Topical Ophthalmic AGN-195263 for the Treatment of Evaporative Dry Eye
Condition: Dry Eye Syndromes
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca
Intervention: AGN-195263; Vehicle
Intervention description: 1 drop of AGN-195263 will be instilled in each eye twice daily.; 1 drop of AGN-195263 vehicle (placebo) will be instilled in each eye twice daily.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: EDE; evaporative dry eye

Summary:

      The objectives of this study are twofold

        -  To evaluate the safety and efficacy of 0.1% AGN-195263 administered twice daily compared
           to its vehicle in patients with evaporative dry eye (EDE)

        -  To evaluate the systemic pharmacokinetics of 0.1% AGN-195263 administered twice daily in
           patients with EDE
    

Eligibility criteria:

        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