SYSTANE® PRO vs. MIEBO™ in Dry Eye Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

260 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-15

Study Completion Date

2026-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Dry Eye Disease (DED)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

SYSTANE® PRO

Intervention Type DRUG

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

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.

Group Type ACTIVE_COMPARATOR

MIEBO™ (Perfluorohexyloctane, PFHO)

Intervention Type DRUG

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

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No