| Eligibility |
Inclusion Criteria:
• Individuals eligible to participate in this study must meet all of the following
criteria: 0. Be at least 18 years of age;
1. Provide written informed consent;
2. Be willing and able to comply with all study procedures;
3. Have a patient-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 within 6 months
of Visit 1;
5. Have a best corrected visual acuity (BCVA) of 0.7 logarithm of the minimum angle of
resolution (logMAR) or better (Snellen equivalent score of 20/100 or better) in each
eye at Visit 1;
6. Have a score of = 2 for both eyes according to the Ora Calibra® Ocular Discomfort & 4-
Symptom Questionnaire in at least one of the dry eye symptoms at Visits 1 and 2;
7. Have an unanesthetized Schirmer's Test score of = 10 mm/5 minutes and = 1 mm/5 minutes
in at least one eye at Visits 1 and 2;
8. Have a corneal fluorescein staining score of = 2 according to the Ora Calibra® Corneal
and Conjunctival Staining Scale for Grading of Fluorescein Staining in at least one
region in one eye at Visits 1 and 2 and a central score = 1 in the same eye;
9. Have a conjunctival redness score = 1 according to the Ora Calibra® Conjunctival
Redness for Dry Eye Scale in at least one eye at Visits 1 and 2 pre-CAE®;
10. Demonstrate in the same eye(s) a response to the CAE® at Visits 1 and 2 as defined by:
- Having at least a =1 point increase in fluorescein staining in the inferior
region in at least one eye following CAE® exposure; a. 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). Note: a subject cannot have an Ocular
Discomfort score of 4 at time = 0);
11. Have at least one eye, the same eye, satisfy all criteria for 8, 9, 10 and 11 above;
12. A negative urine pregnancy test if female of childbearing potential (those who are not
surgically sterilized [bilateral tubal ligation, hysterectomy or bilateral
oophorectomy] or post-menopausal [12 months after last menses]) and must use adequate
birth control through the study period. For non-sexually active females, abstinence
may be regarded as an adequate method of birth control.)
Exclusion Criteria:
• Individuals who meet any of the following exclusion criteria will not be eligible to
participate in the study: 0. Have any clinically significant slit lamp findings at Visit 1
that may include active blepharitis, meibomian gland dysfunction, lid margin inflammation,
or active ocular allergies that require therapeutic treatment, and/or in the opinion of the
investigator may interfere with study parameters;
1. Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active
ocular inflammation at Visit 1;
2. Have worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses
during the study;
3. Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the
last 12 months;
4. Have used Restasis®, Xiidra®, or Cequa®, Eysuvis™ and Tyrvaya™ within 60 days of Visit
1;
5. Have had any ocular and/or lid surgeries in the past 6 months or have any planned
ocular and/or lid surgeries over the study period;
6. Be using or anticipate using temporary punctal plugs during the study that have not
been stable within 30 days of Visit 1;
7. Be currently taking any topical ophthalmic prescription (including medications for
glaucoma) or over-the-counter solutions, artificial tears, gels or scrubs, and cannot
discontinue these medications for the duration of the trial (excluding medications
allowed for the conduct of the study); the respective wash- out periods are required
for the following medications:
- Antihistamines (including ocular): 72 hours prior to Visit 1
1. Oral aspirin or aspirin-containing products allowed if dose has been stable
over past 30 days prior to Visit 1 and no change in dose is anticipated
during the study period
2. Corticosteroids or mast cell stabilizers (including ocular): 14 days prior
to Visit 1
3. Any medication (oral or topical) known to cause ocular drying that has not
been administered as a stable dose for at least 30 days prior to Visit 1 and
during the study
4. All other topical ophthalmic preparations (including artificial tear
substitutes) other than the study drops: 72 hours prior to Visit 1
8. Have an uncontrolled systemic disease;
9. Be a woman who is pregnant, nursing, or planning a pregnancy;
10. Be unwilling to submit a urine pregnancy test at Visit 1 and Visit 6 (or early
termination visit) if of childbearing potential. 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);
11. Be a woman of childbearing potential who is not using 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; intrauterine device; or 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;
12. Have a known allergy and/or sensitivity to the test article or its components;
13. 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;
14. Be currently enrolled in an investigational drug or device study or have used an
investigational drug or device within 30 days of Visit 1;
15. Be unable or unwilling to follow instructions, including participation in all study
assessments and visits.
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