Back to resultsAltaire Gel Forming Solution Versus Refresh Tears for the Treatment of Dry Eye Signs and Symptoms
Primary Purpose
Dry Eye Syndromes
Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Altaire Gel forming solution
Refresh Tears
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye Syndromes focused on measuring dry eye signs and symptoms
Eligibility 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.
Sites / Locations
- Jackson Eye, SCRecruiting
- Koch Eye AssociatesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Altaire Gel forming solution
Refresh Tears
Arm Description
Outcomes
Primary Outcome Measures
TBUT
Test performed that measures how long the tears take to break up
Conjunctival and Corneal staining
Dye that will be placed inside the eye to evaluate the surface of the ey
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01382810
Brief Title
Altaire Gel Forming Solution Versus Refresh Tears for the Treatment of Dry Eye Signs and Symptoms
Official Title
A Randomized Masked Evaluation of Altaire Gel Forming Solution Versus Refresh Tears for the Treatment of Dry Eye Signs and Symptoms
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Unknown status
Study Start Date
March 2011 (undefined)
Primary Completion Date
October 2012 (Anticipated)
Study Completion Date
October 2012 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Innovative Medical
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndromes
Keywords
dry eye signs and symptoms
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Altaire Gel forming solution
Arm Type
Active Comparator
Arm Title
Refresh Tears
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Altaire Gel forming solution
Intervention Description
Three times a day for two months
Intervention Type
Drug
Intervention Name(s)
Refresh Tears
Intervention Description
Three times a day for two months
Primary Outcome Measure Information:
Title
TBUT
Description
Test performed that measures how long the tears take to break up
Time Frame
2 months
Title
Conjunctival and Corneal staining
Description
Dye that will be placed inside the eye to evaluate the surface of the ey
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jenna Piel
Phone
951-653-5566
Email
j.piel@imedsonline.com
Facility Information:
Facility Name
Jackson Eye, SC
City
Lake Villa
State/Province
Illinois
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Annie Christensen
Phone
951-653-5566
Email
a.christensen@imedsonline.com
First Name & Middle Initial & Last Name & Degree
Mitch Jackson, MD
Facility Name
Koch Eye Associates
City
Warwick
State/Province
Rhode Island
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Annie Christensen
Phone
951-653-5566
Email
a.christensen@imedsonline.com
First Name & Middle Initial & Last Name & Degree
Paul Koch, MD
12. IPD Sharing Statement
Learn more about this trial
Altaire Gel Forming Solution Versus Refresh Tears for the Treatment of Dry Eye Signs and Symptoms
We'll reach out to this number within 24 hrs