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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
History of Changes
  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:

U.S. FDA Resources

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:
Lacrimal Apparatus Diseases
Dry Eye Syndromes
Keratoconjunctivitis Sicca
Signs and Symptoms
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
 Keratitis
Corneal Diseases
Carboxymethylcellulose Sodium
Laxatives
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013