Evaluate the Safety and Efficacy of a New Artificial Tear for Use After LASIK Surgery

Study Overview
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Brief Summary
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This study will evaluate the safety and efficacy of a new artificial tear for the treatment of dry eye that may occur after LASIK surgery

Conditions
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Dry Eye Syndrome

Intervention / Treatment
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* Drug: Carboxymethylcellulose and Glycerin based artificial tear
* Drug: Carboxymethylcellulose


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Candidate for bilateral LASIK surgery for myopia correction in the range of -1.00 to -8.00 diopters Exclusion Criteria: Dry eye signs and symptoms Preoperative soft or rigid contact lens wear within last 7 or 30 days, respectively Pregnancy or planning pregnancy Uncontrolled systemic disease Use of systemic medications affecting dry eye

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Carboxymethylcellulose and Glycerin based artificial tear<br>Carboxymethylcellulose and Glycerin based artificial tear | Drug: Carboxymethylcellulose and Glycerin based artificial tear<br>* As directed by Investigator at the end of each study visit: 1 to 2 drops in each eye, 1 to 2 times a day up to every hour while awake<br>|
| Active Comparator: Carboxymethylcellulose based artificial tear<br>Carboxymethylcellulose based artificial tear | Drug: Carboxymethylcellulose<br>* As directed by Investigator at the end of each study visit: 1 to 2 drops in each eye, 1 to 2 times a day up to every hour while awake<br>* Other names: Refresh Plus®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post LASIK Dry Eye Symptoms as Measured by Ocular Surface Disease Index (OSDI©) Score at Day 90 | Measured on 12 domains (categories); a 5-point scale for each domain (0 = best, no dry eye symptoms, 4 = worst, constant dry eye symptoms). Sum of the domain scores is normalized (standardized) to a severity scale of 0-100 (0 = no symptoms (best score), 100 = maximum severity (worst score)). | Day 90 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Acceptability- Percentage of Patients Who Rated Artificial Tears (AT) as Acceptable at Day 90 | A questionnaire was administered to all patients to evaluate the acceptability of the Artificial Tears (referred to as AT). Percentage of patients responding either Agree or Strongly Agree at day 90 was tabulated. The potential response categories included Strongly Agree, Agree, Neither Agree Nor Disagree, Disagree and Strongly Disagree. | Day 90 | 
| Patient Acceptability (Sensory) - Percentage of Patients Who Rated Artificial Tears (AT) as Acceptable at Day 90 | A patient acceptability - sensory questionnaire was administered to all patients to evaluate the acceptability of the Artificial Tears (AT). Percentage of patients responding either Agree or Strongly Agree at day 90 was tabulated. The potential response categories included Strongly Agree, Agree, Neither Agree Nor Disagree, Disagree and Strongly Disagree. | Day 90 | 
| Best Corrected Visual Acuity (BCVA) Status at Day 90 | BCVA status at Day 90 reported as the number of patients whose scores were either Better, No Change, or Worse than their scores at baseline. The status was tabulated as number of lines read correctly at Day 90 minus the number of lines read correctly at baseline. Better equals increase of 2 lines or more; No Change equals change between -2 to +2 lines; Worse equals decrease of 2 lines or more. BCVA is measured using a special eye chart a nd is reported as the number of lines (5 letters per line) read correctly. | Day 90 | 
| Change From Baseline of the Worse Eye in Corneal Topography as Measured by Pentacam at Day 90 | Change from Baseline in corneal topography of the worse eye as measured using a Pentacam system which calculates a number. Corneal topography is a non-invasive medical imaging technique for mapping the surface of the eye. The Pentacam system measures the pupil and anterior segment (the front part of the eye) which provides a range from 10 (best) to 60 (worst). A negative number change from baseline indicates an improvement. | Baseline, Day 90 | 
| Change From Baseline of the Worse Eye in Corneal Topography Measured by Humphrey Atlas at Day 90 | Change from Baseline in corneal topography of the worse eye as measured by a Humphrey Atlas system which calculates a number. Corneal topography is anon-invasive medical imaging technique for mapping the surface curvature of the cornea (the outer structure of the eye). The higher the number the more irregular the cornea. A Humphrey Atlas system detects irregular conditions in the cornea with a range from 0 = best to 2.5 = worst. A negative number change from baseline indicates an improvement. | Baseline, Day 90 | 
| Change From Baseline of Total Higher Order Aberration (HOA) of the Worse Eye at Day 90 | Change from Baseline in total HOA of the worse eye. The total HOA number is measured using a machine that calculates and detects changes in the cornea which could occur post Lasik surgery. A negative number change from baseline indicates an improvement. | Baseline, Day 90 | 
| Change From Baseline of the Worse Eye in Schirmer's Test at Day 90 | Change from baseline in Schirmer's Test results at Day 90 in the worse eye. The Schirmer's Test measures the rate of the secretion of tears produced by the eye over 5 minutes. The results indicate the presence of dry eye (Normal = greater than or equal to 15 millimeters (mm) of tears, Dry Eye = less than 15 mm of tears). The smaller the number, the more severe the dry eye. | Baseline, Day 90 | 
| Change From Baseline of the Worse Eye in Corneal Staining With Fluorescein at Day 90 | Change from Baseline in corneal staining of the worse eye at Day 90. Sum of corneal staining over 5 zones; each zone was measured on a modified Oxford Scheme (0 = no staining and 5 = severe staining), for a minimum score of 0 and a 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). | Baseline, Day 90 | 
| Change From Baseline of the Worse Eye in Conjunctival Staining With Lissamine Green at Day 90 | Change from Baseline in conjunctival staining of the worse eye using Lissamine Green staining procedure. Sum of conjunctival staining over 6 zones; each zone was measured on a modified Oxford Scheme (0 = no staining and 5 = severe staining), with a minimum score of 0 and a maximum score of 30. The higher the grade score, the worse dry eye condition. A negative number change from baseline represents a decrease in corneal staining (improvement). | Baseline, Day 90 | 
| Change From Baseline of the Worse Eye in Tear Break-Up Time (TBUT) at Day 90 | Change from Baseline in TBUT of the worse eye at Day 90. TBUT is the time required for dry spots to appear on the surface of the eye after blinking. 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). | Baseline, Day 90 | 
| Change From Baseline in Study Product Usage at Day 90 | Change from baseline in the study product usage (average number of uses per day) at Day 90. A negative number change from baseline indicates a reduction in eye drop usage (improvement). | Baseline, Day 90 |