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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02965846
• Date of registration: 15/11/2016
• Prospective Registration: Yes
• Primary sponsor: Allergan
• Public title: Topical Ophthalmic AGN-195263 for the Treatment of Evaporative Dry Eye
• Scientific title: Topical Ophthalmic AGN-195263 for the Treatment of Evaporative Dry Eye
• Date of first enrolment: December 13, 2016
• Target sample size: 43
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02965846
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 3

Countries of recruitment

Czech Republic, Czechia, France, Germany, Hungary, Italy, Philippines, Poland, Spain, Taiwan, Turkey, United Kingdom, United States

Contacts

• Name: Khristopher Hansen
• Affiliation: Allergan

Key inclusion & exclusion 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, 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Dry Eye Syndromes

Intervention(s)

Drug: AGN-195263

Drug: Vehicle

Primary Outcome(s)

Overall Ocular Discomfort Score (0 to 4 Scale; 0=None, 4=Very Severe) [Time Frame: 6 month visit]

Secondary Outcome(s)

Change From Baseline in Tearfilm Break Up Time (TBUT) [Time Frame: Baseline (day 1) to 6 month visit]

Secondary ID(s)

195263-010

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 30/11/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02965846