Overview
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.
Eligibility
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
