: 10.2147/OPTH.S163744. eCollection 2018.
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/NCT01886690