A Study to Evaluate the Effect of Miebo™ on Preoperative Biometry/Keratometry and Postoperative Refractive Accuracy
- Registration Number
- NCT06346340
- Lead Sponsor
- Bausch & Lomb Incorporated
- Brief Summary
A Phase 4, Multicenter, Open-Label Study to Evaluate the Effect of Miebo™ on Preoperative Biometry/ Keratometry and Postoperative Refractive Accuracy
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 97
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At least 18 years of age at the time of consent
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Able to provide written voluntary informed consent
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The same eye must satisfy the below inclusion criteria (a-e):
- At least 1 eye with a visually significant cataract that has been scheduled for cataract surgery (eligible eye can be a subject's second eye to undergo cataract surgery as long as all eligibility criteria are met in that eye)
- Candidate for routine, uncomplicated cataract surgery (phacoemulsification with posterior chamber intraocular lens [IOL] implantation, not combined with any other surgery)
- In the Investigator's opinion, subject has potential postoperative pinhole Snellen visual acuity of at least 20/200 in both eyes
- Tear film break-up time ≤10 sec at Visit 1
- Total CFS score ≥2 and ≤11 (ie, sum of inferior, superior, central, nasal, and temporal), using the National Eye Institute scale at Visit 1
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Ocular Surface Disease Index (OSDI) ≥23 at Visit 1
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Able and willing to follow instructions, including participation in all trial assessments and visits.
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Have any clinically significant ocular surface slit-lamp findings in the study eye and/or, in the opinion of the Investigator, have any findings that could interfere with trial parameters, including:
- History of eye trauma
- History of Stevens-Johnson syndrome
- Active blepharitis or lid margin inflammation
- DED secondary to scarring, irradiation, alkali burns, cicatricial pemphigoid, or destruction of conjunctival goblet cells (as with vitamin A deficiency)
- Abnormal lid anatomy causing incomplete eyelid closure
- Abnormal cornea shape (keratoconus)
- Corneal epithelial defect or significant confluent staining or filaments
- History of herpetic keratitis
- Ocular or periocular rosacea
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Pterygium in either eye
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Use of any of the following ocular therapies in the study eye within 30 days prior to Visit 1: Vuity®, Qlosi™, topical ocular steroid treatments, prescription dry eye therapy including varenicline nasal spray, or topical anti-glaucoma medication
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Had a LipiFlow® procedure, intense pulse light procedure, or any kind of other procedure affecting meibomian glands in the study eye within 3 months prior to Visit 1
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Had received or removed a permanent punctum plug in the study eye within 1 month (3 months for dissolvable punctum plugs) prior to Visit 1
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Use of any eye drops (prescription or over-the-counter, such as artificial tears or Lumify®) and/orTrueTear™ device (intranasal tear neurostimulator) in the study eye within 24 hours prior to Visit 1
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Have active ocular allergies or ocular allergies that are expected to be active during the trial period
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Have worn contact lenses within 1 month prior to Visit 1 or planned wear during the study
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Have undergone intraocular surgery or ocular laser surgery in the study eye within 3 months prior to Visit 1; have undergone refractive surgery in the study eye within 2 years prior to Visit 1
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Have active ocular or systemic infection (bacterial, viral, or fungal), including fever
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Female subjects who are pregnant, nursing, or planning a pregnancy
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Female subjects of childbearing potential who are not using an acceptable means of birth control; acceptable methods of contraception include hormonal (oral, implantable, injectable, or transdermal) contraception; mechanical (spermicide in conjunction with a barrier such as a diaphragm or condom) contraception; intrauterine device; or surgical sterilization of partner. For non-sexually active female 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 to use adequate birth control as defined above for the remainder of the trial.
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Have an uncontrolled systemic disease that, in the opinion of the Investigator, will interfere with the trial
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Have a known allergy and/or sensitivity to the investigational drug
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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 is expected to be unstable during the trial
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Have taken isotretinoin (eg, Accutane, Myorisan, Claravis, Amnesteem) within 6 months prior to Visit 1
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Are currently enrolled in an investigational drug or device study or had used an investigational drug or device within 60 days prior to Visit 1.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Miebo treatment Miebo -
- Primary Outcome Measures
Name Time Method Mean difference between absolute deviations from predicted refractive error in the study eye. Assessed at Postop Day 30 ± 7 days Mean difference between absolute deviations from predicted refractive error in the study eye at Visit 3 (Second Eye/Unilateral Postop Day 30 ± 7 days).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (12)
Site 109
🇺🇸Sacramento, California, United States
Site 111
🇺🇸Grand Junction, Colorado, United States
Site 108
🇺🇸Alexandria, Minnesota, United States
Site 110
🇺🇸San Antonio, Texas, United States
Site 107
🇺🇸Sioux Falls, South Dakota, United States
Site 112
🇺🇸San Antonio, Texas, United States
Site 105
🇺🇸Laguna Hills, California, United States
Site 102
🇺🇸Petaluma, California, United States
Site 103
🇺🇸Largo, Florida, United States
Site 106
🇺🇸Oak Lawn, Illinois, United States
Site 104
🇺🇸Saint Louis, Missouri, United States
Site 101
🇺🇸Somersworth, New Hampshire, United States