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

Dry Eye Syndromes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01382810
• Other study ID #: Altaire2011
• Status: Recruiting
• Phase: Phase 4
• First received: June 24, 2011
• Last updated: June 13, 2012
• Start date: March 2011
• Est. completion date: October 2012

Study information

• Verified date: June 2012
• Source: Innovative Medical
• Contact: Jenna Piel
• Phone: 951-653-5566
• Email: j.piel[@]imedsonline.com
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Keratoconjunctivitis Sicca
• Signs and Symptoms

Intervention

Drug:
• Altaire Gel forming solution
Three times a day for two months
• Refresh Tears
Three times a day for two months

Locations

Country	Name	City	State
United States	Jackson Eye, SC	Lake Villa	Illinois
United States	Koch Eye Associates	Warwick	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Innovative Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TBUT	Test performed that measures how long the tears take to break up	2 months	No
Primary	Conjunctival and Corneal staining	Dye that will be placed inside the eye to evaluate the surface of the ey	2 months	No