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Purpose

This is a prospective, randomized, double-masked, multi-site clinical trial designed to compare the efficacy of SYSTANE® PRO (Alcon Laboratories, Inc.) to MIEBO™ (Bausch + Lomb) in treating symptoms of evaporative dry eye disease (DED). The primary goal is to determine whether SYSTANE® PRO is non-inferior to MIEBO™ after one month of treatment, based on change in Ocular Surface Disease Index (OSDI) scores.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Adults>=18 years of age - Corrected visual acuity of 20/100 or better in both eyes - Ocular Surface Disease Index [OSDI] scores between 23 and 50 units [inclusive] - Tear break up time score of <=5 seconds in both eyes - Schirmer I test (without anesthesia) >=5 mm in both eyes

Exclusion Criteria

  • Discontinue contact lens wear starting 7 days prior and throughout the study - Artificial tears and warm compresses should not be used for at least one week prior to enrollment and throughout the study - Systemic health conditions that are known to alter tear film physiology(e.g., primary and secondary Sjogren's syndrome) - History of ocular surgery within the past 12 months - History of severe ocular trauma, active ocular infection or inflammation, have ever used Accutane or are currently using ocular medications. - Women who are pregnant or breast feeding(self report) - Subjects with a condition or in a situation, which in the investigator's opinion, may put the subject at significant rist, may confound the study results, or may significantly interfere with their participation in the study - Subjects will not be allowed to use any other topical eye drops or other dry eye treatments beyond their assignment during the study - Participants in clinical trial or study using a device, topical, or oral therapeutic in the past 3 months of enrollment

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
SYSTANE® PRO 		SYSTANE® PRO is a preservative free artificial tear with a unique triple action formula that contains hyaluronate, nano-sized lipids, and HP-Guar.
  • Drug: SYSTANE® PRO
    SYSTANE® PRO is a preservative free artificial tear with a unique triple action formula that contains hyaluronate, nano-sized lipids, and HP-Guar.
Active Comparator
MIEBO™ (Perfluorohexyloctane, PFHO) 		Perfluorohexyloctane (PFHO) ophthalmic solution, which is marketed in the United States as MIEBO™ (Bausch + Lomb; Rochester, NY, USA) is a preservative-free eye drop.
  • Drug: MIEBO™ (Perfluorohexyloctane, PFHO)
    Perfluorohexyloctane (PFHO) ophthalmic solution, which is marketed in the United States as MIEBO™ (Bausch + Lomb; Rochester, NY, USA) is a preservative-free eye drop.

Recruiting Locations

Eye Research Foundation
Newport Beach, California 92663
Contact:
David Wirta, MD
949-650-1863
david.wirta@drwirta.com

Indiana Universtiy School of Optometry
Bloomington, Indiana 47408

Kannarr Eye Care
Pittsburg, Kansas 66762
Contact:
Shane Kannarr, OD
620-235-1737
skannarr@kannarreyecare.com

Southern College of Optometry
Memphis, Tennessee 38104
Contact:
Chris Lievens, OD, MS, FNAP, FAAO
901-722-3250
clievens@sco.edu

More Details

Status
Recruiting
Sponsor
Indiana University

Study Contact

Anna Tichenor, OD, PhD, FAAO
812-855-0520
annatich@iu.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.