NCT02965846终止3 期
Topical Ophthalmic AGN-195263 for the Treatment of Evaporative Dry Eye
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Allergan
- 入组人数
- 43
- 试验地点
- 49
- 主要终点
- Overall Ocular Discomfort Score (0 to 4 Scale; 0=None, 4=Very Severe)
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
AGN-195263
Experimental
干预措施: AGN-195263 (Drug)
Vehicle
Placebo Comparator
干预措施: Vehicle (Drug)
结局指标
主要结局
Overall Ocular Discomfort Score (0 to 4 Scale; 0=None, 4=Very Severe)
时间窗: 6 month visit
The overall ocular discomfort will be assessed on a questionnaire using a 0 to 4 scale on which 0=none, 1=mild, 2=moderate, 3=severe and 4=very severe.
次要结局
- Change From Baseline in Tearfilm Break Up Time (TBUT)(Baseline (day 1) to 6 month visit)
研究者
研究点 (49)
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