A Study to Evaluate Corneal Endothelial Cell Density (ECD) in Subjects With Dry Eye Disease (DED) Administering Miebo® (Perfluorohexyloctane Ophthalmic Solution) for 12 Months.

NCT06565650 | Active Not Recruiting Phase 4 FDA Drug

• 1 other identifier: 933
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 12

Brief Summary

A Randomized, Multicenter, Double-Masked, Saline-Controlled Trial to Evaluate Corneal Endothelial Cell Density in Subjects With Dry Eye Disease Administering Miebo® (Perfluorohexyloctane Ophthalmic Solution) for 12 Months

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (1)

• Mean change from baseline in ECD

  Mean change from baseline in ECD in the study eye at the Month 3 and Month 12 Visits

  Assessed at Month 3 and Month 12 Visits

Study Arms (2)

Miebo

EXPERIMENTAL

100% perfluorohexyloctane 4 times daily (QID)

Drug: Miebo

Saline solution

PLACEBO COMPARATOR

(0.6% sodium chloride solution) 4 times daily (QID)

Drug: Saline

Interventions

Miebo DRUG

100% perfluorohexyloctane

Miebo

Saline DRUG

0.6% sodium chloride solution

Saline solution

Eligibility Criteria

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

You may qualify if:

• Be at least 18 years of age at the time of consent.
• Have a self-reported history of DED in both eyes (OU) for at least 6 months prior to Visit 1 (Screening/Baseline)
• Have a total corneal fluorescein staining score (tCFS) score \>2 in both eyes
• Have an Ocular Surface Disease Index (OSDI) score \>17
• Have a baseline ECD ≥1750 cells/mm2 in each eye
• Provide written informed consent
• Be able and willing to follow instructions, including participation in all trial assessments and visits
• If a contact lens wearer, be willing to discontinue contact lens use during and for 30 minutes following instillation of investigational drug and during study visits

You may not qualify if:

• Be at least 18 years of age at the time of consent.
• Have a self-reported history of DED in both eyes (OU) for at least 6 months prior to Visit 1 (Screening/Baseline)
• Have a total corneal fluorescein staining score (tCFS) score \>2 in both eyes
• Have an Ocular Surface Disease Index (OSDI) score \>17
• Have a baseline ECD ≥1750 cells/mm2 in each eye
• Provide written informed consent
• Be able and willing to follow instructions, including participation in all trial assessments and visits
• If a contact lens wearer, be willing to discontinue contact lens use during and for 30 minutes following instillation of investigational drug and during study visits
• Have any clinically significant ocular surface slit lamp findings and/or in the opinion of the Investigator have any findings that may interfere with trial parameters in either eye
• Have an ocular or periocular malignancy in either eye
• Have a history of herpetic keratitis in either eye
• Have any planned ocular and/or lid surgeries in either eye during the course of the study
• Have a known allergy and/or sensitivity to the IP
• Have a history of ocular laser surgery in either eye within 3 months (90 days) prior to Visit 1 (Screening/Baseline)
• Have a history of incisional ocular surgery or severe trauma in either eye within 3 months (90 days) prior to Visit 1 (Screening/Baseline)

Sponsors & Collaborators

• Bausch & Lomb Incorporated: lead

Study Sites (12)

Site 101

Glendale, California, 91204, United States

Location

Site 112

Murrieta, California, 92562, United States

Location

Site 102

Newport Beach, California, 92663, United States

Location

Site 109

Rancho Cordova, California, 95670, United States

Location

Site 106

Torrance, California, 90505, United States

Location

Site 113

Delray Beach, Florida, 33484, United States

Location

Site 107

Morrow, Georgia, 30260, United States

Location

Site 105

Carmel, Indiana, 46290, United States

Location

Site 110

Kansas City, Missouri, 64111, United States

Location

Site 104

St Louis, Missouri, 63131, United States

Location

Site 108

Asheville, North Carolina, 28803, United States

Location

Site 103

Memphis, Tennessee, 38119, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

perfluorohexyl-octan; Sodium Chloride

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Subjects will be instructed not to show or discuss the properties of the assigned Investigational Product (IP) and/or their experience with the IP with other subjects and not to show or discuss the IP with the Investigator or site personnel other than the dedicated dosing coordinator, unless instructed to do so.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2024
• First Posted: August 22, 2024
• Study Start: July 31, 2024
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: December 17, 2024

Record last verified: 2024-12

Locations

US (12)