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Clinical Trial on Dry Eyes

Phase 3
Conditions
Health Condition 1: H041- Other disorders of lacrimal gland
Registration Number
CTRI/2024/01/061897
Lead Sponsor
V Prasad Eye Institute
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

1. Aged 18–70 years

2. Have OSDI scores =33 or Oxford staining grade =2

3. Have a best corrected visual acuity (BCVA) in both eyes of +0.7 logMAR

4.Diagnosis of DED in both eyes supported by the criteria mentioned below

Defined by at least one eye meeting all the following criteria:

o A symptom severity score of =22 for OSDI

oAn unanesthetized Schirmer Tear Test (STT) score of =1 mm and =5 mm per 5 minutes

oEvidence of ocular surface staining (total fluorescein staining score of at least 3) [0-15 scale])

5. Have normal lid anatomy and no other ocular disease except refractive errors or cataract

Exclusion Criteria

1. Uncontrolled systemic diseases, active infection or chronic kidney disease, liver cirrhosis, advance cancer.

2. Pregnant or nursing women.

3.Have not recently used the following medications, interventions, surgery, Anticoagulants or anti-platelets,Topical undiluted blood products within 3 months, Punctal plug or contact lenses, Ocular surgery within 6 months.

4.Have no contraindication for blood donation, Positive HIV, hepatitis B or C, or syphilis, Anaemia.Hemoglobin less than 110 grams per Litre.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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