search
Back to results

Efficacy and Safety of a New Multi-dose Lubricant Eye Drop Concomitant With Restasis® (Cyclosporine A) for the Treatment of Dry Eye Symptoms

Primary Purpose

Dry Eye

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Restasis, Optive Tears
Sponsored by
Innovative Medical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • · 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

Exclusion Criteria:

  • · 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

Sites / Locations

  • Minnesota Eye Consultants

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

A

Arm Description

Outcomes

Primary Outcome Measures

efficacy

Secondary Outcome Measures

dry eye symptoms

Full Information

First Posted
November 28, 2006
Last Updated
February 19, 2010
Sponsor
Innovative Medical
search

1. Study Identification

Unique Protocol Identification Number
NCT00405457
Brief Title
Efficacy and Safety of a New Multi-dose Lubricant Eye Drop Concomitant With Restasis® (Cyclosporine A) for the Treatment of Dry Eye Symptoms
Official Title
Efficacy and Safety of a New Multi-dose Lubricant Eye Drop Concomitant With Restasis® (Cyclosporine A) for the Treatment of Dry Eye Symptoms
Study Type
Interventional

2. Study Status

Record Verification Date
February 2010
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
January 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Innovative Medical

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Restasis, Optive Tears
Intervention Description
Restasis and Optive Tears use twice daily more frequently if needed
Primary Outcome Measure Information:
Title
efficacy
Time Frame
1 yr 3 months
Secondary Outcome Measure Information:
Title
dry eye symptoms
Time Frame
1 yr 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: · 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 Exclusion Criteria: · 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Hardten, MD
Organizational Affiliation
Minnesota Eye Consultants
Official's Role
Principal Investigator
Facility Information:
Facility Name
Minnesota Eye Consultants
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Efficacy and Safety of a New Multi-dose Lubricant Eye Drop Concomitant With Restasis® (Cyclosporine A) for the Treatment of Dry Eye Symptoms

We'll reach out to this number within 24 hrs