topical ophthalmic agn-195263 for the treatment of evaporative dry eye

Conditions: Dry Eye Syndromes

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

Keywords: ede evaporative dry eye