A Study to Evaluate Corneal Endothelial Cell Density (ECD) in Subjects With Dry Eye Disease (DED) Administering Miebo® (Perfluorohexyloctane Ophthalmic Solution) for 12 Months.

December 16, 2024 updated by: Bausch & Lomb Incorporated

A Randomized, Multicenter, Double-Masked, Saline-Controlled Trial to Evaluate Corneal Endothelial Cell Density in Subjects With Dry Eye Disease Administering Miebo® (Perfluorohexyloctane Ophthalmic Solution) for 12 Months.

A Randomized, Multicenter, Double-Masked, Saline-Controlled Trial to Evaluate Corneal Endothelial Cell Density in Subjects With Dry Eye Disease Administering Miebo® (Perfluorohexyloctane Ophthalmic Solution) for 12 Months

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

216

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Glendale, California, United States, 91204
        • Site 101
      • Murrieta, California, United States, 92562
        • Site 112
      • Newport Beach, California, United States, 92663
        • Site 102
      • Rancho Cordova, California, United States, 95670
        • Site 109
      • Torrance, California, United States, 90505
        • Site 106
    • Florida
      • Delray Beach, Florida, United States, 33484
        • Site 113
    • Georgia
      • Morrow, Georgia, United States, 30260
        • Site 107
    • Indiana
      • Carmel, Indiana, United States, 46290
        • Site 105
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Site 110
      • Saint Louis, Missouri, United States, 63131
        • Site 104
    • North Carolina
      • Asheville, North Carolina, United States, 28803
        • Site 108
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Site 103

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Be at least 18 years of age at the time of consent.
  2. Have a self-reported history of DED in both eyes (OU) for at least 6 months prior to Visit 1 (Screening/Baseline)
  3. Have a total corneal fluorescein staining score (tCFS) score >2 in both eyes
  4. Have an Ocular Surface Disease Index (OSDI) score >17
  5. Have a baseline ECD ≥1750 cells/mm2 in each eye
  6. Provide written informed consent
  7. Be able and willing to follow instructions, including participation in all trial assessments and visits
  8. If a contact lens wearer, be willing to discontinue contact lens use during and for 30 minutes following instillation of investigational drug and during study visits

Exclusion Criteria:

  1. Be at least 18 years of age at the time of consent.
  2. Have a self-reported history of DED in both eyes (OU) for at least 6 months prior to Visit 1 (Screening/Baseline)
  3. Have a total corneal fluorescein staining score (tCFS) score >2 in both eyes
  4. Have an Ocular Surface Disease Index (OSDI) score >17
  5. Have a baseline ECD ≥1750 cells/mm2 in each eye
  6. Provide written informed consent
  7. Be able and willing to follow instructions, including participation in all trial assessments and visits
  8. If a contact lens wearer, be willing to discontinue contact lens use during and for 30 minutes following instillation of investigational drug and during study visits
  9. Have any clinically significant ocular surface slit lamp findings and/or in the opinion of the Investigator have any findings that may interfere with trial parameters in either eye
  10. Have an ocular or periocular malignancy in either eye
  11. Have a history of herpetic keratitis in either eye
  12. Have any planned ocular and/or lid surgeries in either eye during the course of the study
  13. Have a known allergy and/or sensitivity to the IP
  14. Have a history of ocular laser surgery in either eye within 3 months (90 days) prior to Visit 1 (Screening/Baseline)
  15. Have a history of incisional ocular surgery or severe trauma in either eye within 3 months (90 days) prior to Visit 1 (Screening/Baseline)
  16. Have high contrast best-corrected visual acuity equal to or worse than logMAR +0.7 (Snellen equivalent score of 20/100 or worse) as assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) scale in either eye, obtained under bright room lighting
  17. Be a woman who is pregnant, nursing or planning a pregnancy during the course of the study
  18. Be a woman of childbearing potential who is unwilling to submit to a urine pregnancy test. Non-childbearing potential is defined as a woman who is permanently sterilized (eg, has had a hysterectomy or bilateral tubal ligation or bilateral oophorectomy) or is postmenopausal (without menses for 12 consecutive months).
  19. Be a woman of childbearing potential who is not using an acceptable method of birth control. Acceptable methods of contraception include hormonal - oral, implantable, injectable, or transdermal - contraceptives; mechanical contraception - spermicide in conjunction with a barrier such as a diaphragm or condom; intrauterine device; or surgical sterilization of partner. For non-sexually active females, abstinence may be regarded as an adequate method of birth control; however, the subject must agree to use adequate birth control as defined above for the remainder of the study if she becomes sexually active during the trial.
  20. Be currently enrolled in an investigational drug or device trial or plan to enroll during the course of the study
  21. Have a condition or be in a situation that the Investigator believes may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Miebo
100% perfluorohexyloctane 4 times daily (QID)
Drug: Miebo
100% perfluorohexyloctane
Placebo Comparator: Saline solution
(0.6% sodium chloride solution) 4 times daily (QID)
Drug: Saline
0.6% sodium chloride solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean change from baseline in ECD
Time Frame: Assessed at Month 3 and Month 12 Visits
Mean change from baseline in ECD in the study eye at the Month 3 and Month 12 Visits
Assessed at Month 3 and Month 12 Visits

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bausch & Lomb Incorporated

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 31, 2024

Primary Completion (Estimated)

November 1, 2025

Study Completion (Estimated)

November 1, 2025

Study Registration Dates

First Submitted

August 20, 2024

First Submitted That Met QC Criteria

August 21, 2024

First Posted (Actual)

August 22, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 16, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 933

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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