Altaire Gel Forming Solution Versus Refresh Tears for the Treatment of Dry Eye Signs and Symptoms

June 13, 2012 updated by: Innovative Medical

A Randomized Masked Evaluation of Altaire Gel Forming Solution Versus Refresh Tears for the Treatment of Dry Eye Signs and Symptoms

The purpose of this study is to evaluate and compare the effects of Altaire Gel forming solution and Refresh Tears in mild-moderate dry eye patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Lake Villa, Illinois, United States
        • Recruiting
        • Jackson Eye, SC
    • Rhode Island
      • Warwick, Rhode Island, United States
        • Recruiting
        • Koch Eye Associates
        • Principal Investigator:
          • Paul Koch, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients 18 years or older.
  • Males or females.
  • Patient reported dry eye symptoms (episodic, annoying, activity limiting).
  • Physician assessment of mild-moderate dry eye.
  • Patient willing to instill drops TID and complete entire length of protocol.
  • TBUT _< 10 seconds.
  • At least Grade 6 Corneal Staining.

Exclusion Criteria:

  • Current topical cyclosporine use (Restasis)
  • Current Refresh use.
  • Refractive surgery within the last 6 months.
  • Oral or topical corticosteroid use.
  • Severe dry eye patients by physician assessment.
  • Current active blepharitis.
  • Oral doxycycline use.
  • Oral antihistamine use.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Altaire Gel forming solution
Drug: Altaire Gel forming solution
Three times a day for two months
Placebo Comparator: Refresh Tears
Drug: Refresh Tears
Three times a day for two months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
TBUT
Time Frame: 2 months
Test performed that measures how long the tears take to break up
2 months
Conjunctival and Corneal staining
Time Frame: 2 months
Dye that will be placed inside the eye to evaluate the surface of the ey
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Innovative Medical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Anticipated)

October 1, 2012

Study Completion (Anticipated)

October 1, 2012

Study Registration Dates

First Submitted

June 24, 2011

First Submitted That Met QC Criteria

June 24, 2011

First Posted (Estimate)

June 27, 2011

Study Record Updates

Last Update Posted (Estimate)

June 14, 2012

Last Update Submitted That Met QC Criteria

June 13, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Altaire2011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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