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

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

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

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, lid hygiene (ie, warm compress, lid massage, lid scrub), omega-3 supplementation (topical ocular or systemic), or antibiotics (ie, systemic or topical macrolides, tetracyclines, tetracycline derivatives [including doxycycline and minocycline]) for the treatment of dry eye disease, 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 using estrogen and/or progesterone containing products (including herbal and nutritional supplements) and not on a stable dose (at least 90 days prior to the standardization visit (day -21) and/or anticipate initiating use and/or changing 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 topical corticosteroids in the eyes or on the eyelids within 60 days prior to the standardization visit (day -21), or any such use anticipated prior to the month 6 visit
• Patients who are currently using or have used oral or topical macrolides, tetracyclines, tetracycline derivative drugs (including doxycycline and minocycline), retinoids (eg, isotretinoin), calcineurin inhibitors (ie, RESTASIS®, Ikervis®), oral (systemic) corticosteroids, or lifitegrast (Xiidra™) or any other therapeutic dry eye treatment within 60 days of the standardization visit (day -21), or anticipated use before the month 6 visit