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

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

Study Overview

• Status: Completed
• Conditions: Dry Eye Syndrome
• Intervention / Treatment: Drug: Carboxymethylcellulose and Glycerin based artificial tear; Drug: Carboxymethylcellulose

• Study Type: Interventional
• Enrollment (Actual): 228
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Carboxymethylcellulose and Glycerin based artificial tear	Drug: Carboxymethylcellulose and Glycerin based artificial tear; 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
Active Comparator: Carboxymethylcellulose based artificial tear	Drug: Carboxymethylcellulose; 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; Other Names: Refresh Plus®

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients Prescribed to Each Dosing Regimen at Day 14 and Day 60	Number of patients prescribed to each dosing regimen at Day 14 and Day 60. At each visit from Day 14 (the first post-operative visit) to Day 60, patients were prescribed to 1 to 4 dosing regimens based on the investigator's clinical evaluation. Dosing schedule options were: At least every 2 hours while awake, 6 to 8 times per day, 3 to 5 times per day, at 1 to 2 times per day.	Day 14, Day 60

Collaborators and Investigators

• Sponsor: Allergan

Study record dates

Study Major Dates

• Study Start: September 1, 2007
• Primary Completion (Actual): June 1, 2008
• Study Completion (Actual): June 1, 2008

Study Registration Dates

• First Submitted: October 12, 2007
• First Submitted That Met QC Criteria: October 15, 2007
• First Posted (Estimate): October 16, 2007

Study Record Updates

• Last Update Posted (Estimate): December 14, 2011
• Last Update Submitted That Met QC Criteria: November 9, 2011
• Last Verified: November 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Dry Eye Syndromes; Physiological Effects of Drugs; Gastrointestinal Agents; Protective Agents; Pharmaceutical Solutions; Laxatives; Cryoprotective Agents; Ophthalmic Solutions; Glycerol; Lubricant Eye Drops; Carboxymethylcellulose Sodium
• Other Study ID Numbers: AG9818-001