Evaluate the Safety and Efficacy of a New Artificial Tear for Use After LASIK Surgery - Full Text View

Purpose

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

Condition	Intervention
Dry Eye Syndrome	Drug: Carboxymethylcellulose and Glycerin based artificial tear Drug: Carboxymethylcellulose

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment

Resource links provided by NLM:

Genetics Home Reference related topics: keratitis-ichthyosis-deafness syndrome

Drug Information available for: Glycerin Carboxymethylcellulose sodium Hydroxypropyl methylcellulose Croscarmellose sodium

U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:

Post LASIK Dry Eye Symptoms as Measured by Ocular Surface Disease Index (OSDI©) Score at Day 90 [ Time Frame: Day 90 ] [ Designated as safety issue: No ]
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)).

Secondary Outcome Measures:

Patient Acceptability- Percentage of Patients Who Rated Artificial Tears (AT) as Acceptable at Day 90 [ Time Frame: Day 90 ] [ Designated as safety issue: No ]
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".
Patient Acceptability (Sensory) - Percentage of Patients Who Rated Artificial Tears (AT) as Acceptable at Day 90 [ Time Frame: Day 90 ] [ Designated as safety issue: No ]
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".
Best Corrected Visual Acuity (BCVA) Status at Day 90 [ Time Frame: Day 90 ] [ Designated as safety issue: No ]
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.
Change From Baseline of the Worse Eye in Corneal Topography as Measured by Pentacam at Day 90 [ Time Frame: Baseline, Day 90 ] [ Designated as safety issue: No ]
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.
Change From Baseline of the Worse Eye in Corneal Topography Measured by Humphrey Atlas at Day 90 [ Time Frame: Baseline, Day 90 ] [ Designated as safety issue: No ]
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.
Change From Baseline of Total Higher Order Aberration (HOA) of the Worse Eye at Day 90 [ Time Frame: Baseline, Day 90 ] [ Designated as safety issue: No ]
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.
Change From Baseline of the Worse Eye in Schirmer's Test at Day 90 [ Time Frame: Baseline, Day 90 ] [ Designated as safety issue: No ]
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.
Change From Baseline of the Worse Eye in Corneal Staining With Fluorescein at Day 90 [ Time Frame: Baseline, Day 90 ] [ Designated as safety issue: No ]
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).
Change From Baseline of the Worse Eye in Conjunctival Staining With Lissamine Green at Day 90 [ Time Frame: Baseline, Day 90 ] [ Designated as safety issue: No ]
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).
Change From Baseline of the Worse Eye in Tear Break-Up Time (TBUT) at Day 90 [ Time Frame: Baseline, Day 90 ] [ Designated as safety issue: No ]
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).
Change From Baseline in Study Product Usage at Day 90 [ Time Frame: Baseline, Day 90 ] [ Designated as safety issue: No ]
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).

Enrollment:	228
Study Start Date:	September 2007
Study Completion Date:	June 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Carboxymethylcellulose and Glycerin based artificial tear 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 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 Name: Refresh Plus®

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00544713

Locations

United States, California

San Diego, California, United States

Sponsors and Collaborators

Allergan

Investigators

Study Director:

Medical Director

Allergan

More Information

No publications provided

Responsible Party:	Allergan
ClinicalTrials.gov Identifier:	NCT00544713 History of Changes
Other Study ID Numbers:	AG9818-001
Study First Received:	October 12, 2007
Results First Received:	June 29, 2009
Last Updated:	November 9, 2011
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Dry Eye Syndromes
Keratoconjunctivitis Sicca
Lacrimal Apparatus Diseases
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases

Carboxymethylcellulose Sodium
Glycerol
Laxatives
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Cryoprotective Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013