Clinical trial NCT06346340: A Study to Evaluate the Effect of Miebo™ on Preoperative Biometry/Keratometry and Postoperative Refractive Accuracy
Official title: A Phase 4, Multicenter, Open-Label Study to Evaluate the Effect of Miebo™ on Preoperative Biometry/ Keratometry and Postoperative Refractive Accuracy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dry Eye
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2024-04-04
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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):

   1. 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)
   2. Candidate for routine, uncomplicated cataract surgery (phacoemulsification with posterior chamber intraocular lens \[IOL\] implantation, not combined with any other surgery)
   3. In the Investigator's opinion, subject has potential postoperative pinhole Snellen visual acuity of at least 20/200 in both eyes
   4. Tear film break-up time ≤10 sec at Visit 1
   5. Total CFS score ≥2 and ≤11 (ie, sum of inferior, superior, central, nasal, and temporal), using the National Eye Institute scale at Visit 1
4. Ocular Surface Disease Index (OSDI) ≥23 at Visit 1
5. Able and willing to follow instructions, including participation in all trial assessments and visits.

Exclusion Criteria:

1. 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:

   1. History of eye trauma
   2. History of Stevens-Johnson syndrome
   3. Active blepharitis or lid margin inflammation
   4. DED secondary to scarring, irradiation, alkali burns, cicatricial pemphigoid, or destruction of conjunctival goblet cells (as with vitamin A deficiency)
   5. Abnormal lid anatomy causing incomplete eyelid closure
   6. Abnormal cornea shape (keratoconus)
   7. Corneal epithelial defect or significant confluent staining or filaments
   8. History of herpetic keratitis
   9. Ocular or periocular rosacea
2. Pterygium in either eye
3. 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
4. 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
5. 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
6. 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
7. Have active ocular allergies or ocular allergies that are expected to be active during the trial period
8. Have worn contact lenses within 1 month prior to Visit 1 or planned wear during the study
9. 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
10. Have active ocular or systemic infection (bacterial, viral, or fungal), including fever
11. Female subjects who are pregnant, nursing, or planning a pregnancy
12. 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.
13. Have an uncontrolled systemic disease that, in the opinion of the Investigator, will interfere with the trial
14. Have a known allergy and/or sensitivity to the investigational drug
15. 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
16. Have taken isotretinoin (eg, Accutane, Myorisan, Claravis, Amnesteem) within 6 months prior to Visit 1
17. 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.

Primary outcomes:
measure: Mean difference between absolute deviations from predicted refractive error in the study eye.
timeFrame: Assessed at Postop Day 30 ± 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Laguna Hills
country: United States
facility: Site 105
state: California
city: Petaluma
country: United States
facility: Site 102
state: California
city: Sacramento
country: United States
facility: Site 109
state: California
city: Grand Junction
country: United States
facility: Site 111
state: Colorado
city: Largo
country: United States
facility: Site 103
state: Florida
city: Oak Lawn
country: United States
facility: Site 106
state: Illinois
city: Alexandria
country: United States
facility: Site 108
state: Minnesota
city: Saint Louis
country: United States
facility: Site 104
state: Missouri
city: Somersworth
country: United States
facility: Site 101
state: New Hampshire
city: Sioux Falls
country: United States
facility: Site 107
state: South Dakota
city: San Antonio
country: United States
facility: Site 110
state: Texas
city: San Antonio
country: United States
facility: Site 112
state: Texas
Study officials:
References: