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

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01382810
Enrollment
100
Registered
2011-06-27
Start date
2011-03-31
Completion date
2012-10-31
Last updated
2012-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Eye Syndromes

Keywords

dry eye signs and symptoms

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.

Interventions

DRUGAltaire Gel forming solution

Three times a day for two months

Three times a day for two months

Sponsors

Innovative Medical
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
TBUT2 monthsTest performed that measures how long the tears take to break up
Conjunctival and Corneal staining2 monthsDye that will be placed inside the eye to evaluate the surface of the ey

Countries

United States

Contacts

Primary ContactJenna Piel
j.piel@imedsonline.com951-653-5566

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026