Randomized, Double-Masked, Placebo-Controlled, Multicenter, Phase 3 Study of the Safety and Efficacy of Nyxol (Phentolamine Ophthalmic Solution 0.75%) as a Single Agent and With Adjunctive Low-Dose Pilocarpine Hydrochloride Ophthalmic Solution 0.4% in Subjects With Presbyopia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 333
- 试验地点
- 51
- 主要终点
- Percent of Subjects With ≥ 15 Letters of Improvement in Photopic Binocular DCNVA and With < 5 Letters of Loss in Photopic Binocular BCDVA in Nyxol-treated Subjects
研究概览
简要总结
The objectives of this study are:
To evaluate the safety and efficacy of Nyxol alone and with adjunctive low dose pilocarpine to improve distance-corrected near visual acuity (DCNVA) in subjects with presbyopia.
详细描述
This is a Randomized, Double-Masked, Placebo-Controlled, Multicenter, Phase 3 Study of the Safety and Efficacy of Nyxol (Phentolamine Ophthalmic Solution 0.75%) as a Single Agent and With Adjunctive Low-Dose Pilocarpine Hydrochloride Ophthalmic Solution 0.4% 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 ≤ 64 years of age.
- •BCDVA of 0.1 LogMAR (20/25 Snellen equivalent) or better in each eye in photopic conditions.
- •DCNVA of 0.4 LogMAR (20/50 Snellen equivalent) or worse but not > 0.7 LogMAR (20/100 Snellen equivalent) in photopic conditions in each eye and binocularly.
- •For subjects who depend on reading glasses or bifocals, binocular best-corrected near VA is 0.1 LogMAR (20/25 Snellen equivalent) or better.
- •Photopic PD of ≥ 3 mm in either eye.
排除标准
- •Ophthalmic (in either eye):
- •Use of any topical prescription or over-the-counter (OTC) ophthalmic medications of any kind within 7 days of Screening until study completion, with the exception of lid scrubs with OTC products and artificial tears as specified in Exclusion # 2 below.
- •Use of any OTC artificial tears (preserved or unpreserved) during Visit days or 15 min before or after instillation of study medication.
- •Current use of any topical ophthalmic therapy for dry eye.
- •Tear break-up time of < 5 seconds or corneal fluorescein staining Grade ≥ 2 in the inferior zone or Grade ≥ 1 in the central zone using the National Eye Institute scale..
- •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.
- •Known allergy, hypersensitivity, or contraindication to any component of the phentolamine, pilocarpine, or vehicle formulations.
- •Prior participation in a study involving the use of Nyxol for the treatment of presbyopia.
- •History of cauterization of the punctum or punctal plug (silicone or collagen) insertion or removal.
- •Ocular trauma within 6 months prior to Screening.
- •Ocular surgery or any ocular laser treatment within 6 months prior to Screening.
- •Subjects with surgical monovision, multifocal or extended depth of focus intraocular lenses (IOLs) are excluded.
- •History of any traumatic (surgical or nonsurgical) or nontraumatic condition affecting the pupil or iris.
- •Contact lens wear on the day of any study visit and contact lenses must be removed for home dosing and for at least 10 minutes following dosing.
- •Known hypersensitivity or contraindication to alpha- and/or beta-adrenoceptor antagonists .
- •Known hypersensitivity or contraindication to any systemic cholinergic parasympathomimetic agent.
- •Clinically significant systemic disease that might interfere with the study as deemed by the judgment of the Investigator.
- •Initiation of treatment with, or any changes to, the current dosage, drug, or regimen of any systemic adrenergic or cholinergic drugs within 7 days prior to Screening or during the study.
- •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 range of 50 to 110 beats per min.
- •Hypertension with resting diastolic BP > 105 mmHg or systolic BP > 160 mmHg.
研究组 & 干预措施
Nyxol placebo
Nyxol placebo
干预措施: Placebo (Other)
Nyxol + low dose pilocarpine vehicle
Nyxol (phentolamine ophthalmic solution) 0.75% Pilocarpine vehicle
干预措施: Low dose pilocarpine vehicle (Other)
Placebo + low dose pilocarpine
Placebo Pilocarpine (0.4%)
干预措施: Placebo (Other)
Placebo + low dose pilocarpine vehicle
Placebo Pilocarpine vehicle
干预措施: Placebo (Other)
Placebo + low dose pilocarpine vehicle
Placebo Pilocarpine vehicle
干预措施: Low dose pilocarpine vehicle (Other)
Nyxol
Nyxol (phentolamine ophthalmic solution) 0.75%
干预措施: Phentolamine Opthalmic Solution 0.75% (Drug)
Placebo + low dose pilocarpine
Placebo Pilocarpine (0.4%)
干预措施: Low dose pilocarpine (Drug)
Nyxol + low dose pilocarpine
Nyxol (phentolamine ophthalmic solution) 0.75% Pilocarpine (0.4%)
干预措施: Phentolamine Opthalmic Solution 0.75% (Drug)
Nyxol + low dose pilocarpine vehicle
Nyxol (phentolamine ophthalmic solution) 0.75% Pilocarpine vehicle
干预措施: Phentolamine Opthalmic Solution 0.75% (Drug)
Nyxol + low dose pilocarpine
Nyxol (phentolamine ophthalmic solution) 0.75% Pilocarpine (0.4%)
干预措施: Low dose pilocarpine (Drug)
结局指标
主要结局
Percent of Subjects With ≥ 15 Letters of Improvement in Photopic Binocular DCNVA and With < 5 Letters of Loss in Photopic Binocular BCDVA in Nyxol-treated Subjects
时间窗: Baseline at 30 min post-LDP/vehicle comparing subjects treated with Nyxol + LDP to subjects treated with placebo + LDP vehicle at Visit 5 (Stage 2 Day 8)
The primary efficacy endpoint is the percent of subjects with ≥ 15 letters of improvement in photopic binocular DCNVA and with \< 5 letters of loss in photopic binocular BCDVA from Baseline at 30 min post-LDP/vehicle comparing subjects treated with Nyxol + LDP to subjects treated with placebo + LDP vehicle at Visit 5 (Stage 2 Day 8).
次要结局
未报告次要终点