NCT07140783招募中3 期
RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-MASKED STUDY OF THE SAFETY AND EFFICACY OF POS (0.75% PHENTOLAMINE OPHTHALMIC SOLUTION) IN PARTICIPANTS WITH PREVIOUS KERATOREFRACTIVE SURGERY WITH DECREASED VISUAL ACUITY UNDER MESOPIC CONDITIONS
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 580
- 试验地点
- 66
- 主要终点
- Percent of participants with >= 15 ETDRS letters (>= 3 lines) improvement in the study eye in mLCVA compared to Baseline (Day1 pre-dose) at Day 15
研究概览
简要总结
The goal of this clinical trial is to learn if Phentolamine Ophthalmic Solution works to treat adults that have had keratorefractive surgery and have decreased visual acuity under mesopic conditions. It will also learn about the safety of Phentolamine Ophthalmic Solution. The main questions it aims to answer are:
Researchers will compare Phentolamine Ophthalmic Solution to a placebo (a look-alike substance that contains no drug) to see if Phentolamine Ophthalmic Solution works to improve vision in low light conditions.
Participants will:
Take Phentolamine Ophthalmic Solution or a placebo drop every day for 2 weeks Visit the clinic once every week for 2 weeks for checkups and tests Keep a diary of when they instill the study medication each evening
详细描述
OPI-NXYDLD-303 RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-MASKED STUDY OF THE SAFETY AND EFFICACY OF POS (0.75% PHENTOLAMINE OPHTHALMIC SOLUTION) IN PARTICIPANTS WHO HAVE PREVIOUSLY HAD KERATOREFRACTIVE SURGERY AND HAVE DECREASED VISUAL ACUITY UNDER MESOPIC CONDITIONS
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)
盲法说明
Double masked
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
- •Males or females ≥ 18 years of age
- •Able to independently comply with all protocol-mandated procedures and to attend all scheduled office visits
- •Able and willing to give written consent to participate in this study
- •Able to self-administer study medication
- •Inclusion criteria #5, #6, #7, and #8 must all be met in the same eye:
- •History of keratorefractive surgery (eg, PRK, LASIK, SMILE, and RK/astigmatic keratotomy [AK]/limbal-relaxing incisions [LRI]) prior to 2010 in at least 1 eye and have participant reported night vision disturbances (eg, glare, halos, and/or starbursts). Symptoms must have been first noted within 2 months following keratorefractive surgery.
- •This test may be repeated once, following an additional 5 min of dark adaptation to the mesopic light conditions if the initial results do not meet this criterion
- •mLCVA ≤ 30 Early Treatment Diabetic Retinopathy Study (ETDRS) letters (20/63 Snellen or worse) in at least 1 eye using the Precision Vision Illuminator Cabinet with 5% translucent contrast chart and a mesopic filter at 4 m
- •≥ 10 ETDRS letters improvement in mLCVA in at least 1 eye during illumination of the contralateral eye with a Brightness Acuity Tester (BAT) system on the low setting using the Precision Vision Illuminator Cabinet with 5% translucent contrast chart and a mesopic filter at 4 m
排除标准
- •Ophthalmic (in either eye unless otherwise noted):
- •Prior unresolved dry eye diagnosis, taking prescription medication for dry eye (eg, drops, nasal sprays [Tyrvaya®], etc.), or taking artificial tear drops routinely for dry eye
- •Prior history of fluctuating vision
- •Clinically significant ocular disease as deemed by the Investigator (eg, untreated visually significant cataract, glaucoma, corneal edema, uveitis, severe keratoconjunctivitis sicca, retina degeneration, loss of visual field due to glaucoma or stroke, branch retinal vein occlusion, retina flare) that might interfere with the study
- •History or presence of corneal endothelial dystrophy (eg, Fuchs' dystrophy or presence of guttae)
- •Known hypersensitivity to any topical alpha-adrenoceptor antagonists
- •Known allergy or contraindication to any component of the vehicle formulation
- •History of cauterization of the punctum or punctal plug (silicone or collagen) insertion or removal in the study eye
- •Pseudophakic participants with extended depth-of-focus or multifocal intraocular lenses (IOLs)
- •Ocular trauma, ocular surgery (eg, IOLs), or laser procedure (eg, LASIK, PRK, SMILE, and RK/AK/LRI) within 6 months prior to Screening
- •Use of any topical prescription or over-the-counter (OTC) ophthalmic medications of any kind (including artificial tear drops) within 7 days prior to Screening until study completion, with the exception of lid scrubs with OTC products (eg, OCuSOFT® lid scrub, SteriLid®, baby shampoo, etc.)
