A Study to Evaluate the Effect of Miebo™ on Preoperative Biometry/Keratometry and Postoperative Refractive Accuracy

Last updated: April 14, 2025
Sponsor: Bausch & Lomb Incorporated
Overall Status: Completed

Phase

4

Condition

N/A

Treatment

Miebo

Clinical Study ID

NCT06346340
936
  • Ages > 18
  • All Genders

Study Summary

A Phase 4, Multicenter, Open-Label Study to Evaluate the Effect of Miebo™ on Preoperative Biometry/ Keratometry and Postoperative Refractive Accuracy

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. At least 18 years of age at the time of consent

  2. Able to provide written voluntary informed consent

  3. The same eye must satisfy the below inclusion criteria (a-e):

  4. At least 1 eye with a visually significant cataract that has been scheduled forcataract surgery (eligible eye can be a subject's second eye to undergocataract surgery as long as all eligibility criteria are met in that eye)

  5. Candidate for routine, uncomplicated cataract surgery (phacoemulsification withposterior chamber intraocular lens [IOL] implantation, not combined with anyother surgery)

  6. In the Investigator's opinion, subject has potential postoperative pinholeSnellen visual acuity of at least 20/200 in both eyes

  7. Tear film break-up time ≤10 sec at Visit 1

  8. Total CFS score ≥2 and ≤11 (ie, sum of inferior, superior, central, nasal, andtemporal), using the National Eye Institute scale at Visit 1

  9. Ocular Surface Disease Index (OSDI) ≥23 at Visit 1

  10. Able and willing to follow instructions, including participation in all trialassessments and visits.

Exclusion

Exclusion Criteria:

  1. Have any clinically significant ocular surface slit-lamp findings in the study eyeand/or, in the opinion of the Investigator, have any findings that could interferewith trial parameters, including:

  2. History of eye trauma

  3. History of Stevens-Johnson syndrome

  4. Active blepharitis or lid margin inflammation

  5. DED secondary to scarring, irradiation, alkali burns, cicatricial pemphigoid,or destruction of conjunctival goblet cells (as with vitamin A deficiency)

  6. Abnormal lid anatomy causing incomplete eyelid closure

  7. Abnormal cornea shape (keratoconus)

  8. Corneal epithelial defect or significant confluent staining or filaments

  9. History of herpetic keratitis

  10. Ocular or periocular rosacea

  11. Pterygium in either eye

  12. Use of any of the following ocular therapies in the study eye within 30 days priorto Visit 1: Vuity®, Qlosi™, topical ocular steroid treatments, prescription dry eyetherapy including varenicline nasal spray, or topical anti-glaucoma medication

  13. Had a LipiFlow® procedure, intense pulse light procedure, or any kind of otherprocedure affecting meibomian glands in the study eye within 3 months prior to Visit 1

  14. Had received or removed a permanent punctum plug in the study eye within 1 month (3months for dissolvable punctum plugs) prior to Visit 1

  15. Use of any eye drops (prescription or over-the-counter, such as artificial tears orLumify®) and/orTrueTear™ device (intranasal tear neurostimulator) in the study eyewithin 24 hours prior to Visit 1

  16. Have active ocular allergies or ocular allergies that are expected to be activeduring the trial period

  17. Have worn contact lenses within 1 month prior to Visit 1 or planned wear during thestudy

  18. Have undergone intraocular surgery or ocular laser surgery in the study eye within 3months prior to Visit 1; have undergone refractive surgery in the study eye within 2years prior to Visit 1

  19. Have active ocular or systemic infection (bacterial, viral, or fungal), includingfever

  20. Female subjects who are pregnant, nursing, or planning a pregnancy

  21. Female subjects of childbearing potential who are not using an acceptable means ofbirth control; acceptable methods of contraception include hormonal (oral,implantable, injectable, or transdermal) contraception; mechanical (spermicide inconjunction with a barrier such as a diaphragm or condom) contraception;intrauterine device; or surgical sterilization of partner. For non-sexually activefemale subjects, abstinence may be regarded as an adequate method of birth control;however, if the subject becomes sexually active during the trial, she must agree touse adequate birth control as defined above for the remainder of the trial.

  22. Have an uncontrolled systemic disease that, in the opinion of the Investigator, willinterfere with the trial

  23. Have a known allergy and/or sensitivity to the investigational drug

  24. Use of any oral medications known to cause ocular drying (eg, antihistamines,antidepressants, etc.) on a non-stable regimen within 1 month prior to Visit 1 or isexpected to be unstable during the trial

  25. Have taken isotretinoin (eg, Accutane, Myorisan, Claravis, Amnesteem) within 6months prior to Visit 1

  26. Are currently enrolled in an investigational drug or device study or had used aninvestigational drug or device within 60 days prior to Visit 1.

Study Design

Total Participants: 97
Treatment Group(s): 1
Primary Treatment: Miebo
Phase: 4
Study Start date:
April 30, 2024
Estimated Completion Date:
February 24, 2025

Study Description

The primary objective is to determine the effect of preoperative Miebo treatment on the accuracy of preoperative biometry/keratometry and predicted refraction in subjects with dry eye disease (DED) who are already scheduled for cataract surgery.

Connect with a study center

  • Site 105

    Laguna Hills, California 92655
    United States

    Site Not Available

  • Site 102

    Petaluma, California 92954
    United States

    Site Not Available

  • Site 109

    Sacramento, California 94206
    United States

    Site Not Available

  • Site 111

    Grand Junction, Colorado 81501
    United States

    Site Not Available

  • Site 103

    Largo, Florida 33770
    United States

    Site Not Available

  • Site 106

    Oak Lawn, Illinois 60453
    United States

    Site Not Available

  • Site 108

    Alexandria, Minnesota 56308
    United States

    Site Not Available

  • Site 104

    Saint Louis, Missouri 63131
    United States

    Site Not Available

  • Site 101

    Somersworth, New Hampshire 03878
    United States

    Site Not Available

  • Site 107

    Sioux Falls, South Dakota 57108
    United States

    Site Not Available

  • Site 110

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Site 112

    San Antonio, Texas 78229
    United States

    Site Not Available

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