NCT05467293已完成2 期
A Phase 2, Multi-center, Randomized, Double- Masked and Placebo-Controlled Study Evaluating the Efficacy and Safety of YP-P10 Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye (ICECAP 1)
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
- 257
- 试验地点
- 7
- 主要终点
- Total Corneal Fluorescein Staining
研究概览
简要总结
The objective of this study is to compare the safety and efficacy of YP-P10 Ophthalmic Solution to placebo for the treatment of the signs and symptoms of dry eye.
详细描述
The clinical hypotheses for this study is that 0.3% YP-P10 Ophthalmic Solution twice daily (BID) and 1.0% YP-P10 Ophthalmic Solution BID are superior to YP-P10 Placebo Ophthalmic Solution (vehicle) for the primary endpoints of signs and symptoms of dry eye, as follows:
- Sign: Total corneal fluorescein staining score of the study eye using the modified NEI grading scale, measured by mean change from baseline (Visit 2, Pre- Controlled Adverse Environment [CAE®]) to Visit 6
- Symptom: Ocular discomfort score of both eyes using the Visual Analog Scale (VAS) Ocular Discomfort Scale, measured by mean change from baseline (Visit 2, Pre-CAE®) to Visit 6
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, Care Provider, Investigator)
盲法说明
Before the initiation of study run-in at Visit 1, each subject who provides written informed consent will be assigned a screening number. All screening numbers will be assigned in strict numerical sequence at a site and no numbers will skipped or omitted. Each subject who meets all the inclusion and none of the exclusion criteria at Visit 1 and Visit 2 will be assigned a randomization number at the end of Visit 2. The Interactive Web Response System (IWRS) will be used to assign all randomization numbers.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals eligible to participate in this study must meet all of the following criteria:
- •Be at least 18 years of age;
- •Provide written informed consent;
- •Be willing and able to comply with all study procedures;
- •Have a patient-reported history of dry eye for at least 6 months prior to Visit 1;
- •Have a history of use or desire to use eye drops for dry eye symptoms within 6 months of Visit 1;
- •Have a best corrected visual acuity (BCVA) of 0.7 logarithm of the minimum angle of resolution (logMAR) or better (Snellen equivalent score of 20/100 or better) in each eye at Visit 1;
- •Have a score of ≥ 2 for both eyes according to the Ora Calibra® Ocular Discomfort & 4- Symptom Questionnaire in at least one of the dry eye symptoms at Visits 1 and 2;
- •Have an unanesthetized Schirmer's Test score of ≤ 10 mm/5 minutes and ≥ 1 mm/5 minutes in at least one eye at Visits 1 and 2;
- •Have a corneal fluorescein staining score of ≥ 2 according to the Ora Calibra® Corneal and Conjunctival Staining Scale for Grading of Fluorescein Staining in at least one region in one eye at Visits 1 and 2 and a central score ≥ 1 in the same eye;
- •Have a conjunctival redness score ≥ 1 according to the Ora Calibra® Conjunctival Redness for Dry Eye Scale in at least one eye at Visits 1 and 2 pre-CAE®;
- •Demonstrate in the same eye(s) a response to the CAE® at Visits 1 and 2 as defined by:
- •Having at least a ≥1 point increase in fluorescein staining in the inferior region in at least one eye following CAE® exposure; a. Reporting an Ocular Discomfort score ≥ 3 at 2 or more consecutive time points in at least one eye during CAE® exposure (if a subject has an Ocular Discomfort rating of 3 at time = 0 for an eye, s/he must report an Ocular Discomfort rating of 4 for two consecutive measurements for that eye). Note: a subject cannot have an Ocular Discomfort score of 4 at time = 0);
- •Have at least one eye, the same eye, satisfy all criteria for 8, 9, 10 and 11 above;
- •A negative urine pregnancy test if female of childbearing potential (those who are not surgically sterilized [bilateral tubal ligation, hysterectomy or bilateral oophorectomy] or post-menopausal [12 months after last menses]) and must use adequate birth control through the study period. For non-sexually active females, abstinence may be regarded as an adequate method of birth control.)
