| Eligibility |
Inclusion Criteria:
Subjects must meet all the following requirements to be eligible for enrollment into the
study.
1. Be at least 18 years of age;
2. Provide written informed consent;
3. Have a self-reported history of dry eye for at least 6 months prior to Visit 1;
4. Have a history of use or desire to use eye drops for dry eye symptoms for at least 6
months prior to Visit 1;
5. Report a score of = 2 according to a 0-5 point scale in at least one symptom of the
Ora Calibra Ocular Discomfort & 4-Symptom Questionnaire pre-CAE at Visits 1 and 2;
6. Have a conjunctival redness score of = 1 according to a 0-4 point scale in at least
one eye at Visits 1 and 2;
7. Have a tear film break-up time (TFBUT) >1 and < 7 seconds in at least one eye pre-CAE
at Visit 1 and 2;
8. Have an unanesthetized Schirmer's Test score of = 10 mm and = 1 mm in at least one eye
pre-CAE at Visits 1 and 2;
9. Have a corneal fluorescein staining sum of = 6 according to a 0-4 point scale (sum of
inferior, superior, and central) in at least one eye pre-CAE at Visits 1 and 2;
10. Have a central corneal fluorescein staining score of = 1 according to a 0-4 point in
at least one eye pre-CAE at Visits 1 and 2;
11. Have a total lissamine green conjunctival score of = 2, based on the sum of the
temporal and nasal regions of the conjunctiva according to a 0-4 point scale in at
least one eye pre-CAE at Visits 1 and 2;
12. Demonstrate a response to the CAE at Visits 1 and 2 as defined by:
1. Having at least a = 1 point increase in fluorescein staining in the inferior
region in at least one eye following CAE exposure; and
2. Reporting an Ocular Discomfort score = 3 at 2 or more consecutive time points in
at least one eye during CAE exposure (if a subject has an Ocular Discomfort
rating of 3 at time = 0 for an eye, s/he must report an Ocular Discomfort rating
of 4 for two consecutive measurements for that eye).
13. Have at least one eye (the same eye) satisfy all criteria for 6, 7, 8, 9, 10, 11, and
12 above.
Exclusion Criteria:
Subjects may not participate in the study if any of the following criteria are met:
1. Unable or unwilling to follow instructions, including participation in all study
assessments and visits;
2. Have active blepharitis, meibomian gland dysfunction (MGD) or lid margin inflammation
that required any topical or systemic antibiotics or topical steroids or other
prescription medical treatment or treatment with hypochlorous acid wipes within the
last 3 months prior to Visit 1 or will require such treatment during the trial.
Any other therapy such as lid scrubs, lid wipes, warm compresses have to be stable
within the last 3 months prior to Visit 1 and the subject should be willing to
continue those therapies through the trial
3. Have active ocular allergies that require therapeutic treatment, and/or in the opinion
of the Investigator may interfere with study parameters;
4. Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active
ocular inflammation at Visit 1;
5. Have a significant ocular lesion that the investigator feels might affect ocular
surface staining score;
6. Have worn contact lenses within 14 days of Visit 1 or anticipate using contact lenses
during the study;
7. Have previously had laser-assisted in situ keratomileusis (LASIK) or any other Laser
refractive surgery within the last 12 months or any other ocular surgeries within the
last 6 months;
8. Have any planned ocular and/or lid surgeries over the study period;
9. Current smoker (includes tobacco, marijuana, or vaping) or has smoked within 6 months
of Visit 1;
10. Has dry eye secondary to known systemic diseases or comorbidities:
1. Previous diagnosis of graft versus host disease or cicatrizing conjunctivitis
(e.g., Steven-Johnson Syndrome, mucous membrane pemphigoid, trachoma, trauma);
2. Anatomical or neurological lid closure problems (e.g., Bell's palsy, cicatricial
ectropion, Alzheimer's disease, Parkinson's disease);
11. Has dry eye secondary to other ocular surface diseases or ocular surgery:
1. Ocular rosacea, blepharitis, demodex infestation, atopic keratoconjunctivitis,
etc.;
2. Any history of surgery for glaucoma (e.g., trabeculectomy, tube shunt);
3. Cataract, eyelid surgery, or retinal surgery (in operating room) within 6 months
prior to enrollment;
4. Any in-office dry eye procedures (e.g., Intense Pulsed Light [IPL], LipiFlow ,
nasolacrimal duct probing) within 90 days prior to enrollment;
