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

NCT06346340 | Completed Phase 4 FDA Drug

• 1 other identifier: 936
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 12

Brief Summary

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

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (1)

• Mean difference between absolute deviations from predicted refractive error in the study eye.

  Mean difference between absolute deviations from predicted refractive error in the study eye at Visit 3 (Second Eye/Unilateral Postop Day 30 ± 7 days).

  Assessed at Postop Day 30 ± 7 days

Study Arms (1)

Miebo treatment

EXPERIMENTAL

Drug: Miebo

Interventions

Miebo DRUG

Miebo applied in both eyes 4 times per day for approximately 30 days before cataract surgery. Following the completion of the standard follow up, approximately 30 days after cataract surgery, subjects will begin a second regimen of Miebo , 4 times per day in both eyes, for approximately 30 days.

Miebo treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years of age at the time of consent
• Able to provide written voluntary informed consent
• 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
• Ocular Surface Disease Index (OSDI) ≥23 at Visit 1
• Able and willing to follow instructions, including participation in all trial assessments and visits.

You may not qualify if:

• 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
• Pterygium in either eye
• 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
• 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
• 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
• 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

Sponsors & Collaborators

• Bausch & Lomb Incorporated: lead

Study Sites (12)

Site 105

Laguna Hills, California, 92655, United States

Location

Site 102

Petaluma, California, 92954, United States

Location

Site 109

Sacramento, California, 94206, United States

Location

Site 111

Grand Junction, Colorado, 81501, United States

Location

Site 103

Largo, Florida, 33770, United States

Location

Site 106

Oak Lawn, Illinois, 60453, United States

Location

Site 108

Alexandria, Minnesota, 56308, United States

Location

Site 104

St Louis, Missouri, 63131, United States

Location

Site 101

Somersworth, New Hampshire, 03878, United States

Location

Site 107

Sioux Falls, South Dakota, 57108, United States

Location

Site 110

San Antonio, Texas, 78229, United States

Location

Site 112

San Antonio, Texas, 78229, United States

Location

Related Publications (1)

• Hovanesian JA, Liang E, Desai NR, Berdy GJ, Karpuk K, Schweitzer J, Alexander A, Vittitow JL, Berdahl J, Bacharach J. Perfluorohexyloctane Ophthalmic Solution in Patients with Dry Eye Disease Undergoing Cataract Surgery: A Prospective Multicenter Study. Ophthalmol Ther. 2026 Jan 26. doi: 10.1007/s40123-025-01302-z. Online ahead of print.

  PMID: 41588216 DERIVED

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

perfluorohexyl-octan

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2024
• First Posted: April 4, 2024
• Study Start: April 30, 2024
• Primary Completion: February 24, 2025
• Study Completion: February 24, 2025
• Last Updated: April 15, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (12)