Dry Eye
Conditions
Brief summary
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.
Interventions
DRUGMiebo
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.
Sponsors
Bausch & Lomb Incorporated
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Difference Between Absolute Deviations From Predicted Refractive Error in the Study Eye. | 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). |
Countries
United States
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 72 Participants |
| Age, Categorical Between 18 and 65 years | 25 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants |
| Race (NIH/OMB) Asian | 6 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 78 Participants |
| Region of Enrollment United States | 97 participants |
| Sex: Female, Male Female | 73 Participants |
| Sex: Female, Male Male | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 97 |
| other Total, other adverse events | 5 / 97 |
| serious Total, serious adverse events | 2 / 97 |
Outcome results
None listed