Efficacy of Cyclosporine for the Prevention and Treatment of Dry Eye Symptoms Following LASIK or Photorefractive Keratectomy

Innovative Medical

Status and phase: Completed; Phase 4

Conditions: Dry Eye Syndromes

Treatments: Drug: Cyclosporine, Refresh Plus

Study type: Interventional

Funder types: Industry

Identifiers

NCT00349440

1121

Details and patient eligibility

About

The purpose of this study is to evaluate the effect of topical cyclosporine ophthalmic solution 0.05% (Restasis, Allergan) on the signs and symptoms of dry eye in patients undergoing LASIK or photorefractive keratectomy (PRK).

Enrollment: 93 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Males or females > 18 years old
• Mild-moderate symptoms of dry eye prior to surgery
• Scheduled to undergo bilateral LASIK or PRK
• Likely to complete all study visits and able to provide informed consent

Exclusion criteria

• Prior use of topical cyclosporine within the last 1 year
• Known contraindications to any study medication or ingredients
• Female of child bearing potential not using reliable methods of birth control, or pregnant or lactating females.
• Ocular disorders
• Active ocular diseases or uncontrolled systemic disease
• Active ocular allergies

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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93 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Treatment:

Drug: Cyclosporine, Refresh Plus

2

Placebo Comparator group

Treatment:

Drug: Cyclosporine, Refresh Plus