NCT00405457

Brief Summary

To evaluate the efficacy, safety and tolerability of a combination of Optive® Artificial Tears with Restasis®.The primary hypothesis is that the Ocular Surface Disease Index (OSDI) score and symptoms will be the same or lower than baseline after treatment in these patients. The patients will tolerate the combination of Restasis® and Optive® with a low incidence of clinical adverse events.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Nov 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

November 28, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 30, 2006

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
Last Updated

February 22, 2010

Status Verified

February 1, 2010

Enrollment Period

1.2 years

First QC Date

November 28, 2006

Last Update Submit

February 19, 2010

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (1)

  • efficacy

    1 yr 3 months

Secondary Outcomes (1)

  • dry eye symptoms

    1 yr 3 months

Study Arms (1)

A

OTHER
Drug: Restasis, Optive Tears

Interventions

Restasis, Optive TearsDRUG

Restasis and Optive Tears use twice daily more frequently if needed

A

Eligibility Criteria

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

You may qualify if:

  • · Males or females \> 18 years old
  • Patients currently taking Restasis® for at least 3 months in duration and using artificial tears as needed for dry eye.
  • Likely to complete all study visits and able to provide informed consent

You may not qualify if:

  • · Patients using Restasis® for less than 3 months.
  • 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.
  • Other active uncontrolled ocular diseases or uncontrolled systemic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Minnesota Eye Consultants

Minneapolis, Minnesota, 55404, 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

  • David Hardten, MD

    Minnesota Eye Consultants

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 28, 2006

First Posted

November 30, 2006

Study Start

November 1, 2006

Primary Completion

January 1, 2008

Study Completion

January 1, 2008

Last Updated

February 22, 2010

Record last verified: 2010-02

Locations

US(1)