SYSTANE® PRO vs. MIEBO™ for Dry Eye Syndrome
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial compares two treatments, SYSTANE® PRO and MIEBO™, for evaporative dry eye disease (DED), which causes discomfort due to a lack of moisture on the eye surface. The main goal is to determine if SYSTANE® PRO is as effective as MIEBO™ in relieving symptoms after one month. The trial seeks participants who experience dry eye symptoms and have a certain level of vision clarity. Participants should not have had recent eye surgeries or severe eye injuries and must agree to pause other eye treatments during the trial. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, aiming to understand how it benefits more patients.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot use any other eye drops or dry eye treatments during the study.
What is the safety track record for these treatments?
Research shows that both SYSTANE® PRO and MIEBO™ have undergone safety testing in people with dry eye disease. SYSTANE® PRO, which contains no preservatives, is generally safe. Some individuals might experience mild side effects such as blurry vision or slight irritation, burning, or stinging in the eyes.
MIEBO™, a type of eye drop, is also safe and well-tolerated. Long-term studies indicate it remains effective in improving dry eye symptoms over time. The FDA has approved MIEBO™ for treating dry eye, supporting its safety.
Both treatments have undergone thorough testing, making them reliable options for managing dry eye symptoms.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about these treatments for dry eye syndrome because they offer unique features compared to standard options like traditional artificial tears and lubricating eye drops. SYSTANE® PRO is distinctive due to its triple action formula, which includes hyaluronate, nano-sized lipids, and HP-Guar, potentially providing enhanced lubrication and moisture retention without preservatives. MIEBO™, on the other hand, uses perfluorohexyloctane (PFHO) as its active ingredient, offering a preservative-free solution that could reduce eye irritation and improve comfort for users. Both treatments aim to address dry eye syndrome more effectively by targeting the condition with innovative ingredients and formulations.
What evidence suggests that this trial's treatments could be effective for dry eye syndrome?
This trial will compare SYSTANE® PRO and MIEBO™ for treating dry eye symptoms. Research has shown that both treatments are effective for this condition. Participants in the SYSTANE® PRO arm will receive a treatment that can significantly reduce the signs and discomfort of dry eyes, due to its unique blend of ingredients that help maintain eye moisture and comfort. Meanwhile, those in the MIEBO™ arm may experience rapid relief from dry eye symptoms, sometimes in just five minutes, as it has consistently proven effective in reducing eye dryness and discomfort. Overall, strong evidence supports the use of both treatments for relieving dry eye symptoms.678910
Are You a Good Fit for This Trial?
This trial is for individuals with evaporative dry eye disease. Participants should be diagnosed with this condition and willing to follow the treatment plan. Specific eligibility details are not provided, but typically participants must meet certain health criteria.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either SYSTANE® PRO or MIEBO™ for the treatment of dry eye disease
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- MIEBO™
- SYSTANE® PRO
Trial Overview
The study compares SYSTANE® PRO against MIEBO™ in treating dry eye symptoms over one month. It's a controlled test where patients don't know which treatment they're getting (double-masked), and it aims to see if SYSTANE® PRO is just as good as MIEBO™ based on OSDI scores.
How Is the Trial Designed?
2
Treatment groups
Active Control
SYSTANE® PRO is a preservative free artificial tear with a unique triple action formula that contains hyaluronate, nano-sized lipids, and HP-Guar.
Perfluorohexyloctane (PFHO) ophthalmic solution, which is marketed in the United States as MIEBO™ (Bausch + Lomb; Rochester, NY, USA) is a preservative-free eye drop.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Indiana University
Lead Sponsor
Alcon Research
Industry Sponsor
Raquel C. Bono
Alcon Research
Chief Medical Officer since 2022
MD from Harvard Medical School
David Endicott
Alcon Research
Chief Executive Officer since 2018
MBA from University of Southern California
Citations
1.
miebo-ecp.com
miebo-ecp.com/siteassets/pdf/opth-and-therapy-reprint-miebo-in-ded-early-symptom-study-results.pdfReported Outcomes in Dry Eye Disease
Conclusion: Early in the course of treatment with PFHO, patients with DED experienced significant reductions in dry eye symptom fre- quency and severity.
Efficacy and safety of perfluorohexyloctane (PFHO) in ...
It has proved to be highly effective in alleviating eye dryness and associated symptoms. While minor side effects are seen in a small subset of ...
3.
ir.bausch.com
ir.bausch.com/press-releases/bausch-lomb-announces-publication-phase-4-data-early-effects-mieborBausch + Lomb Announces Publication of Phase 4 Data ...
These patient-reported results show that MIEBO provided relief from dry eye symptoms quickly – in some cases in as little as five minutes after the patient's ...
Perfluorohexyloctane ophthalmic solution for dry eye disease
This study evaluated treatment effects of perfluorohexyloctane ophthalmic drop (formerly NOV03) in the pooled dataset from 2 pivotal clinical trials.
A Study to Evaluate Early Treatment Outcomes With Miebo ...
The primary objective of this study is to evaluate early outcomes with Miebo treatment in subjects with Dry Eye Disease (DED). Official Title.
MIEBO® (perfluorohexyloctane ophthalmic solution)
MIEBO ® (perfluorohexyloctane ophthalmic solution) is indicated for the treatment of the signs and symptoms of dry eye disease. IMPORTANT SAFETY INFORMATION.
MIEBO® (perfluorohexyloctane ophthalmic solution) Dry Eye ...
MIEBO ® (perfluorohexyloctane ophthalmic solution) is used to treat the signs and symptoms of dry eye disease. IMPORTANT SAFETY INFORMATION. Remove contact ...
Long-Term Safety and Efficacy of Perfluorohexyloctane ...
PFHO was safe and well tolerated and maintained efficacy for improving signs and symptoms of DED in this year-long study of patients with DED ...
9.
va.gov
va.gov/formularyadvisor/DOC_PDF/MON_Perfluorohexyloctane_MIEBO_Ophthalmic_Solution_Monograph.pdfPerfluorohexyloctane (MIEBO) Ophthalmic Solution
Key inclusions: ≥18 years of age, self-reported history of DED in both eyes for ≥ 6 months. • Tear film break-up time (TFBUT) ≤ 5 seconds (> 8-10 seconds is ...
MIEBO FAQs
Based on thorough testing in both laboratory and clinical studies, the FDA has approved MIEBO as a safe and effective treatment for the signs and symptoms of ...
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