Safety and Efficacy Study of Cyclosporine Ophthalmic Emulsion in Post-LASIK Patients

Allergan

Status and phase: Completed; Phase 2

Conditions: Dry Eye Syndromes

Treatments: Drug: Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®); Drug: Artificial Tears REFRESH ENDURA®

Study type: Interventional

Funder types: Industry

Identifiers

NCT00611403

192371-014

Details and patient eligibility

About

This study will evaluate the safety and efficacy of cyclosporine ophthalmic emulsion administered twice daily following LASIK surgery

Enrollment: 137 patients

Sex: All

Ages: 21 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient is scheduled for bilateral LASIK surgery
• Patient is in good general health
• Eye glasses prescription of -1 to -8

Exclusion criteria

• Significant Dry Eye
• Presence of eye disease
• Uncontrolled systemic disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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137 participants in 2 patient groups

RESTASIS®

Active Comparator group

Description:

Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®)

Treatment:

Drug: Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®)

REFRESH ENDURA®

Active Comparator group

Description:

Artificial Tears (REFRESH ENDURA®)

Treatment:

Drug: Artificial Tears REFRESH ENDURA®