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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00544713
• Date of registration: 12/10/2007
• Primary sponsor: Allergan
• Public title: Evaluate the Safety and Efficacy of a New Artificial Tear for Use After LASIK Surgery
• Date of first enrolment: September 2007
• Target sample size: 228
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00544713
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Medical Director
• Affiliation: Allergan

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Dry Eye Syndrome

Intervention(s)

Drug: Carboxymethylcellulose

Drug: Carboxymethylcellulose and Glycerin based artificial tear

Primary Outcome(s)

Post LASIK Dry Eye Symptoms as Measured by Ocular Surface Disease Index (OSDI©) Score at Day 90 [Time Frame: Day 90]

Secondary Outcome(s)

Best Corrected Visual Acuity (BCVA) Status at Day 90 [Time Frame: Day 90]

Change From Baseline in Study Product Usage at Day 90 [Time Frame: Baseline, Day 90]

Change From Baseline of the Worse Eye in Conjunctival Staining With Lissamine Green at Day 90 [Time Frame: Baseline, Day 90]

Change From Baseline of the Worse Eye in Corneal Staining With Fluorescein at Day 90 [Time Frame: Baseline, Day 90]

Change From Baseline of the Worse Eye in Corneal Topography as Measured by Pentacam at Day 90 [Time Frame: Baseline, Day 90]

Change From Baseline of the Worse Eye in Corneal Topography Measured by Humphrey Atlas at Day 90 [Time Frame: Baseline, Day 90]

Change From Baseline of the Worse Eye in Schirmer's Test at Day 90 [Time Frame: Baseline, Day 90]

Change From Baseline of the Worse Eye in Tear Break-Up Time (TBUT) at Day 90 [Time Frame: Baseline, Day 90]

Change From Baseline of Total Higher Order Aberration (HOA) of the Worse Eye at Day 90 [Time Frame: Baseline, Day 90]

Patient Acceptability (Sensory) - Percentage of Patients Who Rated Artificial Tears (AT) as Acceptable at Day 90 [Time Frame: Day 90]

Patient Acceptability- Percentage of Patients Who Rated Artificial Tears (AT) as Acceptable at Day 90 [Time Frame: Day 90]

Secondary ID(s)

AG9818-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors