Dry eye drops may sharpen cataract surgery outcomes

NCT ID NCT06346340

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 06, 2026 · Last updated Jul 07, 2026 · Updated 1 time

Summary

This study tests whether Miebo eye drops, used before and after cataract surgery, can improve the accuracy of lens measurements and final vision in people with dry eye. Participants apply the drops four times daily for about 30 days before surgery and again for 30 days after. The goal is to see if treating dry eye leads to better surgical outcomes.

What this could mean

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

Active substance
Miebo (eye drops)
What this could lead to
If it works, this could show that treating dry eye before cataract surgery improves the accuracy of lens measurements and final vision.
What could go wrong
This is a small, open-label study, so results may be less reliable than a blinded trial. The benefit may not apply to all dry eye patients.

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

97 people

The number who actually took part.

Started

Apr 2024

Finished

Feb 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 3. The same eye must satisfy the below inclusion criteria (a-e): 1. At least 1 eye with a visually significant cataract that has been scheduled for cataract surgery (eligible eye can be a subject's second eye to undergo cataract surgery as long as all eligibility criteria are met in that eye) 2. Candidate for routine, uncomplicated cataract surgery (phacoemulsification with posterior chamber intraocular lens \[IOL\] implantation, not combined with any other surgery) 3. In the Investigator's opinion, subject has potential postoperative pinhole Snellen visual acuity of at least 20/200 in both eyes 4. Tear film break-up time ≤10 sec at Visit 1 5. Total CFS score ≥2 and ≤11 (ie, sum of inferior, superior, central, nasal, and temporal), using the National Eye Institute scale at Visit 1 4. Ocular Surface Disease Index (OSDI) ≥23 at Visit 1 5. Able and willing to follow instructions, including participation in all trial assessments and visits. Exclusion Criteria: 1. Have any clinically significant ocular surface slit-lamp findings in the study eye and/or, in the opinion of the Investigator, have any findings that could interfere with trial parameters, including: 1. History of eye trauma 2. History of Stevens-Johnson syndrome 3. Active blepharitis or lid margin inflammation 4. DED secondary to scarring, irradiation, alkali burns, cicatricial pemphigoid, or destruction of conjunctival goblet cells (as with vitamin A deficiency) 5. Abnormal lid anatomy causing incomplete eyelid closure 6. Abnormal cornea shape (keratoconus) 7. Corneal epithelial defect or significant confluent staining or filaments 8. History of herpetic keratitis 9. Ocular or periocular rosacea 2. Pterygium in either eye 3. Use of any of the following ocular therapies in the study eye within 30 days prior to Visit 1: Vuity®, Qlosi™, topical ocular steroid treatments, prescription dry eye therapy including varenicline nasal spray, or topical anti-glaucoma medication 4. Had a LipiFlow® procedure, intense pulse light procedure, or any kind of other procedure affecting meibomian glands in the study eye within 3 months prior to Visit 1 5. Had received or removed a permanent punctum plug in the study eye within 1 month (3 months for dissolvable punctum plugs) prior to Visit 1 6. Use of any eye drops (prescription or over-the-counter, such as artificial tears or Lumify®) and/orTrueTear™ device (intranasal tear neurostimulator) in the study eye within 24 hours prior to Visit 1 7. Have active ocular allergies or ocular allergies that are expected to be active during the trial period 8. Have worn contact lenses within 1 month prior to Visit 1 or planned wear during the study 9. Have undergone intraocular surgery or ocular laser surgery in the study eye within 3 months prior to Visit 1; have undergone refractive surgery in the study eye within 2 years prior to Visit 1 10. Have active ocular or systemic infection (bacterial, viral, or fungal), including fever 11. Female subjects who are pregnant, nursing, or planning a pregnancy 12. Female subjects of childbearing potential who are not using an acceptable means 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. For non-sexually active female subjects, abstinence may be regarded as an adequate method of birth control; however, if the subject becomes sexually active during the trial, she must agree to use adequate birth control as defined above for the remainder of the trial. 13. Have an uncontrolled systemic disease that, in the opinion of the Investigator, will interfere with the trial 14. Have a known allergy and/or sensitivity to the investigational drug 15. Use of any oral medications known to cause ocular drying (eg, antihistamines, antidepressants, etc.) on a non-stable regimen within 1 month prior to Visit 1 or is expected to be unstable during the trial 16. Have taken isotretinoin (eg, Accutane, Myorisan, Claravis, Amnesteem) within 6 months prior to Visit 1 17. Are currently enrolled in an investigational drug or device study or had used an investigational drug or device within 60 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

    Somersworth, New Hampshire, 03878, United States

  • Site 102

    Petaluma, California, 92954, United States

  • Site 103

    Largo, Florida, 33770, United States

  • Site 104

    St Louis, Missouri, 63131, United States

  • Site 105

    Laguna Hills, California, 92655, United States

  • Site 106

    Oak Lawn, Illinois, 60453, United States

  • Site 107

    Sioux Falls, South Dakota, 57108, United States

  • Site 108

    Alexandria, Minnesota, 56308, United States

  • Site 109

    Sacramento, California, 94206, United States

  • Site 110

    San Antonio, Texas, 78229, United States

  • Site 111

    Grand Junction, Colorado, 81501, United States

  • Site 112

    San Antonio, Texas, 78229, United States

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