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Azusa, California 91702


Evaluate the investigational formulation (IE) in patients with signs and symptoms of Dry Eye Disease

Study summary:

The purpose of the present study is to evaluate the clinical tolerability and acceptability of IE in comparison with two established marketed eye drops of similar viscocity, Systane® Gel Drops and Genteal® Lubricant Gel Drops.


Inclusion Criteria: - Visit 1 (Screening) Ocular Surface Disease Index© (OSDI©) score of ≥ 23 and ≤ 65 - Visit 2 (Baseline1/randomization) OSDI© score of ≥ 18 and ≤ 65 - Three consecutive tear break-up time (TBUT) tests ≤ 10 seconds in at least one eye at Visit 1 (Screening) and Visit 2 (Baseline1/randomization) - Current use of an artificial tear at least twice daily on average, for at least one month prior to Visit 1 (Screening). The name of the currently used artificial tear and average daily frequency of use over the past month prior to screening will be recorded by the investigator - • Distance visual acuity of at least 20/40 or better in each eye with existing correction (if necessary) at Visit 1(Screening) and Visit 2 (Baseline1/randomization) Exclusion Criteria: - History of prior ocular/ophthalmic surgery or trauma which could affect corneal sensitivity and/or tear distribution (eg, cataract surgery, laser-assisted in situ keratomileusis (LASIK), photorefractive keratectomy or any surgery involving a limbal or corneal incision) within 6 months prior to Visit 1 (Screening) - Patient anticipates contact lens wear during the study, or the patient has worn contact lenses within 3 months of Visit 1 (Screening) - Currently using or have used, within 3 months of Visit 1 (Screening), RESTASIS® Cyclosporine Ophthalmic Emulsion or any topical cyclosporine - Current or past diagnosis of glaucoma or are currently using a topical glaucoma medication - Glaucoma suspect as determined by the investigator (investigator may consider multiple factors including but not limited to intraocular pressure (IOP), visual field results, family history, optical coherence tomography (OCT), optic nerve cup to disc ratio, angle anatomy, pachymetry, and biomicroscopy in making this determination) - Significant cataract which, in the investigator's opinion, may interfere with the interpretation of the study results



Primary Contact:

Principal Investigator
Milton M Hom, OD FAAO

Backup Contact:


Location Contact:

Azusa, California 91702
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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