No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
260 (estimated)
Sponsor
Indiana University · Other
Who this trial is looking for
This trial is looking for adults with evaporative dry eye disease to compare two eye treatments. Participants will receive either SYSTANE® PRO or MIEBO™ for one month and will complete surveys to check their symptoms.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 18 years old
I can see better than 20/100 in both eyes
My Ocular Surface Disease Index score is between 23 and 50
My tear break up time is 5 seconds or less in both eyes
My Schirmer I test score is 5 mm or more in both eyes
You may not be able to join if
I have worn contact lenses in the past week
I have used artificial tears or warm compresses in the past week
I have a health condition that affects tear production
I have had eye surgery in the last 12 months
I have a history of severe eye injury or infection
I am pregnant or breastfeeding
I am involved in another clinical trial or study
I am using any other eye drops or dry eye treatments
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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…
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 Locations
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Eligibility Criteria
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 bo…
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
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