Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:05 AM
Ignite Modification Date:
2025-12-25 @ 1:05 AM
NCT ID:
NCT02815293
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02815293
Study Brief:
Protocol Section:
NCT02815293