排除标准
- •Individuals who meet any of the following exclusion criteria will not be eligible to participate in the study:
- •Have any clinically significant slit lamp findings at Visit 1 that may include active blepharitis, meibomian gland dysfunction, lid margin inflammation, or active ocular allergies that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters;
- •Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1;
- •Have worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses during the study;
- •Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months;
- •Have used Restasis®, Xiidra®, or Cequa®, Eysuvis™ and Tyrvaya™ within 60 days of Visit 1;
- •Have had any ocular and/or lid surgeries in the past 6 months or have any planned ocular and/or lid surgeries over the study period;
- •Be using or anticipate using temporary punctal plugs during the study that have not been stable within 30 days of Visit 1;
- •Be currently taking any topical ophthalmic prescription (including medications for glaucoma) or over-the-counter solutions, artificial tears, gels or scrubs, and cannot discontinue these medications for the duration of the trial (excluding medications allowed for the conduct of the study); the respective wash- out periods are required for the following medications:
- •Antihistamines (including ocular): 72 hours prior to Visit 1
- •Oral aspirin or aspirin-containing products allowed if dose has been stable over past 30 days prior to Visit 1 and no change in dose is anticipated during the study period
- •Corticosteroids or mast cell stabilizers (including ocular): 14 days prior to Visit 1
- •Any medication (oral or topical) known to cause ocular drying that has not been administered as a stable dose for at least 30 days prior to Visit 1 and during the study
- •All other topical ophthalmic preparations (including artificial tear substitutes) other than the study drops: 72 hours prior to Visit 1
- •Have an uncontrolled systemic disease;
- •Be a woman who is pregnant, nursing, or planning a pregnancy;
- •Be unwilling to submit a urine pregnancy test at Visit 1 and Visit 6 (or early termination visit) if of childbearing potential. Non- childbearing potential is defined as a woman who is permanently sterilized (e.g., has had a hysterectomy or tubal ligation), or is post- menopausal (without menses for 12 consecutive months);
- •Be a woman of childbearing potential who is not using an acceptable means of birth control; acceptable methods of contraception include: hormonal - oral, implantable, injectable, or transdermal contraceptives; mechanical - spermicide in conjunction with a barrier such as a diaphragm or condom; intrauterine device; or surgical sterilization of partner. For non-sexually active females, abstinence may be regarded as an adequate method of birth control; however, if the subject becomes sexually active during the study, she must agree to use adequate birth control as defined above for the remainder of the study;
- •Have a known allergy and/or sensitivity to the test article or its components;
- •Have a condition or be in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study;
- •Be currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days of Visit 1;
- •Be unable or unwilling to follow instructions, including participation in all study assessments and visits.
研究组 & 干预措施
YP-P10 Placebo Ophthalmic Solution (vehicle)
Placebo Comparator
干预措施: YP-P10 Placebo Ophthalmic Solution (vehicle) (Drug)
0.3% YP-P10 Ophthalmic Solution
Active Comparator
干预措施: 0.3% YP-P10 Ophthalmic Solution (Drug)
1% YP-P10 Ophthalmic Solution
Active Comparator
干预措施: 1% YP-P10 Ophthalmic Solution (Drug)
结局指标
主要结局
Total Corneal Fluorescein Staining
时间窗: Day 85
Modified National Eye Institute Scale; 0-20: Higher is Worse
Ocular Discomfort Score
时间窗: Day 85
Visual Analogue Scale; 0-100: Higher is Worse
次要结局
- Lissamine Green Staining: Temporal(13 weeks)
- Lissamine Green Staining: Inferior Nasal(13 weeks)
- Lissamine Green Staining: Conjunctival Sum(13 weeks)
- Ocular Surface Disease Index (OSDI): Subtotal 1-5(13 weeks)
- Pain in Eyes(13 Weeks)
- Fluorescein Staining: Nasal(13 weeks)
- Conjunctival Redness(13 weeks)
- Ocular Surface Disease Index (OSDI): Subtotal 6-9(13 weeks)
- Ocular Surface Disease Index (OSDI): Subtotal 10-12(13 weeks)
- Ocular Surface Disease Index (OSDI): Total(13 weeks)
- Burning/Stinging(13 weeks)
- Itching(13 weeks)
- Foreign Body Sensation(13 Weeks)
- Blurred Vision(13 Weeks)
- Eye Dryness(13 Weeks)
- Photophobia(13 Weeks)
- Fluorescein Staining: Superior(13 weeks)
- Fluorescein Staining: Central(13 weeks)
- Fluorescein Staining: Inferior(13 weeks)
- Fluorescein Staining: Temporal(13 weeks)
- Lissamine Green Staining: Nasal(13 weeks)
- Unanesthetized Schirmer's Test(13 weeks)
- Tear Film Break-up Time (TFBUT)(13 weeks)
- Lissamine Green Staining: Inferior Temporal(13 weeks)
- Lissamine Green Staining: Superior Temporal(13 weeks)
- Lissamine Green Staining: Superior Nasal(13 weeks)
- Adverse Event Query - SEA Reported(13 Weeks)
- Dilated Fundoscopy: Shift From Normal/Abnormal NCS to Abnormal CS(13 weeks)
- Intraocular Pressure (IOP) by Contact Tonometry by the Examiner: Unsafe and Abnormal Ranges(13 weeks)
- Treatment Compliance Using a Daily Compliance Diary(13 weeks)
- Drop Comfort - Positive Response(13 weeks)
- Visual Acuity - Subjects With Increase Greater Than 0.2 logMAR(13 weeks)
- Slit-lamp Evaluation Biomicroscopy - Subjects That Had a Shift From Normal/Abnormal NCS to Abnormal CS(13 weeks)
- Adverse Event Query - TEAEs(13 weeks)
- Adverse Event Query - Ocular TEAEs(13 Weeks)
- Adverse Event Query - Non Ocular TEAEs(13 Weeks)
- Adverse Event Query - TEAEs Causing Premature Treatment Discontinuation(13 Weeks)
- Adverse Event Query - TEAEs Suspected to be Related to Study Drug(13 Weeks)
研究者
研究点 (7)
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