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100 Participants NeededMy employer runs this trial

Miebo for Dry Eye

(Sonoran Trial)

Recruiting at 3 trial locations
KK
Overseen ByKayla Karpuk, OD
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: Vance Thompson Vision
Must not be taking: Ocular steroids, Dry eye therapy, Antihistamines, Antidepressants
Disqualifiers: Ocular allergies, Active infection, Pregnancy, others
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

Compare eye dryness following laser-assisted in situ keratomileusis (LASIK) surgery to eye dryness prior to receiving perioperative Miebo in patients with dry eye disease (DED)

Are You a Good Fit for This Trial?

This trial is for adults with mild to moderate dry eye disease who are planning routine LASIK surgery. Participants must not have had prior eye surgeries, active eye allergies or infections, recent use of certain eye treatments, or abnormal corneas. Pregnant or nursing women and those unable to follow study instructions cannot join.

Inclusion Criteria

I am eligible for standard LASIK surgery for nearsightedness or myopic astigmatism.
Ocular Surface Disease Index (OSDI) ≥13 and ≤22 at Visit 1
Total CFS score ≥1 and ≤6 using the National Eye Institute scale at Visit 1 in at least one eye
See 2 more

Exclusion Criteria

I have had eye surgery or laser treatment in my study eye within the last 3 months.
I am currently pregnant, breastfeeding, or planning to become pregnant.
Ocular allergies active or expected to be active during trial period
See 14 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Miebo instilled four times per day to each eye perioperatively

4 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Miebo

Trial Overview

The study tests Miebo eye drops (used four times daily) before and after LASIK surgery in people with dry eyes. It aims to see if Miebo helps reduce dryness caused by the procedure compared to dryness levels before treatment.

How Is the Trial Designed?

1

Treatment groups

Active Control

Group I: MieboActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Vance Thompson Vision

Lead Sponsor

Trials
11
Recruited
300+

Bausch & Lomb Incorporated

Industry Sponsor

Trials
263
Recruited
59,400+
Dr. Christina Ackermann profile image

Dr. Christina Ackermann

Bausch & Lomb Incorporated

Chief Medical Officer since 2023

MD from Harvard Medical School

Brent Saunders profile image

Brent Saunders

Bausch & Lomb Incorporated

Chief Executive Officer since 2023

BA from the University of Pittsburgh, JD and MBA from Temple University

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