Recruiting

Altaire Gel & Refresh Tears

Sponsor:

Innovative Medical

Code:

NCT01382810

Conditions

Dry Eye Syndromes

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Altaire Gel forming solution

Refresh Tears

Study Details

Brief summary:

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.

Conditions

Dry Eye Syndromes

Study ID

NCT01382810

Start date

Mar, 2011

Status verified date

Jun, 2012

Completion date

Oct, 2012

Anticipated

Primary completion date

Oct, 2012

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Altaire Gel forming solution

placebo comparator: Refresh Tears

Interventions

Altaire Gel forming solution

Three times a day for two months

Refresh Tears

Three times a day for two months

Primary outcome measure

  • TBUT [ Time Frame: 2 months ]
  • Conjunctival and Corneal staining [ Time Frame: 2 months ]

Central Contacts and Locations

Central contacts

Jenna Piel

951-653-5566j.piel@imedsonline.com

Locations

Jackson Eye, SC

Recruiting

Lake Villa, Illinois, United States

Contacts

Annie Christensen

951-653-5566a.christensen@imedsonline.com

Principal Investigator:

Mitch Jackson, MD

Koch Eye Associates

Recruiting

Warwick, Rhode Island, United States

Contacts

Annie Christensen

951-653-5566a.christensen@imedsonline.com

Principal Investigator:

Paul Koch, MD

More Information

Sponsor

Innovative Medical

Last update posted

Jun 14, 2012

Last verified

Jun, 2012

Keywords

  • dry eye signs and symptoms

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Innovative Medical on 2012-06-14.