Status:
COMPLETED
Comparison of Efficacy Between 100% Platelet-rich Plasma and 100% Serum Eye Drops in Dry Eye Disease
Lead Sponsor:
Mahidol University
Conditions:
Dry Eye Disease
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
Dry eye disease (DED) is a common eye problem, affecting 5% to 50% of the world population. Although the disease is not fatal, it substantially reduces quality of life and creates a high economic burd...
Detailed Description
The study is a single-center, double-blinded randomized, parallel, non-inferiority trial. Patients will be recruited from out-patient clinic, Department of Ophthalmology, Ramathibodi Hospital, Bangkok...
Eligibility Criteria
Inclusion
- Aged 18 to less than 75 years.
- Have OSDI scores ≥ 23 or Oxford staining grade ≥ 2.
- Do not have following conditions:
- Uncontrolled systemic diseases, active infection, advanced cancer. Pregnant and nursing women. • 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.
- Do not have active ocular infection/inflammation, abnormal eyelid function or severe meibomian gland dysfunction (MGD stage 4).
- Have no contraindication for blood donations:
- Positive human immunodeficiency virus, hepatitis B or C, or syphilis. Anemia (Hb \< 11 g/dL) or platelet concentration \< 150,000/ml.
- Being able to stop current dry eye treatment for 48 hours before staring trial intervention
- Willing to comply with the 4-week study protocol and provide informed consent.
Exclusion
- • None
Key Trial Info
Start Date :
February 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 30 2023
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT04683796
Start Date
February 1 2021
End Date
March 30 2023
Last Update
October 23 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Ophthalmology Department, Ramathibodi Hospital
Ratchathewi, Bangkok, Thailand, 10400