Clinical trial on dry eye patients
- Conditions
- Health Condition 1: null- Mild to moderate dry eye diseaseHealth Condition 2: H100- Mucopurulent conjunctivitis
- Registration Number
- CTRI/2018/01/011121
- Lead Sponsor
- arayana Nethralaya
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
1.Males and Females
2.Age 18 to 65 years,
3.Mild to moderate dry eye disease as per:
i.OSDI score >18
ii.Schirmers II (with anaesthesia) >5 at 5 minutes, < 10 at 5 minutes
iii.TBUT < 7 seconds
iv.Corneal and conjunctival staining ( graded
by NEI and Van Bjisterveld grading)
4.No use of any tear substitute for either eye in the preceding 6 weeks
5.Willing to participate in the study
Inclusion criteria for Arm 2:
6.All patients undergoing corneal refractive surgery without pre-existing dry eye
7.Willing to participate in the study
1.BCVA distance < 6/60
2.Severe blepharitis
3.Eyelid malposition
4.Corneal scar/ opacity
5.Ocular Surface Squamous neoplasia (OSSN)
6.Corneal neovascularisation or pannus
7.cular allergy (except in paediatric population)
8.Any ocular infection in the past 3 months
9.Cataract surgery in the past 3 months
10.Corneal or conjunctival procedure
11.Ocular medications which are known to worsen dry eye like AGM
12.Systemic conditions like collagen vascular disease, rheumatoid arthritis, Steven Johnson syndrome
Exclusion criteria for arm 2
13.Pre-existing dry eye
14.Corneal neovascularisation or pannus
15.Ocular allergy (except in paediatric population)
16.Any ocular infection in the past 3 months
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.The changes in various ocular surface signs and symptoms and quantitative and qualitative analysis of tear film in dry eye induced secondary to laser refractive surgery and effect of various topical eye medications on it <br/ ><br>Timepoint: 10 days, 1 month, 3 months and 6 months
- Secondary Outcome Measures
Name Time Method To study the inflammatory pathways involved in dry eye and action of each of the medications on those pathwaysTimepoint: 6 Months