NCT07243275

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
260

participants targeted

Target at P75+ for phase_4

Timeline
4mo left

Started Feb 2026

Shorter than P25 for phase_4

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress35%
Feb 2026Sep 2026

First Submitted

Initial submission to the registry

November 17, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 21, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

February 18, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

7 months

First QC Date

November 17, 2025

Last Update Submit

March 26, 2026

Conditions

Dry Eye Disease (DED)

Outcome Measures

Primary Outcomes (1)

  • OSDI Scores

    Between-group difference in mean change from baseline in Ocular Surface Disease Index (OSDI) Scores at the 1-month visit (0-100 scale).

    Between group difference at 1 month

Study Arms (2)

SYSTANE® PRO

ACTIVE COMPARATOR

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

MIEBO™ (Perfluorohexyloctane, PFHO)

ACTIVE COMPARATOR

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)

Interventions

SYSTANE® PRODRUG

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

SYSTANE® PRO
MIEBO™ (Perfluorohexyloctane, PFHO)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.

MIEBO™ (Perfluorohexyloctane, PFHO)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Eye Research Foundation

Newport Beach, California, 92663, United States

RECRUITING

Indiana Universtiy School of Optometry

Bloomington, Indiana, 47408, United States

RECRUITING

Kannarr Eye Care

Pittsburg, Kansas, 66762, United States

RECRUITING

Southern College of Optometry

Memphis, Tennessee, 38104, United States

RECRUITING

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

perfluorohexyl-octan

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Central Study Contacts

Anna Tichenor, OD, PhD, FAAO

CONTACT

812-855-0520annatich@iu.edu

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 17, 2025

First Posted

November 21, 2025

Study Start

February 18, 2026

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

September 30, 2026

Last Updated

March 27, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(4)