NCT06542497已完成3 期
Randomized, Double-masked, Placebo-controlled, Multicenter Study of the Efficacy and Safety of Phentolamine Ophthalmic Solution (POS) 0.75% in Participants With Presbyopia
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 569
- 试验地点
- 39
- 主要终点
- Primary efficacy endpoint
研究概览
简要总结
Safety and efficacy of POS in participants with presbyopia
详细描述
Randomized, Double-Masked, Placebo-Controlled, Multicenter, Phase 3 Study of the Efficacy and Safety of Phentolamine Ophthalmic Solution (POS) 0.75% in Participants 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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Double-masked, placebo-controlled
入排标准
- 年龄范围
- 45 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants must meet all of the following criteria:
- •Males or females ≥ 45 and ≤ 64 years of age
- •Able to comply with all protocol-mandated procedures independently and to attend all scheduled office visits
- •Able and willing to give signed informed consent
- •Able to self-administer study medication throughout the study period
- •Inclusion criteria #5, #6, and #7 must all be met at both Screening and Baseline Visits:
- •BCDVA of 55 Early Treatment Diabetic Retinopathy Study (ETDRS) letters (20/20 Snellen equivalent) or better in photopic conditions in each eye
- •DCNVA of 50 ETDRS letters (20/50 Snellen equivalent) or worse but not <35 ETDRS letters (20/100 Snellen equivalent) in photopic conditions in each eye and binocularly
- •For participants who depend on reading glasses or bifocals, binocular best-corrected near VA of 65 ETDRS letters (20/25 Snellen equivalent) or better
- •Photopic PD of ≥ 4 mm in the study eye at Screening
排除标准
- •Excluded from the study will be individuals with any of the following characteristics:
- •Ophthalmic (in either eye):
- •Use of any topical prescription (including Vuity® or Qlosi™) 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 (eg, OCuSOFT® lid scrub, SteriLid®, baby shampoo, etc.) and artificial tears as specified in Exclusion Criterion #2 below
- •Use of any OTC artificial tears (preserved or unpreserved) during visit days or 15 min before or after instillation of study medication
- •Use of Ryzumvi™ (POS) within 7 days prior to Screening
- •Use of any dry eye product, such as topical ophthalmic therapy for dry eye (eg, generic cyclosporine, Restasis®, Xiidra®, Cequa®, Eysuvis®, and Meibo®) or intranasal dry eye product (eg, Tyrvaya®) or other devices within 12 months prior to Screening
- •Tear break-up time of < 5 seconds or corneal fluorescein staining (CFS) Grade ≥ 2 in the inferior zone or Grade ≥ 1 in the central zone using the National Eye Institute scale
- •Clinically significant ocular disease (eg, cataract, glaucoma, corneal edema, uveitis, retinal degeneration, loss of visual field, or any macular pathology) that, in the judgment of the Investigator, might interfere with study procedures
- •Recent or current evidence of ocular infection or inflammation in either eye (such as current evidence of clinically significant blepharitis, conjunctivitis, keratitis, etc.). Participants must be symptom free for at least 7 days prior to Screening
- •Any history of herpes simplex or herpes zoster keratitis
- •Known allergy, hypersensitivity, or contraindication to any component of the phentolamine or vehicle formulations
- •Prior participation in a study involving the use of POS for the treatment of presbyopia or night vision disturbance
- •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. Any history of radial keratotomy is prohibited
- •Participants with surgical monovision, multifocal, or extended depth-of-focus intraocular lenses (IOLs). Monofocal IOLs are acceptable if in place > 6 months prior to Screening
- •Monofocal IOL in place > 6 months prior to Screening with any posterior capsule opacification
- •History of any traumatic (surgical or nonsurgical) or nontraumatic condition affecting the pupil or iris (eg, irregularly shaped pupil, neurogenic pupil disorder, iris atrophy, iridotomy, iridectomy, iritis, etc.)
