Dry Eye Disease (DED)
Conditions
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.
Interventions
DRUGSYSTANE® PRO
SYSTANE® PRO is a preservative free artificial tear with a unique triple action formula that contains hyaluronate, nano-sized lipids, and HP-Guar.
DRUGMIEBO™ (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.
Sponsors
Indiana University
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| OSDI Scores | Between group difference at 1 month | Between-group difference in mean change from baseline in Ocular Surface Disease Index (OSDI) Scores at the 1-month visit (0-100 scale). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Between-group difference in mean change from baseline in Eye Dryness Visual Analog (VAS) Scores at the 1-month visit | Between-group difference in mean change from baseline at 1 month | Between-group difference in mean change from baseline in Eye Dryness Visual Analog (VAS) Scores at the 1-month visit |
| Between-group difference in mean change from baseline in Ocular Surface Disease Index (OSDI) Scores at the 2 weeks visit | Between-group difference in mean change from baseline at 2 weeks | Between-group difference in mean change from baseline in Ocular Surface Disease Index (OSDI) Scores at the 2 weeks visit |
Countries
United States
Outcome results
None listed