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临床试验/CTRI/2023/02/049510
CTRI/2023/02/049510已完成不适用

A comparative study of efficacy and safety of polyethylene glycol and sodium hyaluronate in dry eye disease

Pt BD Sharma PGIMS Rohtak1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年2月14日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
1
主要终点
1. Schirmer-1 test

研究概览

简要总结

Dry eye disease is defined as “a multifactorial disease of the tears and ocular surface that results in symptoms of discomfort, visual disturbance, and tear film instability with potential damage to the ocular surface. It is accompanied by an increase in the tear film’s osmolarity and sub-acute ocular surface inflammation." Keratoconjunctivitis sicca(KCS), keratitis sicca, Sicca syndrome, Xeropthalmia, dry eye disease (DED) ocular surface disease (OSD), dysfunctional tear syndrome (DTS). The disruption of the lacrimal functional unit is known to cause dry eye. Lacrimal glands, the ocular surface including cornea, conjunctiva, eyelids, meibomian glands, ocular nerves, and goblet cells make up the lacrimal functional unit. Inclusion criteria - Patients of either gender > 18 years of age, Patients diagnosed with moderate dry eye disease (score 9-13) according to Khurana’s scoring system, and Patients willing to give written informed consent..   Exclusion criteria Patients with Any structural abnormalities, Pregnant and lactating, women,, Hypertension, Glaucoma, Diabetes, History of allergy to study medication. Group A- 25 patients with polyethylene glycol eye drops 0.1% TDS for 6 weeks and Group B- 25 patients with sodium hyaluronate eye drops 0.1%TDS for 6 weeks.Schirmer-1 test ,Tear break-up time, Rose Bengal staining score, Fluorescein staining, Lissamine green staining,(0, 2, and 6 weeks).Goblet cell conjunctival impression cytology ,OSDI (0 and 6 weeks). likert scale and safety assesment  2 and weeks.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

入排标准

年龄范围
18.00 Year(s) 至 55.00 Year(s)(—)
性别
All

入选标准

  • Patients of either gender > 18 years of age.
  • Patients diagnosed with moderate dry eye disease (score 9-13) according to Khurana’scoring system.
  • Patients willing to give written informed consent.

排除标准

  • Any structural abnormalities Pregnant and lactating women.
  • Hypertension Glaucoma.
  • History of allergy to study medication.

结局指标

主要结局

1. Schirmer-1 test

时间窗: Safety assessment will be carried out for all the treatment groups at 2 and 6 weeks

2. Tear break-up time (in seconds)

时间窗: Safety assessment will be carried out for all the treatment groups at 2 and 6 weeks

3. Rose Bengal staining score

时间窗: Safety assessment will be carried out for all the treatment groups at 2 and 6 weeks

4. Goblet cellconjunctivalimpression cytology

时间窗: Safety assessment will be carried out for all the treatment groups at 2 and 6 weeks

次要结局

  • 1. Fluorescein staining(2. Lissamine green staining)

研究者

发起方
Pt BD Sharma PGIMS Rohtak
申办方类型
Government medical college

研究点 (1)

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