Dry EyePhase 4NCT06346340
A Study to Evaluate the Effect of Miebo™ on Preoperative Biometry/Keratometry and Postoperative Refractive Accuracy
A Phase 4 study testing Miebo in people with Dry Eye, run by Bausch & Lomb Incorporated at 12 sites in United States.
Trial summary
A Phase 4, Multicenter, Open-Label Study to Evaluate the Effect of Miebo™ on Preoperative Biometry/ Keratometry and Postoperative Refractive Accuracy 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 12 sitesUnited States
- Study dates
- 30 Apr 2024to 24 Feb 2025
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- The same eye must satisfy the below inclusion criteria (a-e):
- 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)
- Candidate for routine, uncomplicated cataract surgery (phacoemulsification with posterior chamber intraocular lens [IOL] implantation, not combined with any other surgery)
- In the Investigator's opinion, subject has potential postoperative pinhole Snellen visual acuity of at least 20/200 in both eyes
Show all 10Show fewer
- Tear film break-up time ≤10 sec at Visit 1
- Total CFS score ≥2 and ≤11 (ie, sum of inferior, superior, central, nasal, and temporal), using the National Eye Institute scale at Visit 1
- Ocular Surface Disease Index (OSDI) ≥23 at Visit 1
- Able and willing to follow instructions, including participation in all trial assessments and visits.
Who cannot join
- 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:
- History of eye trauma
- History of Stevens-Johnson syndrome
- Active blepharitis or lid margin inflammation
- DED 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
Show all 26Show fewer
- Abnormal cornea shape (keratoconus)
- Corneal epithelial defect or significant confluent staining or filaments
- History of herpetic keratitis
- Ocular or periocular rosacea
- Pterygium in either eye
- 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
- 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
- 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
- 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
- Have active ocular allergies or ocular allergies that are expected to be active during the trial period
- Have worn contact lenses within 1 month prior to Visit 1 or planned wear during the study
- 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
- Have active ocular or systemic infection (bacterial, viral, or fungal), including fever
- Female subjects who are pregnant, nursing, or planning a pregnancy
- 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.
- 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 drug
- 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
- Have taken isotretinoin (eg, Accutane, Myorisan, Claravis, Amnesteem) within 6 months prior to Visit 1
- 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.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Site 108
Alexandria, Minnesota, 56308
Site 111
Grand Junction, Colorado, 81501
Site 105
Laguna Hills, California, 92655
Site 103
Largo, Florida, 33770
Site 106
Oak Lawn, Illinois, 60453
Site 102
Petaluma, California, 92954
Site 109
Sacramento, California, 94206
Site 110
San Antonio, Texas, 78229
Site 112
San Antonio, Texas, 78229
Site 107
Sioux Falls, South Dakota, 57108
Site 101
Somersworth, New Hampshire, 03878
Site 104
St Louis, Missouri, 63131
About this study
Official title: A Phase 4, Multicenter, Open-Label Study to Evaluate the Effect of Miebo™ on Preoperative Biometry/ Keratometry and Postoperative Refractive Accuracy
A Phase 4, Multicenter, Open-Label Study to Evaluate the Effect of Miebo™ on Preoperative Biometry/ Keratometry and Postoperative Refractive Accuracy
Read the detailed description
The primary objective is to determine the effect of preoperative Miebo treatment on the accuracy of preoperative biometry/keratometry and predicted refraction in subjects with dry eye disease (DED) who are already scheduled for cataract surgery.
- Conditions
- Dry Eye
- Being tested
- Miebo
- 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
Miebo applied in both eyes 4 times per day for approximately 30 days before cataract surgery. Following the completion of the standard follow up, approximately 30 days after cataract surgery, subjects will begin a second regimen of Miebo , 4 times per day in both eyes, for approximately 30 days.
| Study group | Role | What they receive |
|---|---|---|
| Miebo treatment | Experimental | Not described Receives: Drug: Miebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Difference Between Absolute Deviations From Predicted Refractive Error in the Study Eye.
Mean difference between absolute deviations from predicted refractive error in the study eye at Visit 3 (Second Eye/Unilateral Postop Day 30 ± 7 days).