- •Unwilling or unable to discontinue use of contact lenses at least 1 hour prior to Screening for soft contact lenses or at least 8 hours prior to Screening for hard gas permeable contact lenses, and at least 8 hours (for both types of lenses) prior to all other office visits
- •Known hypersensitivity or contraindication to alpha- and/or beta-adrenoceptor antagonists (eg, chronic obstructive pulmonary disease or bronchial asthma; abnormally low blood pressure (BP) or heart rate (HR); second- or third-degree heart blockage or congestive heart failure)
- •Known hypersensitivity or contraindication to any systemic cholinergic parasympathomimetic agent
- •Clinically significant systemic disease (eg, uncontrolled diabetes, myasthenia gravis, cancer, hepatic, renal, endocrine, or cardiovascular disorders) 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; however, Flomax® (tamsulosin) is specifically excluded
- •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. Acceptable methods include the use of at least one of the following: intrauterine device, hormonal contraception (oral, injection, patch, implant, ring), barrier with spermicide (condom, diaphragm), or abstinence. A female is considered to be of childbearing potential unless she is 1 year postmenopausal or 3 months post-surgical sterilization. All females of childbearing potential, including those with post-tubal ligation, must have a negative urine pregnancy test result at Visit 1 (Screening)
- •Resting HR outside the range of 50 to 110 beats per min (bpm) following at least a 5 min rest period in the sitting position at Visit 1 (Screening). HR may be repeated only once if outside the specified range, following another 5 min rest period in the sitting position
- •Hypertension with resting diastolic BP > 105 mmHg or systolic BP > 160 mmHg following at least a 5-min rest period in the sitting position at Visit 1 (Screening). BP may be repeated only once if outside the specified range, following another 5-min rest period in the sitting position
研究组 & 干预措施
phentolamine ophthalmic solution vehicle
Placebo Comparator
Drug: Placebo
干预措施: Placebo (Drug)
0.75% phentolamine ophthalmic solution
Active Comparator
Drug: phentolamine ophthalmic solution 0.75%, a non-selective alpha-1 and alpha-2 adrenergic antagonist
干预措施: 0.75% phentolamine ophthalmic solution (Drug)
结局指标
主要结局
Primary efficacy endpoint
时间窗: Day 8
The primary efficacy endpoint is the percentage of participants with ≥ 15 letters of improvement in binocular DCNVA and with \< 5 letters of loss in binocular BCDVA from baseline comparing POS-treated participants to placebo-treated participants at 12 hours post-dose at Visit 4 (Day 8)
Percentage of Subjects With ≥ 15 Letters of Improvement in Binocular DCNVA and With < 5 Letters of Loss in Binocular BCDVA From Baseline Comparing POS-treated Participants to Placebo-treated Participants at 12 Hours Post-dose at Visit 4 (Day 8)
时间窗: 8 Days
The primary efficacy endpoint is the percentage of participants with ≥ 15 letters of improvement in binocular DCNVA and with \< 5 letters of loss in binocular BCDVA from baseline comparing POS-treated participants to placebo-treated participants at 12 hours post-dose at Visit 4 (Day 8).
