NCT00567983

Brief Summary

The purpose of this study is to evaluate the effect Restasis has in regards to disease progression.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Dec 2007

Shorter than P25 for phase_4

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

December 1, 2007

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

December 3, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 5, 2007

Completed
9 months 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 25, 2008

Status Verified

September 1, 2008

Enrollment Period

9 months

First QC Date

December 3, 2007

Last Update Submit

September 23, 2008

Conditions

Disease ProgressionDisease SeverityStainingSchirmersOSDI

Outcome Measures

Primary Outcomes (1)

  • Disease Severity

    1 yr

Secondary Outcomes (1)

  • Staining

    1 yr

Study Arms (2)

1.

ACTIVE COMPARATOR
Drug: Restasis

2.

PLACEBO COMPARATOR
Drug: Endura

Interventions

RestasisDRUG

Restasis- (in the eye) Instill one drop twice daily Endura- (in the eye) Instill one drop twice daily

1.
EnduraDRUG

Restasis- (in the eye) Instill one drop twice daily Endura- (in the eye) Instill one drop twice daily

2.

Eligibility Criteria

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

You may qualify if:

  • Mild to Moderate dry eye symptoms

You may not qualify if:

  • Current use of Restasis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lakeside Eye Clinic

Chicago, Illinois, 60641, United States

Location

MeSH Terms

Conditions

Disease Progression

Interventions

Cyclosporins

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Peptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Sanjay Rao

    Lakeside Eye Clinic

    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

December 3, 2007

First Posted

December 5, 2007

Study Start

December 1, 2007

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

September 25, 2008

Record last verified: 2008-09

Locations

US(1)