NCT04675151已完成2 期
Safety and Efficacy of Nyxol (0.75% Phentolamine Ophthalmic Solution) With Pilocarpine Eye Drops in Subjects With Presbyopia
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 17
- 主要终点
- Percent of Subjects With ≥ 15 Letters of Improvement in Photopic Binocular DCNVA
研究概览
简要总结
The objectives of this study are:
To evaluate the efficacy of Nyxol + Pilocarpine to improve DCNVA in subjects with presbyopia
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females ≥ 40 and ≤ 64years of age.
- •BCDVA of 0.0 LogMAR(20/20 Snellen equivalent) or better in each eye under photopic conditions.
- •DCNVA of 0.4 LogMAR (20/50 Snellen equivalent) or worse under photopic conditions in each eye and binocularly.
- •Subjects who depend on reading glasses or bifocals in which their binocular best-corrected near VA is 0.1 LogMAR (20/25 Snellen equivalent) or better.
排除标准
- •Ophthalmic (in either eye):
- •Use of any topical prescription or OTC ophthalmic medications of any kind within 7 days of Screening until study completion.
- •Use of any over-the-counter (OTC) artificial tears (preserved or unpreserved) at least once per day within 7 days of Screening until study completion.
- •Current use of any topical ophthalmic therapy for dry eye.
- •Tear break-up time of < 5 seconds or corneal fluorescein staining.
- •Clinically significant ocular disease that might interfere with the study as deemed by the Investigator.
- •Recent or current evidence of ocular infection or inflammation in either eye.
- •Any history of herpes simplex or herpes zoster keratitis.
- •History of diabetic retinopathy or diabetic macular edema.
- •Known allergy, hypersensitivity, or contraindication to any component of the phentolamine, pilocarpine, or vehicle formulations.
- •History of cauterization of the punctum or punctal plug (silicone or collagen) insertion or removal.
- •Ocular trauma, ocular surgery, ocular laser treatment within the 6 months prior to Screening. Any subject with multifocal intraocular lenses are excluded.
- •History of any traumatic (surgical or nonsurgical) or non traumatic condition affecting the pupil or iris.
- •Unwilling or unable to discontinue use of contact lenses.
- •Conjunctival hyperemia ≥ grade 2 on the CCLRU 4-point scale.
- •Known hypersensitivity or contraindication to alpha- and/or beta adrenoceptor antagonists.
- •Known hypersensitivity or contraindication to any systemic cholinergic parasympathomimetic agents.
- •Clinically significant systemic disease that might interfere with the study as deemed by the Investigator.
- •Participation in any investigational study within 30 days prior to Screening.
- •Females of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control.
- •Resting HR outside the specified range of 50 to 110 beats per minute.
- •Hypertension with resting diastolic BP > 105 mmHg or systolic BP > 160 mmHg.
研究组 & 干预措施
Nyxol + Pilocarpine
Experimental
1 drop of Nyxol (Treatment 1) and 1 drop of Pilocarpine (Treatment 2)
干预措施: Phentolamine Ophthalmic Solution 0.75% (Drug)
Nyxol + Pilocarpine
Experimental
1 drop of Nyxol (Treatment 1) and 1 drop of Pilocarpine (Treatment 2)
干预措施: Pilocarpine (Drug)
Nyxol
Active Comparator
1 drop of Nyxol (Treatment 1)
干预措施: Phentolamine Ophthalmic Solution 0.75% (Drug)
Pilocarpine
Active Comparator
1 drop of Pilocarpine (Treatment 2)
干预措施: Pilocarpine (Drug)
Pilocarpine
Active Comparator
1 drop of Pilocarpine (Treatment 2)
干预措施: Placebo (Other)
Placebo
Placebo Comparator
1 drop of Placebo (Treatment 1)
干预措施: Placebo (Other)
结局指标
主要结局
Percent of Subjects With ≥ 15 Letters of Improvement in Photopic Binocular DCNVA
时间窗: Visit 2 at 1 hour
The primary efficacy endpoint was the percent of subjects with ≥ 15 letters of improvement in photopic binocular DCNVA on Visit 2 at 1 hour with POS + LDP compared to placebo alone. The improvement in binocular DCNVA for each subject was relative to the subject's own baseline value (Visit 1).
次要结局
- Percentage of Subjects With Improvement of ≥ 5, ≥ 10, and ≥ 15 Letters in DCNVA (Photopic) From Baseline(Visit 2 at 0.5 hours, at 2 hours, at 3 hours, at 4 hours, and at 6 hours)
- Percentage of Subjects With Improvement of ≥ 15 Letters in DCNVA (Photopic) at 1 Hour and With < 5 Letters of Loss in Photopic Binocular BCDVA From Baseline(Visit 2 at 1 hour)
- Percentage of Subjects With Improvement in DCIVA (Photopic) From Baseline(Visit 2 at 1 hour, at 3 hours, and at 6 hours)
研究者
研究点 (17)
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