NCT00349440

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
93

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2006

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 5, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 7, 2006

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2006

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

September 26, 2008

Status Verified

September 1, 2008

Enrollment Period

2 years

First QC Date

July 5, 2006

Last Update Submit

September 23, 2008

Conditions

Dry Eye Syndromes

Keywords

Dry eye

Outcome Measures

Primary Outcomes (1)

  • Dry Eye Symptoms

    1.5 years

Secondary Outcomes (1)

  • Dry eye signs

    1.5 yrs

Study Arms (2)

1

ACTIVE COMPARATOR
Drug: Cyclosporine, Refresh Plus

2

PLACEBO COMPARATOR
Drug: Cyclosporine, Refresh Plus

Interventions

Cyclosporine, Refresh PlusDRUG

Cyclosporine 0.4ml (in the eye) on for 3 months instill one drop in randomized eye twice daily. Refresh Plus 0.4ml (in the eye) on for 3 months instill one drop in randomized eye twice daily.

12

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Southeastern Laser and Refractive Surgery

Greensboro, North Carolina, 27410, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Cyclosporine

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

CyclosporinsPeptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Karl Stonecipher, MD

    Southeastern Laser and Refractive Surgery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 5, 2006

First Posted

July 7, 2006

Study Start

September 1, 2006

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

September 26, 2008

Record last verified: 2008-09

Locations

US(1)