SYSTANE® PRO vs. MIEBO™ for Dry Eye Syndrome

Not yet recruiting at 3 trial locations

Overseen By Anna Tichenor, OD, PhD, FAAO

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Indiana University

Must not be taking: Accutane, Ocular medications

Disqualifiers: Sjogren's syndrome, Ocular surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 4 weeks

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.

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. ^{1 2 3 4 5}

Why 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. ^{6 7 8 9 10}

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

Corrected visual acuity of 20/100 or better in both eyes

Ocular Surface Disease Index (OSDI) scores between 23 and 50 units

Tear break up time score of 5 seconds or less in both eyes

Exclusion Criteria

Pregnant or breastfeeding women

Conditions or situations that may put the subject at significant risk, confound study results, or interfere with study participation

Not allowed to use any other topical eye drops or dry eye treatments beyond their assignment during the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either SYSTANE® PRO or MIEBO™ for the treatment of dry eye disease

4 weeks

1 visit (in-person) at 1 month

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

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?

Group I: SYSTANE® PRO Active Control 1 Intervention

SYSTANE® PRO is a preservative free artificial tear with a unique triple action formula that contains hyaluronate, nano-sized lipids, and HP-Guar.

Group II: MIEBO™ (Perfluorohexyloctane, PFHO) Active Control 1 Intervention

Perfluorohexyloctane (PFHO) ophthalmic solution, which is marketed in the United States as MIEBO™ (Bausch + Lomb; Rochester, NY, USA) is a preservative-free eye drop.

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

Alcon Research

Industry Sponsor

Trials

739

Recruited

128,000+

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.pdf

Reported 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.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40696694/

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-miebor

Bausch + 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 ...

4. frontiersin.org frontiersin.org/journals/ophthalmology/articles/10.3389/fopht.2024.1452422/full

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.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06309953?term=NAME

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.

6. miebo-ecp.com miebo-ecp.com/

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.

7. miebo.com miebo.com/

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 ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11296276/

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.pdf

Perfluorohexyloctane (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 ...

10. miebo.com miebo.com/faqs/

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 ...