A Study to Evaluate Early Treatment Outcomes With Miebo™ in Subjects With Dry Eye Disease

NCT06309953 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 937
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 7

Brief Summary

An Open-Label, Multicenter, Phase 4 Study to Evaluate Early Treatment Outcomes With Miebo™ in Subjects With Dry Eye Disease

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (1)

• Mean Change From Baseline (CFB) in Dry Eye Symptom Severity at Visit 3

  Mean change from baseline (CFB) in dry eye symptom severity at Visit 3 (Day 7 ± 1 day) Scale name: Visual Analog Scale Range: min: 0%, max: 100%; 0% corresponds to "none" and 100% corresponds to "worst severity possible" Intrepretation: VAS is a subjective measurement tool that consists of a horizontal assessment line, of 100 mm (10 cm) length where patients place a vertical mark to indicate the level of perceived severity of symptoms. Higher values indicate worse disease severity, lower values indicate better outcome with treatment

  Change from baseline in VAS at Visit 3 (Day 7 ± 1 day)

Study Arms (1)

Miebo treatment

EXPERIMENTAL

Drug: Miebo

Interventions

Miebo DRUG

Miebo® (perfluorohexyloctane ophthalmic solution) Dosage: one drop of MIEBO four times daily into each eye Dosage form: Ophthalmic solution: 100% perfluorohexyloctane. Frequency: 4 times daily for 14 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
• Subject-reported history of DED in at least 1 eye for at least 6 months prior to Visit 1
• Tear-film break-up time ≤5 seconds at Visit 1
• Total corneal fluorescein staining score ≥4 and ≤11 (ie, sum of inferior, superior, central, nasal, and temporal) according to the National Eye Institute scale at Visit 1
• Total meibomian gland dysfunction score ≥3 (range, 0-15)
• Unanesthetized Schirmer's test I score ≥5 mm
• Ocular Surface Disease Index (OSDI) ≥25 at Visit 1
• Able and willing to follow instructions, including participation in all trial assessments and visits.

You may not qualify if:

• Had received Miebo as a prescription or as a study treatment in previous Miebo clinical studies
• Have any clinically significant ocular surface slit lamp findings at Visit 1 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 or filaments
• History of herpetic keratitis
• Pterygium
• Ocular or periocular rosacea
• Use of any of the following ocular therapies within 60 days prior to Visit 1: Vuity®, any 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 within 6 months prior to Visit 1
• Had received or removed a permanent punctum plug within 3 months (6 months for dissolvable plugs) prior to Visit 1

Sponsors & Collaborators

• Bausch & Lomb Incorporated: lead

Study Sites (7)

Site 207

Birmingham, Alabama, 35233, United States

Location

Site 205

Petaluma, California, 94954, United States

Location

Site 203

Pittsburg, Kansas, 66762, United States

Location

Site 204

Stillwater, Minnesota, 55082, United States

Location

Site 202

Kansas City, Missouri, 64154, United States

Location

Site 201

Brecksville, Ohio, 44141, United States

Location

Site 206

Westlake, Ohio, 44145, United States

Location

Related Publications (1)

• Bacharach J, Kannarr SR, Verachtert A, Gupta PK, Razeen M, Cavet ME, Vittitow JL, Lang J, Chester TM, Ziemanski JF, White DE. Early Effects of Perfluorohexyloctane Ophthalmic Solution on Patient-Reported Outcomes in Dry Eye Disease: A Prospective, Open-Label, Multicenter Study. Ophthalmol Ther. 2025 Apr;14(4):693-704. doi: 10.1007/s40123-025-01097-z. Epub 2025 Feb 22.

  PMID: 39985746 DERIVED

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

perfluorohexyl-octan

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Results Point of Contact

• Title: Jason Vittitow, PhD
• Organization: Bausch & Lomb

jason.vittitow@bausch.com

908-541-3060

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

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 7, 2024
• First Posted: March 13, 2024
• Study Start: February 28, 2024
• Primary Completion: June 17, 2024
• Study Completion: June 17, 2024
• Last Updated: October 21, 2025
• Results First Posted: October 21, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)