Study on the Effectiveness of Eye-drops Containing Cross-linked Hyaluronic Acid and Coenzyme Q10 in the Treatment of Patients With Mild to Moderate Dry Eye
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 主要终点
- Ocular Surface Disease Index (OSDI) questionnaire.
研究概览
简要总结
Background: Dry eye disease (DED) is a common condition causing burden on visual function and reducing quality of life. Corticosteroids and/or cyclosporine eye drops are able to improve DED symptoms, however, side effects of immune suppression and cost lead patients often to suspend treatment. Consequently, is important to identify therapies alleviating DED symptoms. A randomized, controlled, single masked study, was performed in 40 patients affected by mild to moderate DED, to evaluate efficacy and safety of a collyrium based on cross-linked hyaluronic acid (XLHA) added with Coenzyme Q10 (CoQ10) in comparison to an eye drop considered a gold standard for tear substitutes, based on hyaluronic acid (HA) 0.15%.
Methods: eye drops were administered four times a day for 90 days to enrolled subjects divided in two groups: group A treated with XLHA+CoQ10, group B treated with HA. Ocular Surface Disease Index (OSDI) questionnaire, visual acuity, intraocular pressure (IOP), fundus exam, tear break-up time (TBUT), corneal and conjunctival fluorescein staining, corneal esthesiometry, corneal confocal microscopy, were performed at different visits until the 90th day.
详细描述
Introduction:
Dry eye disease (DED) is a common eye condition causing burden on visual function and reducing quality of life and work productivity. DED is a tear film disorder resulting in hyperosmolarity of tear film and inflammation of ocular surface that results in symptoms of discomfort, visual disturbance, and tear film instability with potential damage to the ocular surface. This condition provokes traumatisms caused by the movement of the eyelids on the ocular surface and an insufficient cleansing of the same by microbial agents and/or foreign bodies.
Prevalence of DED increases with age and women are particularly susceptible, especially those receiving estrogens. The pathogenesis is not fully understood; however, it has been recognized that inflammation has a prominent role .
The most common symptoms of DED are: burning, foreign body sensation in the eye, difficulty in opening the eyelids on awakening, blurred vision and, in severe cases, pain and photophobia. DED is accompanied by increased tear film osmolarity and inflammation of ocular surface.
There is no gold standard treatment for DED, but corticosteroids and/or cyclosporine eye drops improve the symptoms. However, given the side effects of immune suppression and the cost of pharmaceutical preparations, patients often suspend treatment before the effectiveness of therapy can be verified.
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)
盲法说明
Visits were carried out in a blind fashion by investigators who were not aware to which group the patients belonged. The patients were allowed to know the brand name of the eye drops they were using.
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age between 18 and 80 years,
- •history of at least 3 months of dry eye symptoms referable to mild to moderate dry eye.
排除标准
- •presence of any ocular disease, present or past, other than dry eye;
- •previous ocular surgery,
- •use of contact lens or topic treatments other than tear substitutes;
- •presence of systemic diseases requiring a treatment with systemic drugs potentially interfering with tear productions;
- •hypersensitivity to the active substance or to excipients;
- •participation in a clinical trial during the 3 months prior to the beginning of the study,
- •pregnancy or breast-feeding.
研究组 & 干预措施
XLHA+CoQ10
XLHA+CoQ10 eye drop administered four times a day for 12 weeks (90 days).
干预措施: XLHA+CoQ10 (Device)
Hyaluronic acid (HA)
Hyaluronic acid (HA) eye drop administered four times a day for 12 weeks (90 days).
干预措施: Hyaluronic acid (HA) (Device)
结局指标
主要结局
Ocular Surface Disease Index (OSDI) questionnaire.
时间窗: Up to 90 days.
The OSDI is assessed on a scale of 0 to 100, with higher scores representing greater disability. OSDI is a valid and reliable instrument for measuring dry eye disease (normal, mild to moderate, and severe) and effect on vision-related function. OSDI demonstrates sensitivity and specificity in distinguishing between normal subjects and patients with dry eye disease.
Corneal and conjunctival staining.
时间窗: Up to 90 days.
Corneal and conjunctival staining of the ocular surface after instillation of vital dyes was developed to quantify epithelial surface damage in dry eye patients. Ocular surface fluorescein stain score was assessed 3 minutes after the instillation of fluorescein; a modified Oxford score was used: cornea and conjunctiva were scored separately from 0 to 5 (from 0 = none to 5 = extended areas of confluent stain), for the conjunctiva a mean for the scores from the nasal and temporal regions was used. The ocular surface was observed through a cobalt blue light and a Wratten #12 yellow filter.The difference among the scores obtained in each visit was calculated.
次要结局
- Intraocular pressure (IOP).(Up to 90 days.)
- Visual acuity,(Up to 90 days.)
- Fundus exam.(Up to 90 days.)
- Tear break-up time (TBUT).(Up to 90 days.)
- Corneal esthesiometry.(Up to 90 days.)
研究者
Pasquale Aragona
Full Professor of Ophtalmology
Azienda Ospedaliera Universitaria Policlinico "G. Martino"