Study of Cyclosporine in Post-LASIK Patients

Allergan

Status and phase: Completed; Phase 2

Conditions: Laser In Situ Keratomileusis

Treatments: Drug: Placebo (Vehicle for Cyclosporine); Drug: Cyclosporine 0.005% eye drops; Drug: Cyclosporine 0.010% eye drops

Study type: Interventional

Funder types: Industry

Identifiers

NCT00991458

192371-018

Details and patient eligibility

About

This study will evaluate the safety and efficacy of Cyclosporine 0.005% and 0.010% eye drops administered twice daily before and following LASIK surgery.

Enrollment: 621 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
• Previous use of RESTASIS®

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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621 participants in 3 patient groups, including a placebo group

Cyclosporine 0.010% eye drops

Experimental group

Description:

Cyclosporine 0.010% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.

Treatment:

Drug: Cyclosporine 0.010% eye drops

Cyclosporine 0.005% eye drops

Experimental group

Description:

Cyclosporine 0.005% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.

Treatment:

Drug: Cyclosporine 0.005% eye drops

Placebo (Vehicle for Cyclosporine)

Placebo Comparator group

Description:

Placebo eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.

Treatment:

Drug: Placebo (Vehicle for Cyclosporine)