Measured: Assessed at Postop Day 30 ± 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2024
- Study start30 Apr 2024
- Primary completion24 Feb 2025
- Study completion24 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dry EyeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch & Lomb Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06346340
- Sponsor's protocol ID
- 936
- Status last verified
- Jun 2026
- First submitted
- 28 Mar 2024
- Last updated
- 6 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hovanesian JA, Liang E, Desai NR, Berdy GJ, Karpuk K, Schweitzer J, Alexander A, Vittitow JL, Berdahl J, Bacharach J. Perfluorohexyloctane Ophthalmic Solution in Patients with Dry Eye Disease Undergoing Cataract Surgery: A Prospective Multicenter Study. Ophthalmol Ther. 2026 Feb;15(2):817-829. doi: 10.1007/s40123-025-01302-z. Epub 2026 Jan 26.
PubMed 41588216
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 4, Multicenter, Open-Label Study to Evaluate the Effect of Miebo™ on Preoperative Biometry/ Keratometry and Postoperative Refractive Accuracy
- ClinicalTrials.gov ID
- NCT06346340
- Acronym / sponsor ID
- 936
- Conditions
- Dry Eye
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 30 Apr 2024 (actual)
- Primary completion
- 24 Feb 2025 (actual)
- Study completion
- 24 Feb 2025 (actual)
- First posted
- 4 Apr 2024 (actual)
- Results
- Posted 6 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase 4, Multicenter, Open-Label Study to Evaluate the Effect of Miebo™ on Preoperative Biometry/ Keratometry and Postoperative Refractive Accuracy
Detailed description
The primary objective is to determine the effect of preoperative Miebo treatment on the accuracy of preoperative biometry/keratometry and predicted refraction in subjects with dry eye disease (DED) who are already scheduled for cataract surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Miebo treatment | Experimental | Drug: Miebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- At least 18 years of age at the time of consent
- Able to provide written voluntary informed consent
- The same eye must satisfy the below inclusion criteria (a-e):
- Ocular Surface Disease Index (OSDI) ≥23 at Visit 1
- Able and willing to follow instructions, including participation in all trial assessments and visits.
Key exclusion criteria (26 listed)
- 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:
- Pterygium in either eye
- 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
- 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
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MieboMiebo applied in both eyes 4 times per day for approximately 30 days before cataract surgery. Following the completion of the standard follow up, approximately 30 days after cataract surgery, subjects will begin a second regimen of Miebo , 4 times per day in both eyes, for approximately 30 days. | Drug | Miebo treatment |
Primary outcome
Mean Difference Between Absolute Deviations From Predicted Refractive Error in the Study Eye.
Time frame: Assessed at Postop Day 30 ± 7 days
Mean difference between absolute deviations from predicted refractive error in the study eye at Visit 3 (Second Eye/Unilateral Postop Day 30 ± 7 days).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41588216Hovanesian JA, Liang E, Desai NR, Berdy GJ, Karpuk K, Schweitzer J, Alexander A, Vittitow JL, Berdahl J, Bacharach J. Perfluorohexyloctane Ophthalmic Solution in Patients with Dry Eye Disease Undergoing Cataract Surgery: A Prospective Multicenter Study. Ophthalmol Ther. 2026 Feb;15(2):817-829. doi: 10.1007/s40123-025-01302-z. Epub 2026 Jan 26.
- Individual participant dataSharing planned: No
Related trials for Dry Eye
Active, not recruiting
Clinical Study Evaluating Nordlys™ SWT IPL for Dry Eye Disease (DED) Due to MGD
Meibomian Gland Dysfunction, Dry Eye Disease
RecruitingPhase 2
Safety of Tofacitinib, an Oral Janus Kinase Inhibitor, in Primary Sjogren Disease
Sjogren's Syndrome
Not yet recruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
Not yet recruiting
MYTP01 for Immune-Mediated Diseases
IgA Nephropathy, Kidney Transplant Recipients
Not yet recruitingEarly Phase 1
a Novel siRNA Eyedrops for DED Treatment
Dry Eye
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Miebo 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 10 inclusion and 26 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 6 Jul 2026. 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. 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?
Yes. Results are posted in the registry (first posted 6 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Difference Between Absolute Deviations From Predicted Refractive Error in the Study Eye. (time frame: Assessed at Postop Day 30 ± 7 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 NCT06346340, which also lists 1 linked publication.
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 6 Jul 2026.