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

Allergan

Status and phase

Terminated

Phase 3

Conditions

Dry Eye Syndromes

Treatments

Drug: AGN-195263

Drug: Vehicle

Study type

Interventional

Funder types

Industry

Identifiers

NCT02815293

195263-009

Details and patient eligibility

About

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

Enrollment

36 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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