A randomized controlled trial comparing efficacy and safety of two tear substitutes 0.5 percent Carboxymethylcellulose (CMC) versus 0.3 percent hydroxypropyl methylcellulose (HPMC)in patient with mild to moderate dry eye disease.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 148
- 试验地点
- 1
- 主要终点
- To compare the efficacy of 0.5%
研究概览
简要总结
Dry eye disease can potentially cause
damage to the ocular surface and cause
symptoms such as pain, visual impairment,
and instability of the tear film.
According to the Tear Film & Ocular
Surface Society Dry Eye Workshop II
(TFOS DEWS II) dry eye diseases is
defined as “A multifactorial disease of the
ocular surface characterized by a loss of
homeostasis of the tear film, and
accompanied by ocular symptoms, in
which tear film instability and
hyperosmolarity, ocular surface
inflammation and damage, and
neurosensory abnormalities play
etiological roles’’CMC and HPMC both have been used by
various studies with the result showing
their efficacy in dry eye diseases in mild to
moderate dry eye.While reviewing literature evaluating
comparative efficacy of both the drugs in
mild to moderate dry eye diseases, no
controlled trial or RCT have been found in
Indian population. It is important to know
that although various observational studies
show efficacy of these drugs, but to have a
definitive conclusion regarding which drug
is superior/ recommended needs a
comparative trial which will be useful for
clinicians for choosing the best drug in
their clinical practice as well as patient
acceptability. This RCT is designed to find
out all these answers.Patient will be recruited from
ophthalmology OPD, AIIMS,
Guwahati. The diagnosis of the case
will be done by ophthalmologist for
recruiting the study participants.
Severity of dry eye will be graded as
per DEWS II classification. Detailed
history and baseline examination
findings will be recorded in a case
record form after taking informed
written consent from the patients
explaining in their local language.
Patients fulfilling inclusion/exclusion
criteria and providing written informed
consent will be recruited for the study.
After recruiting the case, eligible
patient will be randomized into two
treatment groups that is Group A: CMC
0.5% group (0.5% CMC four times in a
day) and Group B: HPMC 0.3% group
(0.3% HPMC 4 times in a day) .All population fulfilling inclusion
exclusion criteria and willing to
provide written informed consent will
be randomized
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Mild to moderate dry eye disease (At least in one eye) as per DEWS II Definition.
- •who is willing to take part in the study and ready to give informed consent form.
- •Patients with age between 18- 50 yrs
- •OSDI score15-
- •Schirmer test ≥5-10 mm at 5 min without anaesthesia.
排除标准
- •Patient who cannot give informed consent.
- •Subject using contact lens.
- •Page 9 of 13
- •Eyelid or blinking disorder.
- •Pregnant and lactating women.
- •Patient on local/systemic immunosuppressants.
- •Cancer and other clinically important diseases.
- •Having severe ocular surface disease.
- •Having ocular infection.
- •History of allergy to any ocular medications/Any drugs.
结局指标
主要结局
To compare the efficacy of 0.5%
时间窗: 15 days
carboxymethylcellulose and 0.3%
时间窗: 15 days
hydroxypropyl methyl cellulose in
时间窗: 15 days
terms of improvement in OSDI.
时间窗: 15 days
次要结局
- 1. To compare the efficacy of(0.5% carboxymethylcellulose)
研究者
Dr Phulen Sarma
Pharmacology, AIIMS Guwahati