Topical Ophthalmic AGN-195263 for the Treatment of Evaporative Dry Eye
Status: | Terminated |
---|---|
Conditions: | Ocular |
Therapuetic Areas: | Ophthalmology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 2/21/2019 |
Start Date: | September 30, 2016 |
End Date: | June 21, 2017 |
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
- 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 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
We found this trial at
29
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University Hospitals of Cleveland The history of University Hospitals Case Medical Center is linked to...
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12665 Garden Grove Boulevard
Garden Grove, California 92843
Garden Grove, California 92843
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1506 East Griffin Parkway
Mission, Texas 78572
Mission, Texas 78572
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