A Phase 3 Randomized, Placebo-Controlled, Double-Masked, Multicenter, Safety and Efficacy Study of Brimonidine Tartrate 0.2% Nanoemulsion Eye Drops in Patients With Dry Eye Disease (DED)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Ocugen
- 入组人数
- 252
- 试验地点
- 16
- 主要终点
- Change From Baseline to 4 Weeks (Day 28) in Symptom Assessment in Dry Eye (SANDE) Questionnaire Score
研究概览
简要总结
This study evaluates the use of Brimonidine tartrate nanoemulsion eye drop solution in the treatment of Dry Eye Disease (DED). Half of participants will receive Brimonidine and half will receive ophthalmic buffered saline (placebo).
详细描述
Dry eye disease (DED) is a common ocular disorder involving the aberrant production and instability of tear film, which results in damage to the ocular surface and is correlated with symptoms of ocular discomfort.
This study will be a randomized, placebo-controlled, double-masked, multicenter phase 3 study in the United States conducted at approximately 25 centers. Upon meeting the eligibility criteria, enrolled subjects will be randomly assigned in a 1:1 (test:control) fashion to receive either Brimonidine Nanoemulsion Eye Drops 0.20% investigational product (test) or ophthalmic buffered saline (placebo).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 years or older.
- •Sign and date informed consent form approved by the IRB
- •History of Dry Eye Disease for ≥6 months
- •Demonstrate the following 2 signs of DED in the same eye at Screening and Baseline (Day 1):
- •Conjunctival staining at ≥3 (out of a possible score of 6 per eye), and
- •Schirmer test (with anesthesia) at ≥1 to ≤7mm in 5 minutes
- •Symptomatic evidence of DED by having a global symptom score (Overall SANDE) ≥40 mm at Screening and Baseline (Day 1) visit
- •Intraocular pressure (IOP) ≥ 5 mmHg and ≤22 mmHg in each eye
- •Women who satisfy one of the following:
- •8a. Are of child-bearing potential (WOCP) who are not pregnant or lactating and who are either abstinent or sexually active on an acceptable method of birth control for at least 4 weeks prior to Visit 1 and throughout the study (i.e., until Day 28), OR 8b. Are post-menopausal or have undergone a sterilization procedure
排除标准
- •Allergic to brimonidine or any similar products, or excipients of brimonidine
- •Use of contact lenses within 14 days prior to Screening visit or planned use during study
- •Currently receiving brimonidine or other treatment for glaucoma or ocular hypertension or history of glaucoma surgery.
- •Receiving or have received any experimental or investigational drug or device within 30 days prior to Screening visit
- •Intraocular pressure <5 mmHg or >22 mmHg in either eye
- •Active ocular infection or history of ocular herpetic keratitis
- •History of neurotrophic keratitis or ocular neuropathic pain
- •Any history of eyelid surgery or intraocular/ocular surgery within the past 3 months
- •Punctal occlusion within 3 months prior to Screening visit or during study
- •Corneal epithelial defect larger than 1 mm2 in either eye
- •Have active drug/alcohol dependence or abuse history
- •Are neonates, pregnant/lactating women, children, or others who may be considered vulnerable populations
- •Received corticosteroid-containing eye drops within 14 days prior to Screening visit or planned use during study
- •Any change in systemic corticosteroids/immunosuppressives, cyclosporine ophthalmic emulsion 0.05% (Restasis®), cyclosporine ophthalmic solution 0.09% (Cequa™), or lifitegrast ophthalmic solution 5% (Xiidra®) within 30 days prior to Screening visit or planned change during study
- •In the opinion of Investigator or Study Coordinator, be unwilling or unable to comply with study protocol or unable to successfully instill eye drops
- •Disease, condition, or disorder that in the judgement of Investigator could confound study assessments or limit compliance to study protocol
研究组 & 干预措施
Placebos
Ophthalmic buffered saline Eye Drops given 2 times a day for 4 weeks
干预措施: Placebos (Drug)
OCU-310
Brimonidine Tartrate Nanoemulsion Eye Drops 0.20% given 2 times a day for 4 weeks
干预措施: Brimonidine Tartrate (Drug)
结局指标
主要结局
Change From Baseline to 4 Weeks (Day 28) in Symptom Assessment in Dry Eye (SANDE) Questionnaire Score
时间窗: Baseline, 4 weeks (Day 28)
The SANDE questionnaire is a short Visual Analog Scale (VAS) assessment that quantifies both severity and frequency of current dry eye symptoms. The SANDE is comprised of two questions, and each question employs a 100-mm horizontal linear VAS. The measurement of symptom frequency ranges from "rarely" to "all of the time", and the symptom severity from "very mild" to "very severe". Data collected from the SANDE questionnaire was calculated by multiplying the frequency score by the severity score and obtaining the square root. The result is the Overall SANDE score which ranges from 0 to 100 with 100 being the maximal amount of dry eye symptoms and 0 being the minimal amount of dry eye symptoms.
Change From Baseline to 4 Weeks (Day 28) in Lissamine Green Conjunctival Staining Scores
时间窗: Baseline, 4 Weeks (Day 28)
Conjunctival staining with Lissamine Green dye (1%; LG) staining in each eye was conducted using the slit lamp. A single drop of 1% Lissamine Green dye was applied to the inferior conjunctival fornix of both eyes. The conjunctivae was examined with the slit lamp at ×10 magnification, using a neutral-density filter. The conjunctiva was graded for each eye from 0 to 3 based on the density of punctate staining in the nasal-bulbar and temporal-bulbar zones. Total scores ranged from 0 (no staining) to 6 (most severe staining) with a lower score representing a more desirable outcome.
次要结局
- Change From Baseline to 2 Weeks (Day 14) in SANDE Score(Baseline, 2 weeks (Day 14))
- Change From Baseline to 2 Weeks (Day 14) in Lissamine Green Conjunctival Staining Scores(Baseline, 2 Weeks (Day 14))