| Eligibility |
Inclusion Criteria:
1. Be at least 18 years of age;
2. Provide written informed consent;
3. Be willing and able to comply with all study procedures;
4. Have a patient-reported history of dry eye for at least 6 months prior to Visit 1;
5. Have a history of use or desire to use eye drops for dry eye symptoms within 6 months
of Visit 1;
6. 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;
7. Report a score of = 2 according to the Ora Calibra® Ocular Discomfort & 4-Symptom
Questionnaire in at least one of the dry eye symptoms at Visits 1 and 2;
8. Have a Schirmer's Test score of = 10 mm and = 1 mm at Visits 1 and 2;
9. Have a corneal fluorescein staining score of = 2 in at least one region 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;
10. Have a total lissamine green conjunctival score of = 2, based on the sum of the
temporal and nasal regions pre-CAE® at Visits 1 and 2;
11. 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;
12. Demonstrate in the same eye(s) 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;
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). Note: a subject cannot have
an Ocular Discomfort score of 4 at time = 0);
13. Have at least one eye, the same eye, satisfy all criteria for 8, 9, 10, 11 and 12
above;
14. 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:
1. Have any clinically significant slit lamp findings at Visit 1 that may include active
blepharitis, meibomian gland dysfunction, ocular rosacea, lid margin inflammation, or
active ocular allergies that require therapeutic treatment, or currently using
tetracyclines (e.g., doxycycline, minocycline, tetracycline) and/or in the opinion of
the investigator may interfere with study parameters;
2. Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active
ocular inflammation at Visit 1;
3. Have worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses
during the study;
4. Have previously had laser-assisted in situ keratomileusis (LASIK) surgery,
Photorefractive keratectomy (PRK), or small incision lenticule extraction (SMILE)
within the last 12 months;
5. Have used Restasis®, Xiidra®, Cequa®, Tyrvaya®, serum tears, generic cyclosporine A,
and EYSUVIS® within 30 days of Visit 1;
6. 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;
7. Any use of Lipiflow, thermopulsation, Meibomian gland expression or intense pulsed
light treatment within 6 months of visit 1
8. Be using or anticipate using temporary punctal plugs during the study that have not
been stable within 30 days of Visit 1 or have permanent punctal plugs or had surgical
punctal occlusion;
9. 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:
1. Antihistamines (including ocular): 72 hours prior to Visit 1
2. 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
3. Corticosteroids or mast cell stabilizers (including ocular): 14 days prior to
Visit 1
4. 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
5. Neurostimulators: 30 days prior to Visit 1
6. Current use or planned use of Prokera® during study conduct or within 30 days
prior to Visit 1
7. All other topical ophthalmic preparations (including artificial tear substitutes)
other than the study drops: 72 hours prior to Visit 1
10. Have an uncontrolled systemic disease;
11. Be a woman who is pregnant, nursing, or planning a pregnancy;
12. 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 postmenopausal (without menses for 12 consecutive months);
13. 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;
14. Have a known allergy and/or sensitivity to the test article or its components;
15. 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;
16. Be currently enrolled in an investigational drug or device study or have used an
investigational drug or device within 30 days of Visit 1;
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