- •Recent or current evidence of ocular infection or inflammation (such as current evidence of clinically significant blepharitis, conjunctivitis, or a history of herpes simplex keratitis or herpes zoster keratitis at Screening). Participants must be symptom free for at least 7 days prior to Screening
- •History of diabetic retinopathy, diabetic macular edema, or dry or wet macular degeneration in the study eye
- •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, 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
- •Previously undiagnosed dry eye, at the determination of the Investigator. Dry eye diagnosis should be based on one of the following dry eye test results: tear break-up time < 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
- •Known hypersensitivity or contraindication to alpha- and/or beta-adrenoceptor antagonists
- •Clinically significant systemic disease (eg, severe diabetes, myasthenia gravis, cancer, hepatic, renal, endocrine, or cardiovascular disorders) that might interfere with the study
- •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 or during the study
- •Participation in any other investigational study using POS
- •Females of childbearing potential who are pregnant, nursing, planning a pregnancy during the study, 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 < 3 months post-tubal ligation, must have a negative urine pregnancy test result at Screening to enroll in the study
- •Resting HR outside 50 to 110 beats per min at Screening. HR may be repeated only once if outside the specified range, following at least a 5-min rest period in the sitting position
- •Hypertension with resting diastolic BP > 105 mmHg or systolic BP > 160 mmHg at Screening. BP may be repeated only once if outside the specified range, following at least a 5-min rest period in the sitting position
研究组 & 干预措施
Placebo - Phentolamine Ophthalmic Solution vehicle
Placebo Comparator
Placebo-phentolamine ophthalmic solution vehicle
干预措施: Placebo (Drug)
0.75% Phentolamine Ophthalmic Solution
Experimental
0.75% Phentolamine Ophthalmic Solution
干预措施: 0.75% Phentolamine Ophthalmic Solution (Drug)
结局指标
主要结局
Percent of participants with >= 15 ETDRS letters (>= 3 lines) improvement in the study eye in mLCVA compared to Baseline (Day1 pre-dose) at Day 15
时间窗: Day 15
To evaluate the efficacy of POS to improve mLCVA in subjects with previous keratorefractive surgery
次要结局
- Mean change from Baseline in overall severity of night-time visual disturbances at Day 15 on the NVDPQ(15 Days)
- Mean and change from Baseline in study eye mesopic PD at Day 15(15 Days)
- Mean change from Baseline in severity of glare at Day 15 on the NVDPQ(15 Days)
- Mean and change from Baseline in study eye mLCVA at Day 15(15 Days)
- Percentage of participants with ≥ 15 ETDRS letters (≥ 3 lines) improvement in the study eye in mLCVA compared to Baseline (Day 1 pre-dose) at Day 8(8 Days)
- Mean change from Baseline in Vision and Night Driving Questionnaire (VND-Q) composite score (interval scale) at Day 15(15 Days)
- Mean change from Baseline in VND-Q Item #4 (difficulty seeing the road because of oncoming headlights when driving at night) at Day 15(15 Days)
- Mean change from Baseline in VND-Q Item #5 (difficulty seeing because of glare when driving at dawn or dusk) at Day 15(15 Days)
- Mean change from Baseline in severity of halos at Day 15 on the Night-time Visual Disturbance Participant Questionnaire (NVDPQ)(15 Days)
- Mean change from Baseline in severity of starbursts at Day 15 on the NVDPQ(15 Days)
- Mean and change from Baseline (pre-dose) in study eye mLCVA at 0.5, 1, and 3 hours post dose on Day 1(1 Day)
- Mean and change from Baseline (pre-dose) in study eye mesopic PD at 0.5, 1, and 3 hours post-dose on Day 1(1 Day)
- Percentage of participants with ≥ 15 ETDRS letters improvement in study eye best corrected mHCVA compared to Baseline at Day 15(15 Days)
- Mean and change from Baseline in study eye best corrected mHCVA at Day 15(15 Days)
研究者
研究点 (66)
Loading locations...
相似试验
已完成
2 期
A Study of LY2623091 in Participants With High Blood PressurePrimary HypertensionNCT02194465Eli Lilly and Company304
已完成
2 期
A Study of Enzalutamide and LY3023414 in Men With Prostate CancerProstate Cancer MetastaticNCT02407054Eli Lilly and Company142
已完成
2 期
MK0249 for the Symptomatic Treatment of Alzheimer's Disease (MK0249-011)Alzheimer's DiseaseNCT00420420Merck Sharp & Dohme LLC144
已完成
2 期
A Study to Evaluate the Clinical Efficacy, Safety and Tolerability of ARX-F03 Sublingual Sufentanil/Triazolam NanoTab™ in Patients Undergoing an Elective Abdominal Liposuction ProcedureSedationPainAnxietyNCT00894699Talphera, Inc40
已完成
2 期
Ketamine for the Treatment of Opioid Use Disorder and DepressionOpioid-use DisorderOpioid AbuseDepressionNCT04177706Medical University of South Carolina21