12. Has a history of corneal dystrophy that in the opinion of the investigator is
significantly affecting the ocular surface (e.g., significant anterior basement
membrane dystrophy, Fuch's dystrophy with significant corneal edema and bullae,
neurotrophic keratoconjunctivitis or corneal/conjunctival scarring including herpes
simplex virus [HSV] or varicella zoster virus [VZV] keratitis);
13. Has any physical or mental condition interfering with the successful participation in
this study;
14. Has had any past head and neck radiation treatment;
15. Be using or anticipate using temporary punctal plugs;
16. Be using or anticipate using permanent punctal plugs during the study that have not
been stable within 3 months of Visit 1;
17. Have had punctal occlusion (other than permanent punctal plugs) within 6 months of
Visit 1;
18. Have corrected visual acuity greater than or equal to logMAR+0.7 as assessed by Early
Treatment of Diabetic Retinopathy Study (ETDRS) scale in either eye at Visit 1
19. Have an uncontrolled systemic disease;
20. Be a woman who is pregnant, nursing or planning a pregnancy;
21. Be unwilling to submit a urine pregnancy test at Visit 1 and Visit 5 (or early
termination visit) if a woman of childbearing potential (WOCBP). Non-childbearing
potential is defined as a woman who is permanently sterilized (e.g. has had a
hysterectomy or tubal ligation), or is post-menopausal (without menses for 12
consecutive months);
22. Be a woman of childbearing potential (WOCBP) who does not have a negative pregnancy
test at Screening or who does not agree to use an acceptable means of birth control;
acceptable methods of contraception include: hormonal - oral, implantable, injectable,
or transdermal contraceptives; mechanical - spermicide in conjunction with a barrier
such as a diaphragm or condom; IUD; surgical sterilization of partner; For
non-sexually active females, abstinence may be regarded as an adequate method of birth
control; however, if the subject becomes sexually active during the study, she must
agree to use adequate birth control as defined above for the remainder of the study.
Male subjects must abstain from sex with WOCBP or use an adequate method of
contraception (as described above) from the time of informed consent through the end
of the study;
23. Have a known allergy and/or sensitivity to the test article or its components;
24. Have a condition or be in a situation which the Investigator feels may put the subject
at significant risk, may confound the study results, or may interfere significantly
with the subject's participation in the study;
25. Be currently enrolled in an investigational drug or device study or have used an
investigational drug or device within 30 days of Visit 1;
26. Have used any of the following treatments in the period indicated before Visit 1 or
anticipate their use at any time during the study: Day of Visit 1 1. All topical
ophthalmic preparations (e.g., over-the counter-solutions, artificial tears, gels,
scrubs, ointments) 7 days prior to Visit 1 2. Antihistamines (including topical
ophthalmic antihistamines) 3. Medications for glaucoma 30 days prior to Visit 1 4.
Topical ophthalmic non-steroidal anti-inflammatories 5. Topical ophthalmic
corticosteroids 6. Topical ophthalmic autologous serum 7. Topical ophthalmic
antibiotics 8. Mast cell stabilizers (Zaditor and Alamast ) 9. Oral aspirin or
aspirin-containing products except in the case that it was taken on a stable daily
dosing regimen for at least 30 days prior to Visit 1 and is expected to be taken on
the same regimen throughout the study period 10. Any other medication known to cause
ocular drying (e.g., anticholinergics, diuretics, antidepressants, beta blockers)
except in the case that it was taken on a stable daily dosing regimen for at least 30
days prior to Visit 1 and is expected to be taken on the same regimen throughout the
study period 12 weeks prior to Visit 1 11. Restasis 12. Xiidra 13. CEQUA™ 14. Eysuvis™
15. LipiFlow or other similar meibomian gland dysfunction (MGD) therapy 16. TrueTear
17. Corticosteroids (e.g., systemic steroids including intravenous, intramuscular,
intraarticular, and oral steroids; facial topical steroids; dermatological steroids
with high potency or large treatment areas); 18. Tetracyclines (tetracycline,
doxycycline, minocycline, etc.)
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