Comparing the Efficacy of Systane Pro to Miebo for the Treatment of Dry Eye Disease
Study on Investigational Treatments for Dry Eye Disease
ANNA TICHENOR
Primary Investigator
Brief description of study
The goal of this study is to determine if SYSTANE® PRO is non-inferior to PFHO with regards to treating DED symptoms. T
Detailed description of study
This project will be among the first to describe how SYSTANE® PRO compares to PFHO for the treatment of DED. Qualifying subjects will be randomized in a 1:1 manner to SYSTANE® PRO or PFHO four times a day. Subjects will be masked to the treatment via over labeling the commercially available bottles, and the investigators will be masked to the treatment (drops dispensed by study coordinator). Investigators will not be in the room during randomization or drop dispensing, and the unmasked study coordinator will educate the subject to not discuss their treatment in the presence of the investigators who are collecting subject data.
Subjects will be required to discontinue contact lens wear throughout the study. Artificial tears and warm compresses should not be used for at least one week prior to enrollment. Subjects will not be
allowed to use any eye drops beyond their assignment during the study.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Dry Eye Disease (DED)
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Age: 18 years - 100 years
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Gender: All
Inclusion criteria:
Adults ≥18 years of age who have corrected visual acuity of 20/100 or better and who have mild to moderate DED
Exclusion criteria:
- Subjects will be excluded if they have known systemic health conditions that are known to alter tear film physiology (e.g., primary and secondary Sjögren's
syndrome), - have a history of ocular surgery within the past 12 months,
- have a history of severe ocular trauma,
- active ocular infection or inflammation, have ever used Accutane or are currently using ocular medications,
- or if they are pregnant or breast feeding.
- Subjects with a condition or in a situation, which in the investigator’s opinion, may put the subject at significant risk, may confound the study results, or may significantly interfere
with their participation in the study will be excluded. - Subjects that have had a physical meibomian gland treatment within 3 months of enrollment (iLux, Lipiflow, IPL, Radiofrequency, etc.) will be excluded.
This study investigates the effectiveness of investigational treatments for dry eye disease (DED). The purpose of this study is to find out if one investigational treatment is as good as another in treating symptoms of DED, a condition where the eyes do not make enough tears or the tears evaporate too quickly, causing discomfort and vision problems.
Participants in this study will be randomly assigned to receive one of two investigational treatments four times a day. They will not know which treatment they are receiving, and neither will the researchers collecting data. Participants must stop using contact lenses and other eye drops during the study period.
- Who can participate: Adults 18 and older with mild to moderate dry eye disease and corrected vision of 20/100 or better may join. Exclusions include recent eye surgery, severe eye trauma, and certain health conditions.
- Study details: Participants will use an investigational treatment four times a day and must avoid other eye treatments during the study. An inactive substance that looks like the investigational treatment may be used to maintain study blinding.
