NCT02871440已完成3 期
A Two Comparator, Controlled Phase 3 Study of OM3 Tear Formulation Versus OPTIVE ADVANCED Unit Dose and OPTIVE Unit Dose Eye Drops in Patients With and Without Evaporative Dry Eye.
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
- 40
- 主要终点
- Tear Evaporation Rate
研究概览
简要总结
Omega 3 (OM3) Tear is a new unit dose emulsion, containing flaxseed/castor oil, which is being developed by Allergan. It is desirable to understand the effect that this new emulsion has on tear film evaporation and tear lipid profile via interferometry, in patients with evaporative dry eye (EDE) and those without (non-EDE). It would also be valuable to evaluate the retention time of the lipid components of the new emulsion via tear collection and analysis in EDE and non-EDE patients
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
- Single (Investigator)
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
- •Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent;
- •Over 18 years of age;
- •Not wearing contact lenses in the past 3 months before enrolling
- •Willing to use eye drops and comply with the study visit schedule as directed by the Investigator;
- •Habitual (corrected or uncorrected) visual acuity of 6/9.5 or better in each eye;
- •At the Screening visit (Day -14), patients must have Ocular Surface Disease Index (OSDI) score >18 (0 to 100 scale). At Baseline (Day 1) visits, patients must have OSDI score > 12 to continue in the study.
- •TBUT≤10sec in at least 1 eye at Screening visit and Baseline visit
- •Corneal sodium fluorescein staining score ≥ 1 and <4 (Oxford scheme) at Screening and Baseline visit.
排除标准
- •Schirmer test (with anesthesia) ≤ 2 mm in either eye at Screening
- •Patients who are currently using topical ocular medication or have used topical ocular medication within 2 weeks of the Screening visit. Patients who are being treated bilaterally with a marketed artificial tear for dry eye can be considered, provided they discontinue use at the Screening visit;
- •Any active anterior segment disease excluding blepharitis;
- •Any systemic disease that may affect ocular health e.g. Graves disease, and auto-immune diseases such as ankylosing spondylitis, multiple sclerosis and systemic lupus erythematosus;
- •History of epilepsy or migraines exacerbated by flashing, strobe-like lights;
- •Rigid or soft contact lens wearer, including orthokeratology;
- •History of eye surgery within 6 months prior to enrolment in the study;
- •Previous corneal refractive surgery
研究组 & 干预措施
Eye drop 1
Experimental
Omega 3
干预措施: Omega 3 (Drug)
Eye drop 2
Active Comparator
Optive Advanced
干预措施: Optive Advanced (Drug)
Eye drop 3
Active Comparator
Optive
干预措施: Optive (Drug)
结局指标
主要结局
Tear Evaporation Rate
时间窗: Assessed at 4 weeks
Measured using a Vapometer (g/m\^2\*h)
次要结局
- Tear Break-up Time(Assessed at 4 weeks)
- Subjective Ocular Comfort(Assessed at 4 weeks)
研究者
Jacqueline Tan-Showyin
Research Fellow
The University of New South Wales
相似试验
已完成
4 期
The HOME Study (HPN With OMEGA-3)Patients Requiring Home Parenteral NutritionNCT03282955B. Braun Melsungen AG74
终止
1 期
Omega-3 Fatty Acids in Sickle Cell DiseaseSickle Cell DiseaseNCT02947100Robin E. Miller4
已完成
3 期
Multi_center Study to Evaluate the Effect of N-3 Fatty Acids (OMEGA-3) on Arrhythmia Recurrence in Atrial FibrillationAtrial FibrillationNCT01235130Montreal Heart Institute337
已完成
3 期
MK-0431/ONO-5435 Phase III Clinical Trial - Insulin Add-on Study for Patients With Type 2 Diabetes MellitusType 2 Diabetes MellitusNCT00854035Ono Pharmaceutical Co. Ltd266
撤回
不适用
Omega-3 Fatty Acids in Treating Patients With Advanced Prostate CancerStage III Prostate CancerNCT00996749Wake Forest University Health Sciences