SYSTANE® PRO vs. MIEBO™ in Dry Eye Disease

Indiana University

Status and phase: Not yet enrolling; Phase 4

Conditions: Dry Eye Disease (DED)

Treatments: Drug: MIEBO™ (Perfluorohexyloctane, PFHO); Drug: SYSTANE® PRO

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07243275

28245

Details and patient eligibility

About

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.

Enrollment: 260 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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260 participants in 2 patient groups

SYSTANE® PRO

Active Comparator group

Description:

SYSTANE® PRO is a preservative free artificial tear with a unique triple action formula that contains hyaluronate, nano-sized lipids, and HP-Guar.

Treatment:

Drug: SYSTANE® PRO

MIEBO™ (Perfluorohexyloctane, PFHO)

Active Comparator group

Description:

Perfluorohexyloctane (PFHO) ophthalmic solution, which is marketed in the United States as MIEBO™ (Bausch + Lomb; Rochester, NY, USA) is a preservative-free eye drop.

Treatment:

Drug: MIEBO™ (Perfluorohexyloctane, PFHO)