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Can a new eye drop help contact lens wearers beat dry eye?

NCT ID NCT07054606

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether Miebo eye drops (perfluorohexyloctane) can safely and effectively relieve dry eye symptoms in people who wear soft contact lenses. 104 adults used the drops up to four times daily, both before and while wearing their lenses. Researchers measured changes in dry eye symptoms using a standard questionnaire.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
perfluorohexyloctane eye drops (Miebo)
What this could lead to
If it works, this could offer a new option for contact lens users to manage dry eye symptoms without removing their lenses.
What could go wrong
This is a small, completed Phase 4 trial with only 104 participants. Results may not apply to everyone, and the drops might not work for all types of dry eye.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

104 people

The number who actually took part.

Started

Jul 2025

Finished

Nov 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. At least 18 years of age at the time of consent 2. 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) 3. 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. 4. 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). 5. 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 6. Able and willing to follow instructions, including participation in all trial assessments and visits 7. Be willing to submit to urine pregnancy test at Visits 1 and 4 for female subjects of childbearing potential. 8. 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). 9. 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. Exclusion Criteria: 1. 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). 2. Subjects who are non-contact lens wearers or who have changed contact lens type/brand within the last 6 months 3. 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) 4. 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: 1. History of Stevens-Johnson syndrome 2. Active blepharitis or lid margin inflammation 3. Dry eye disease secondary to scarring, irradiation, alkali burns, cicatricial pemphigoid, or destruction of conjunctival goblet cells (as with vitamin A deficiency) 4. Abnormal lid anatomy causing incomplete eyelid closure 5. Abnormal cornea shape (keratoconus) 6. Corneal epithelial defect or significant confluent staining or filaments 7. History of ocular malignancy 5. Pterygium or pinguecula in either eye that, in the opinion of the Investigator, could interfere with fit of a soft contact lens 6. 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 7. 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 8. Have active uncontrolled ocular allergies or ocular allergies that are expected to be active during the trial period 9. 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 10. Planning to undergo an ocular surgical intervention (e.g., intraocular surgery, ocular surgery, cataract surgery, LASIK, etc.) in either eye during the trial period. 11. Have active ocular or systemic infection (bacterial, viral, or fungal), including fever 12. 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). 13. Female subjects who are pregnant, nursing, or planning a pregnancy 14. 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 15. 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. 16. Have an uncontrolled systemic disease that, in the opinion of the Investigator, will interfere with the trial 17. Have a known allergy and/or sensitivity to the Investigational Product or diagnostic substances (e.g., fluorescein) to be used in the study 18. Are currently enrolled in any investigational drug or device study or have used Miebo within 30 days prior to Visit 1

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Site 101

    San Diego, California, 92307, United States

  • Site 102

    Medina, Minnesota, 55340, United States

  • Site 103

    Athens, Ohio, 45701, United States

  • Site 104

    Pittsburg, Kansas, 66762, United States

  • Site 107

    Longwood, Florida, 32779, United States

  • Site 108

    Vestal, New York, 13850, United States

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