次要结局
- Percentage of Subjects With ≥ 15 Letters of Improvement in Binocular DCNVA and With < 5 Letters of Loss in Binocular BCDVA From Baseline at Day 1 (1-hour Post-dose), Day 3, and Week 6(6 Weeks)
- Percentage of Subjects With ≥ 5, ≥ 10, and ≥ 15 Letters of Improvement in DCNVA From Baseline (Binocular) at Day 1 (0.5 Hours and 1 Hour Post-dose), Day 3, Day 8, and Week 6(6 Weeks)
- Percentage of Subjects With ≥ 5, ≥ 10, and ≥ 15 Letters of Improvement in DCNVA From Baseline (Monocular - Study Eye) at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6(6 Weeks)
- Change in DCNVA From Baseline (Binocular) at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6(6 Weeks)
- Change in DCNVA From Baseline (Monocular - Study Eye) at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6(6 Weeks)
- Change in Mean Binocular DCNVA From Baseline at Week 6 Compared to the Best Prior Observed Change From Baseline in Mean Binocular DCNVA in Subjects Treated With POS(6 Weeks)
- Percentage of Subjects With DCNVA ≤ 20/15, ≤ 20/20, ≤ 20/25, ≤ 20/32, ≤ 20/40, ≤ 20/50, ≤ 20/63, ≤ 20/80, ≤ 20/100, ≤ 20/125, and ≤ 20/160 at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6(6 Weeks)
- Percentage of Subjects With Baseline DCNVA ≤ 20/63, ≤ 20/80, ≤ 20/100, ≤ 20/125, and ≤ 20/160 With a ≥ 10-Letter and ≥ 15-Letter Improvement in DCNVA at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6(6 Weeks)
- Percentage of Subjects With ≥ 5, ≥ 10, and ≥ 15 Letters of Improvement in Binocular DCIVA From Baseline at Day 1 (1-hour Post-dose), Day 3, Day 8, and Week 6(6 Weeks)
- Change in Binocular DCIVA From Baseline at Day 1 (1-hour Post-dose), Day 3, Day 8, and Week 6(6 Weeks)
- Percentage of Subjects With Loss or Improvement in BCDVA From Baseline (Binocular) at Day 1 (1-hour Post-dose), Day 3, Day 8, and Week 6(6 Weeks)
- Change in BCDVA From Baseline (Binocular) at Day 1 (1-hour Post-dose), Day 3, Day 8, and Week 6(6 Weeks)
- Change in BCDVA From Baseline (Monocular - Study Eye) at Day 1 (1-hour Post-dose), Day 3, Day 8, and Week 6(6 Weeks)
- Change in Pupil Diameter From Baseline at Day 3 and Day 8(8 Days)
- Percent Change in Pupil Diameter From Baseline at Day 3 & Day 8(8 Days)
- Percentage of Subjects With Pupil Diameter of < 3.5, < 3.0, < 2.5, < 2.0, and < 1.5 mm at Day 3 and Day 8(8 Days)
- Percentage of Subjects With Pupil Diameter of 1.5 to < 2.0 mm, 2.0 to < 2.5 mm, 2.5 to < 3.0 mm, and 3.0 to < 3.5 mm at Day 3 and Day 8(8 Days)
- Change From Baseline in Overall and Component Subject-Reported Outcomes at Day 3, Day 8, and Week 6(6 Weeks)
研究者
研究点 (39)
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相关资讯
Ocuphire Pharma Initiates Phase 3 Trial of Phentolamine Ophthalmic Solution for Presbyopia- Ocuphire Pharma has dosed the first patient in its Phase 3 VEGA-3 clinical trial evaluating phentolamine ophthalmic solution 0.75% for presbyopia.
- Phentolamine ophthalmic solution 0.75% is under development as a non-invasive alternative to traditional presbyopia treatments.
- The VEGA-3 trial (NCT06542497) aims to assess the efficacy and safety of this novel ophthalmic solution.2 years agoOcuphire Pharma Initiates Phase 3 VEGA-3 Trial of Phentolamine Ophthalmic Solution for Presbyopia- Ocuphire Pharma has dosed the first patient in its Phase 3 VEGA-3 clinical trial evaluating phentolamine ophthalmic solution 0.75% for presbyopia.
- The VEGA-3 trial is a randomized, double-masked, placebo-controlled study involving 545 participants, with top-line data expected in 2025.
- Phentolamine ophthalmic solution 0.75% aims to provide a non-invasive alternative to traditional corrective measures for presbyopia.
- Ocuphire anticipates using VEGA-3 data to support a supplemental New Drug Application with the FDA.2 years ago