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New treatment option for Dry Eye Disease (DED)
Official title SYSTANE® PRO vs. MIEBO™ in Dry Eye Disease
ClinicalTrials.gov ID: NCT07243275
What this study is testing
What is SYSTANE® PRO?
SYSTANE® PRO is an investigational medicine, being studied as a potential treatment for dry eye disease (ded).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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 likely can't join 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)
See the full eligibility 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
- 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)
- people 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...
- people 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
The study team makes the final eligibility decision.
Where it's taking place
- Newport Beach, California, United States
- Bloomington, Indiana, United States
- Pittsburg, Kansas, United States
- Memphis, Tennessee, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Newport Beach, California, United States; Bloomington, Indiana, United States; Pittsburg, Kansas, United States; Memphis, Tennessee, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.