Assessment of effectiveness of SYSTANE COMPLETE in improving meibomian gland (MG) score and in reducing ocular discomfort symptoms of ocular dryness (Alcon Research, Ltd)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- 1. The mean change in the Ocular surface disease index score (OSDI).
研究概览
简要总结
Dry eye disease (DED), a multifactorial disease of the ocular surface, is one of the most common reasons for frequent patient visits to eye care practitioners, affecting an estimated 30 million people in the US. The global prevalence of DED reported in several large studies ranges from 5% to 50%, with meibomian gland dysfunction (MGD) reported in about 70% of dry eye cases. The symptoms and visual disturbances associated with DED have a negative impact on the daily routine and social or quality of life of patients. Therefore, relief from the symptoms of dryness is critical.4 The treatment goal for DED patients is to improve their ocular comfort by restoring their ocular surface and tear film to a normal state.
PG-HPG nanoemulsion (Systane® Complete [Alcon, Inc., Fort Worth, TX, USA]) lubricant eye drops utilize propylene glycol as the active demulcent with a higher amount of hydroxypropyl guar (HPG) gelling technology than the previous Systane® Balance formulation plus a lipid excipient in smaller nano-sized droplets to optimize the lipid surface coverage with a more translucent appearance. It is intended for patients with dry eye due to either lipid or aqueous deficiency. The unique formulation also contains excipients that can be used in patients with mixed DED. Following the application of PG-HPG nanoemulsion, the HPG/borate meshwork is activated, forming a protective viscoelastic barrier on the surface epithelium. As pH equilibrates and sorbitol is diluted, the viscoelastic HPG meshwork continues to cross-link, maintaining the protective barrier while acting as a depot for the slow release of lipids into the tear film. The anionic phospholipid DMPG (dimyristoyl phosphatidylglycerol) migrates toward the top of the tear film where it fuses with the existing lipids to supplement and stabilize any gaps that have developed due to lipid insufficiency which is caused by MGD. This nanoemulsion formulation restores the complete tear structure to prevent exacerbations of dry eye and maintain a healthier ocular surface.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects ≥ 18years of age both gender
- •Subjects with known case of dry eye disease
- •Best Corrected Visual Acuity (BCVA) of 6/24 [Log MAR equivalent (0.6)] or better
- •Ocular Surface Disease Index (OSDI) :
- •Tear film break-up time (TBUT) ≤ 10 seconds
- •Schirmer tear test (without anesthesia) ≤ 10mm / 5min
- •MGD Score > 20
- •Normal lid position and closure
- •Willingness to sign written informed consent document.
排除标准
- •Any ocular condition that, in the opinion of the Investigator, could affect study parameters.
- •This includes active ocular infection, ocular inflammation, ocular trauma, blepharitis, or, any other condition as deemed by the Investigator.
- •Unwilling to refrain from contact lens use for the entire duration of this study.
- •History of any other ocular surgical procedure within 3 months.
- •Subject with known allergy or hypersensitivity to the components of the formulation.
结局指标
主要结局
1. The mean change in the Ocular surface disease index score (OSDI).
时间窗: 1.baseline and Day 30. | 2.baseline and Day 30
2. The mean change in the MGD scores.
时间窗: 1.baseline and Day 30. | 2.baseline and Day 30
次要结局
- The mean change in the Non-invasive tear film break-up time (NIBUT)(baseline & Day 30.)