| Eligibility |
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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