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Dry EyePhase 4NCT07054606

A Study to Evaluate Concomitant Perfluorohexyloctane Use With Contact Lens Wear

A Phase 4 study testing Perfluorohexyloctane ophthalmic solution in people with Dry Eye, run by Bausch & Lomb Incorporated at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Assess the impact of concomitant Miebo use while wearing contact lenses 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?
Perfluorohexyloctane ophthalmic solution
Could I receive a placebo?
No, everyone receives an active treatment
How many people
104 participants
Where
6 sitesUnited States
Study dates
2 Jul 2025to 3 Nov 2025
Phase
Phase 4
Are there results?
None posted in the registry

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

  • At least 18 years of age at the time of consent
  • Able to provide written voluntary informed consent and sign the Health Insurance Portability and Accountability Act (HIPAA) form as well as the Experimental Subjects Bill of Rights(for subjects in California)
  • Subject must have a documented Manifest Refraction by the PI (or sub-investigator at the same site) performed in the past 180 days prior to screening.
  • Currently wearing soft, frequent-replacement lenses bilaterally (daily-disposable, bi-weekly, or monthly lenses that are available in the US), that have been worn habitually for a minimum of 5 days/week for 6 hours/day over the last 6 months prior to Visit 1 and is willing to wear them for at least 6 hours/day every day during the study (i.e., 30 consecutive days of contact lens wear). Almost all soft contact lenses qualify for study (see exclusion criterion #2 below).
  • Achieves acceptable lens fit as well as ETDRS VA correctable with contact lenses to +0.20 logMAR or better in each eye at Visit 1
  • Able and willing to follow instructions, including participation in all trial assessments and visits
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  • Be willing to submit to urine pregnancy test at Visits 1 and 4 for female subjects of childbearing potential.
  • Female subjects of childbearing potential must agree to use 1 medically acceptable method 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. True abstinence may be regarded as an acceptable method of birth control (when this is in line with the preferred and usual lifestyle of the subject); however, if the subject becomes sexually active during the trial, she must use an acceptable method of birth control as defined above for the remainder of the trial. Note: Females of childbearing potential include all females who have experienced menarche and have not experienced menopause (as defined by amenorrhea for greater than 12 consecutive months) or have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy).
  • Male subjects with a female partner of childbearing potential, must use at least 1 medically acceptable method of birth control. Note: Acceptable methods of birth control are true abstinence (when this is in line with the preferred and usual lifestyle of the subject) or vasectomy at least 3 months prior to receiving Investigational Product. Without a vasectomy, condoms with spermicide must be used throughout the study duration.

Who cannot join

  • Subjects who do not have a documented Manifest Refraction within 180 days prior to Visit 1 by the Principal Investigator (or sub-investigator at the same site).
  • Subjects who are non-contact lens wearers or who have changed contact lens type/brand within the last 6 months
  • Subjects who wear scleral lenses, rigid gas-permeable lenses, hybrid lenses, custom soft contact lenses with a replacement schedule >30 days, or soft contact lenses on an extended-wear basis (i.e., AirOptix Night and Day contact lenses and other lenses approved for overnight wear)
  • Have any clinically significant ocular surface slit-lamp findings in either eye and/or, in the opinion of the Investigator, have any findings that could interfere with trial parameters or impact a subject's ability to wear contact lenses throughout the study, including:
  • History of Stevens-Johnson syndrome
  • Active blepharitis or lid margin inflammation
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  • Dry eye disease 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 ocular malignancy
  • Pterygium or pinguecula in either eye that, in the opinion of the Investigator, could interfere with fit of a soft contact lens
  • Use of any of the following ocular therapies in either eye within 30 days prior to Visit 1: Vuity®, topical ocular steroid treatments, topical antibiotics, topical anti-allergy medications, prescription dry eye therapy including varenicline nasal spray, or topical anti-glaucoma medication
  • Use of any eye drops (prescription or over-the-counter, such as artificial tears, re-wetting drops, RYZUMVITM, or Lumify®) and/or TrueTear™ device (intranasal tear neurostimulator) in either eye within 24 hours prior to Visit 1, or plan to use these therapies during the course of the study
  • Have active uncontrolled ocular allergies or ocular allergies that are expected to be active during the trial period
  • Have undergone intraocular surgery or ocular laser surgery in either eye within 3 months prior to Visit 1; have undergone refractive surgery in either eye within 1 year prior to Visit 1
  • Planning to undergo an ocular surgical intervention (e.g., intraocular surgery, ocular surgery, cataract surgery, LASIK, etc.) in either eye during the trial period.
  • Have active ocular or systemic infection (bacterial, viral, or fungal), including fever
  • Be unwilling to submit to a urine pregnancy test at Visits 1 and 4 for women of childbearing potential. Note: Females of childbearing potential include all females who have experienced menarche and have not experienced menopause (as defined by amenorrhea for greater than 12 consecutive months or have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy).
  • Female subjects who are pregnant, nursing, or planning a pregnancy
  • Female subjects of childbearing potential who are not using 1 acceptable method 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. True abstinence may be regarded as an acceptable method of birth control; however, if the subject becomes sexually active during the trial, she must agree to use 1 acceptable method of birth control as defined above for the remainder of the trial
  • Male subjects with a female partner of childbearing potential, who is not willing to use 1 acceptable method of birth control throughout the study. Note: Acceptable methods of birth control are true abstinence (when this is in line with the preferred and usual lifestyle of the subject) or unwilling to use condoms with spermicide if he has not had a vasectomy at least 3 months prior to receiving Investigational Product.
  • Have an uncontrolled systemic disease that, in the opinion of the Investigator, will interfere with the trial
  • Have a known allergy and/or sensitivity to the Investigational Product or diagnostic substances (e.g., fluorescein) to be used in the study
  • Are currently enrolled in any investigational drug or device study or have used Miebo within 30 days prior to Visit 1

