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

This study is currently recruiting participants.
Verified June 2012 by Innovative Medical
Sponsor:
Information provided by:
Innovative Medical
ClinicalTrials.gov Identifier:
NCT01382810
First received: June 24, 2011
Last updated: June 13, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Dry Eye Syndromes
Drug: Altaire Gel forming solution
Drug: Refresh Tears
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Randomized Masked Evaluation of Altaire Gel Forming Solution Versus Refresh Tears for the Treatment of Dry Eye Signs and Symptoms

Resource links provided by NLM:


Further study details as provided by Innovative Medical:

Primary Outcome Measures:
  • TBUT [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    Test performed that measures how long the tears take to break up

  • Conjunctival and Corneal staining [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    Dye that will be placed inside the eye to evaluate the surface of the ey


Estimated Enrollment: 100
Study Start Date: March 2011
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01382810

Contacts
Contact: Jenna Piel 951-653-5566 j.piel@imedsonline.com

Locations
United States, Illinois
Jackson Eye, SC Recruiting
Lake Villa, Illinois, United States
Contact: Annie Christensen    951-653-5566    a.christensen@imedsonline.com   
Principal Investigator: Mitch Jackson, MD         
United States, Rhode Island
Koch Eye Associates Recruiting
Warwick, Rhode Island, United States
Contact: Annie Christensen    951-653-5566    a.christensen@imedsonline.com   
Principal Investigator: Paul Koch, MD         
Sponsors and Collaborators
Innovative Medical
  More Information

No publications provided

Responsible Party: Melissa Earl, CRO
ClinicalTrials.gov Identifier: NCT01382810     History of Changes
Other Study ID Numbers: Altaire2011
Study First Received: June 24, 2011
Last Updated: June 13, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Innovative Medical:
dry eye signs and symptoms

Additional relevant MeSH terms:
Dry Eye Syndromes
Keratoconjunctivitis Sicca
Signs and Symptoms
Lacrimal Apparatus Diseases
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases

ClinicalTrials.gov processed this record on April 17, 2014