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Dry EyePhase 4NCT06565650

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

A Phase 4 study testing Miebo and Saline in people with Dry Eye, run by Bausch & Lomb Incorporated at 12 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Dry Eye
What is being tested?
Miebo and Saline
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
216 participants
Where
12 sitesUnited States
Study dates
31 Jul 2024to Nov 2025
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 21Show fewer
  • 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)
  • Have high contrast best-corrected visual acuity equal to or worse than logMAR +0.7 (Snellen equivalent score of 20/100 or worse) as assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) scale in either eye, obtained under bright room lighting
  • Be a woman who is pregnant, nursing or planning a pregnancy during the course of the study
  • Be a woman of childbearing potential who is unwilling to submit to a urine pregnancy test. Non-childbearing potential is defined as a woman who is permanently sterilized (eg, has had a hysterectomy or bilateral tubal ligation or bilateral oophorectomy) or is postmenopausal (without menses for 12 consecutive months).
  • Be a woman of childbearing potential who is not using an acceptable method of birth control. Acceptable methods of contraception include hormonal - oral, implantable, injectable, or transdermal - contraceptives; mechanical contraception - spermicide in conjunction with a barrier such as a diaphragm or condom; intrauterine device; or surgical sterilization of partner. For non-sexually active females, abstinence may be regarded as an adequate method of birth control; however, the subject must agree to use adequate birth control as defined above for the remainder of the study if she becomes sexually active during the trial.
  • Be currently enrolled in an investigational drug or device trial or plan to enroll during the course of the study
  • Have a condition or be in a situation that the Investigator believes may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

United States12 sites

  • Site 108

    Asheville, North Carolina, 28803

  • Site 105

    Carmel, Indiana, 46290

  • Site 113

    Delray Beach, Florida, 33484

  • Site 101

    Glendale, California, 91204

  • Site 110

    Kansas City, Missouri, 64111

  • Site 103

    Memphis, Tennessee, 38119

  • Site 107

    Morrow, Georgia, 30260

  • Site 112

    Murrieta, California, 92562

  • Site 102

    Newport Beach, California, 92663

  • Site 109

    Rancho Cordova, California, 95670

  • Site 104

    St Louis, Missouri, 63131

  • Site 106

    Torrance, California, 90505

Other trials in United States

About this study

Official title: 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.

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
Being tested
Miebo, Saline
Medical subject headings
Dry Eye Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MieboDrug

    100% perfluorohexyloctane

  • SalineDrug

    0.6% sodium chloride solution

Study groups in NCT06565650
Study groupRoleWhat they receive
MieboExperimental100% perfluorohexyloctane 4 times daily (QID)
Receives: Drug: Miebo
Saline solutionPlacebo comparator(0.6% sodium chloride solution) 4 times daily (QID)
Receives: Drug: Saline

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Assessed at Month 3 and Month 12 Visits

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Aug 2024
  2. Study start31 Jul 2024
  3. Primary completionNov 2025 (estimated)
  4. Study completionNov 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
216 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06565650
Sponsor's protocol ID
933
Status last verified
Dec 2024
First submitted
20 Aug 2024
Last updated
17 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Miebo and Saline in people with Dry Eye, run by Bausch & Lomb Incorporated at 12 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 17 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean change from baseline in ECD (time frame: Assessed at Month 3 and Month 12 Visits). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06565650.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2024.

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