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • Site 103

    Athens, Ohio, 45701

  • Site 107

    Longwood, Florida, 32779

  • Site 102

    Medina, Minnesota, 55340

  • Site 104

    Pittsburg, Kansas, 66762

  • Site 101

    San Diego, California, 92307

  • Site 108

    Vestal, New York, 13850

Other trials in United States

About this study

Official title: A Phase 4, Multicenter, Open-Label Study to Evaluate Concomitant Perfluorohexyloctane Use With Contact Lens Wear

Assess the impact of concomitant Miebo use while wearing contact lenses

Conditions
Dry Eye
Being tested
Perfluorohexyloctane ophthalmic solution
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.

  • Perfluorohexyloctane ophthalmic solutionDrug

    Eligible subjects will receive Miebo up to 4 times bilaterally on Day 1/Visit 1 (1 drop instilled bilaterally by site staff in-clinic while wearing contact lenses and the rest self-administered throughout the remainder of the day while wearing contact lenses). Starting on Day 2, subjects will self-administer the first drop of Miebo bilaterally before inserting contact lenses for the day. Subjects will wait 30 minutes after the first dose of Miebo to insert their contact lenses and will then instill 3 additional drops of Miebo while wearing contact lenses approximately evenly spaced throughout the rest of the day. Subjects will continue to self-administer Miebo QID bilaterally following the dosing schedule from Day 2 for approximately 30 days. Subjects are expected to record daily VAS assessments throughout the study. The VAS assessments will be collected by the sites at Visits 2, 3, and 4.

Study groups in NCT07054606
Study groupRoleWhat they receive
Miebo (perfluorohexyloctane ophthalmic solution)ExperimentalNot described
Receives: Drug: Perfluorohexyloctane ophthalmic solution

What is being measured

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

  1. Change from baseline (CFB) in CLDEQ-8 score at Visit 4

    Unabbreviated scale title: Contact Lens Dry Eye Questionnaire-8 Min: 1 Max: 37 Higher scores mean worse.

    Measured: Assessed for approximately 30 days

Timeline

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

  1. First posted8 Jul 2025
  2. Study start2 Jul 2025
  3. Primary completion3 Nov 2025
  4. Study completion3 Nov 2025

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
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
104 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07054606
Sponsor's protocol ID
BL-RX01-BAJA-1403
Status last verified
Dec 2025
First submitted
27 Jun 2025
Last updated
18 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Perfluorohexyloctane ophthalmic solution in people with Dry Eye, run by Bausch & Lomb Incorporated at 6 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 9 inclusion and 25 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: finished, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Change from baseline (CFB) in CLDEQ-8 score at Visit 4 (time frame: Assessed for approximately 30 days). 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 NCT07054606.

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 18 Dec 2025.

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