Skip to content

Clinical Trial on Dry Eyes

Intraglandular platelet rich plasma injection in moderate to severe dry eye disease: A placebo-controlled trial - NIL

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/01/061897
Enrollment
30
Registered
2024-01-29
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: H041- Other disorders of lacrimal gland

Interventions

Intervention1: Platelet rich rich plasma injection: Patients own blood will be collected for plasma formulation and injected in to the gland. The dose is 0.5 to 1cc. Frequency is once in 2 weeks. Rout

Sponsors

L V Prasad Eye Institute
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Mean change from baseline in total corneal stainingTimepoint: week 4, week 12

Secondary

MeasureTime frame
Mean change from baseline in the score of dry eye questionnaires, change in Schirmer values & NIBUT, degree of burning or stinging sensationTimepoint: week 4, week 12

Countries

India

Contacts

Public ContactDr Swati Singh

L V Prasad Eye Institute

swatisingh@lvpei.org04068102123

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026