NCT00335114

Brief Summary

Cyclosporine Ophthalmic Emulsion is currently used in the treatment of dry eye syndrome. Contact lens wearers frequently suffer from dry eye syndrome. The purpose of this study is to evaluate cyclosporine ophthalmic emulsion verses re-wetting drops in the relief of dry eye symptoms in contact lens wearers

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2005

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

November 1, 2005

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 7, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 8, 2006

Completed
Last Updated

May 9, 2023

Status Verified

May 1, 2023

First QC Date

June 7, 2006

Last Update Submit

May 5, 2023

Conditions

Contact Lens Wearers With Dry Eye Syndrome

Keywords

cyclosporine, dry eye syndrome, contact lens

Outcome Measures

Primary Outcomes (2)

  • Ocular exams and questionnaires at baseline and at 3 months will determine

  • the effect of cyclosporine on dry eye syndrome.

Secondary Outcomes (2)

  • Increased contact lens wearing time due to a decrease in severity

  • of dry eye symptoms

Interventions

cyclosporine ophthalmic emulsionDRUG

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • contact lens wearer
  • clinical diagnosis of dry eye syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UAB Ophthalmology Services Foundation

Birmingham, Alabama, 35233, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Cyclosporins

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Peptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Carol E Rosenstiel, OD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Director of Contact Lens Service

Study Record Dates

First Submitted

June 7, 2006

First Posted

June 8, 2006

Study Start

November 1, 2005

Study Completion

April 1, 2006

Last Updated

May 9, 2023

Record last verified: 2023-05

Locations

US(1)