Topical Ophthalmic AGN-195263 for the Treatment of Evaporative Dry Eye

Inclusion Criteria:

- Male, 18 years of age or older, at the screening (day -51) visit OR

- Females, who are naturally postmenopausal (permanent cessation of menstrual periods
for at least 12 consecutive months) or are permanently sterilized (ie, eg, tubal
occlusion, hysterectomy, bilateral salpingectomy, and/or bilateral oophorectomy) at
the screening (day -51) visit

- In at least 1 eye, all of the following objective measures of evaporative dry eye
(EDE) must be present at the standardization (day -21) and baseline (day 1) visits.
The same eye must qualify at both visits

- Tear film break-up time (TBUT) ≥ 2 seconds and ≤ 7 seconds

- Corneal sodium fluorescein staining score ≥ 1 and ≤ 4 (Oxford scheme)

- Anesthetized Schirmer's tear test score ≥ 10 mm after 5 minutes

- At the standardization (day -21) and baseline (day 1) visits, patients must have:

- Ocular Surface Disease Index© (OSDI) score > 12 (0 to 100 scale)

- Overall ocular discomfort score ≥ 1 and < 4 (0 to 4 scale; 0 = none, 4 = very
severe)

- Ocular burning score ≥ 1 and < 4 (0 to 4 scale; 0 = none, 4 = very severe)

- Blurred vision score ≥ 1 and < 4 (0 to 4 scale; 0 = none, 4 = very severe)

- In at least 1 eye, a lower lid margin meibum quality global assessment score ≥ 1 at
the standardization (day -21) and baseline (day 1) visits. The same eye must qualify
at both visits

- In at least 1 eye, the number of lower lid margin expressible meibomian glands must be
≥ 3 at the standardization (day -21) and baseline (day 1) visits. The same eye must
qualify at both visits

- Use of an artificial tear product or lid hygiene (ie, warm compress, lid massage, lid
scrub) for the treatment of dry eye disease, EDE or meibomian gland disease within 1
year of the standardization (day -21) visit

Exclusion Criteria:

- Male patients with a history of, known, or suspected prostate cancer

- Male patients with a prostate-specific antigen (PSA) level ≥ 4 μg/L

- Female patients with a history of known or suspected breast, cervical, ovarian, or
uterine cancer

- Female patient who is of child-bearing potential

- At standardization (day -21) and / or baseline (day 1) visits, a lower lid margin
meibum quality global assessment score of non-expressible (NE) in either eye

- Patients who are currently or have used hormone replacement therapy or estrogen and
/or progesterone based products (including herbal and nutritional supplements) within
90 days of the standardization (day -21) visit or anticipated use during the study

- Patients who are currently using or have used any androgen or anti-androgen treatment
(including herbal and nutritional supplements), within 90 days of the standardization
(day -21) visit or anticipated use during the study

- Patients who are currently using or have used any hair growth product within 90 days
of the standardization (day -21) visit or anticipated use during the study

- Patients who are currently using or have used corticosteroids administered via any
route within 30 days prior to the standardization (day -21) visit, or any anticipated
use via any route of administration prior to the month 6 visit

- Patients who are currently using or have used oral or topical macrolides,
tetracycline, tetracycline derivative drugs (including doxycycline and minocycline),
retinoids (eg, isotretinoin), or calcineurin inhibitors (ie, RESTASIS®, Ikervis®)
within 60 days of the standardization (day -21) visit, or anticipated use prior to the
month 6 visit