SYSTANE® PRO vs. MIEBO™ in Dry Eye Disease

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

  • Dry Eye Disease (DED)

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