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

Allergan

Status: Completed

Conditions: Dry Eye Syndrome

Treatments: Drug: Carboxymethylcellulose; Drug: Carboxymethylcellulose and Glycerin based artificial tear

Study type: Interventional

Funder types: Industry

Identifiers

NCT00544713

AG9818-001

Details and patient eligibility

About

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

Enrollment: 228 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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228 participants in 2 patient groups

Carboxymethylcellulose and Glycerin based artificial tear

Experimental group

Description:

Carboxymethylcellulose and Glycerin based artificial tear

Treatment:

Drug: Carboxymethylcellulose and Glycerin based artificial tear

Carboxymethylcellulose based artificial tear

Active Comparator group

Description:

Carboxymethylcellulose based artificial tear

Treatment:

Drug: Carboxymethylcellulose