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