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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/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
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Scientific title
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Secondary ID [1]
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11002X-002
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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:
Bilateral LASIK Surgery
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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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.
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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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Ocular Surface Disease Index© (OSDI) Score Using a 5-Point Scale
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Assessment method [1]
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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).
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Timepoint [1]
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Day 90
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Secondary outcome [1]
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Change From Baseline in Corneal Staining in the Worse Eye
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Assessment method [1]
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The cornea is the transparent front part of the eye which covers the iris and pupil. Corneal staining in the worse eye following administration of fluorescein dye in the eye is graded using a 6-point scale (0=no staining, 5=severe staining) over 5 areas of the clear central part of the eye for a minimum score of 0 and maximum score of 25. The higher the grade score, the worse the dry eye condition. A negative change from baseline represents a decrease in corneal staining (improvement) and a positive change from baseline represents an increase in corneal staining (worsening).
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Timepoint [1]
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Baseline, Day 90
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Secondary outcome [2]
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Change From Baseline in Tear Break-up Time (TBUT) in the Worse Eye
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Assessment method [2]
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TBUT is the time required for dry spots to appear on the surface of the eye after blinking in the worse eye. The longer it takes, the more stable the tear film. A short TBUT is a sign of poor tear film. A positive number change from baseline indicates an increase in TBUT (improvement) and a negative number change from baseline indicates a decrease in TBUT (worsening).
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Timepoint [2]
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Baseline, Day 90
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Secondary outcome [3]
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Change From Baseline in the Schirmer Test in the Worse Eye
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Assessment method [3]
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The Schirmer's Test measures the rate of the secretion of tears produced by the eye over 5 minutes in the worse eye. The results indicate the presence of dry eye (Normal = greater than or equal to 10 millimeters (mm) of tears, Dry Eye = less than 10 mm of tears). The smaller the number, the more severe the dry eye. A positive number change from baseline indicates an increase in tears (improvement) and a negative number change from baseline indicates a decrease in tears (worsening).
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Timepoint [3]
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Baseline, Day 90
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Secondary outcome [4]
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Change From Baseline in Uncorrected Visual Acuity in the Worse Eye
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Assessment method [4]
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Uncorrected visual acuity in the worse eye is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) without corrective lenses. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). A positive number change from baseline in the number of letters read correctly indicates an improvement and a negative number change from baseline indicates a worsening.
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Timepoint [4]
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Baseline, Day 90
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Eligibility
Key inclusion criteria
-Patients scheduled for LASIK surgery in both eyes.
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Minimum age
18
Years
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Maximum age
60
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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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.
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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 analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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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
20/08/2013
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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
18/08/2014
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Sample size
Target
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Accrual to date
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Final
148
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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- New South Wales
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Recruitment postcode(s) [1]
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- New South Wales
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Recruitment outside Australia
Country [1]
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Canada
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State/province [1]
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British Columbia
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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 compare the safety and efficacy of a new eye drop formulation with REFRESH
PLUS® in participants following LASIK surgery.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01886690
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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.
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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/NCT01886690
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