NCT00991458

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
621

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2009

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

October 7, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 8, 2009

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

July 11, 2013

Completed
Last Updated

July 11, 2013

Status Verified

July 1, 2013

Enrollment Period

1.5 years

First QC Date

October 7, 2009

Results QC Date

May 2, 2013

Last Update Submit

July 9, 2013

Conditions

Laser In Situ Keratomileusis

Outcome Measures

Primary Outcomes (1)

  • Time to Cure

    Time to cure is defined as the number of days after laser in situ keratomileusis (LASIK) surgery that the patient has corneal sensitivity (the capability of the cornea to respond to stimulation) ≥ 50 millimeters in all 9 regions of both eyes after LASIK surgery. A patient is considered cured at the first of 2 consecutive visits meeting these criteria. The Inter-Quartile Range presented is actually the 25th Quantile and the 75th Quantile obtained from the Kaplan-Meier Model.

    6 Months

Secondary Outcomes (3)

  • Time to Worst Outcome Post-LASIK Surgery in Tear Film Assessment

    Months 3 to 6

  • Percentage of Patients With Cumulative Poor Vision

    Month 3, Month 4, Month 5, Month 6

  • Worst Outcome Post-LASIK Surgery in Reading Speed Assessment

    Months 3 to 6

Study Arms (3)

Cyclosporine 0.010% eye drops

EXPERIMENTAL

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.

Drug: Cyclosporine 0.010% eye drops

Cyclosporine 0.005% eye drops

EXPERIMENTAL

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.

Drug: Cyclosporine 0.005% eye drops

Placebo (Vehicle for Cyclosporine)

PLACEBO COMPARATOR

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.

Drug: Placebo (Vehicle for Cyclosporine)

Interventions

Cyclosporine 0.010% eye dropsDRUG

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.

Cyclosporine 0.010% eye drops
Cyclosporine 0.005% eye dropsDRUG

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.

Cyclosporine 0.005% eye drops
Placebo (Vehicle for Cyclosporine)DRUG

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.

Placebo (Vehicle for Cyclosporine)

Eligibility Criteria

Age21 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Significant Dry Eye
  • Presence of eye disease
  • Uncontrolled systemic disease
  • Previous use of RESTASIS®

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Overland Park, Kansas, United States

Location

MeSH Terms

Interventions

CyclosporineOphthalmic Solutions

Intervention Hierarchy (Ancestors)

CyclosporinsPeptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and ProteinsPharmaceutical SolutionsSolutionsPharmaceutical PreparationsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesSpecialty Uses of Chemicals

Results Point of Contact

Title
Therapeutic Area Head,
Organization
Allergan, Inc
clinicaltrials@allergan.com
714-246-4500

Study Officials

  • Medical Director

    Allergan

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2009

First Posted

October 8, 2009

Study Start

October 1, 2009

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

July 11, 2013

Results First Posted

July 11, 2013

Record last verified: 2013-07

Locations

US(1)