Clinical trial NCT04683796: Comparison of Efficacy Between 100% Platelet-rich Plasma and 100% Serum Eye Drops in Dry Eye Disease
Official title: Comparison of Treatment Efficacy Between 100% Platelet-rich Plasma and 100% Serum Eye Drops in Moderate to Severe Dry Eye Disease: A Randomized Controlled Trial Protocol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dry Eye Disease
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2020-12-24
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomly allocated to receive either 100% APRP or 100% AS (the same treatment for both eyes).
Primary purpose: TREATMENT

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 burden as high as over 50 billion from a societal perspective. Several biological tear substitutes (e.g., autologous serum (AS), autologous platelet rich plasma (APRP), and autologous platelet lysate (APL)) could effectively improve dry eyes, especially in patients with moderate to severe DED.. However, evidence on their comparative efficacy is controversial. The objective of the study is to compare the efficacy of 100% APRP with 100% AS eye drops in patients with moderate to severe DED.

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 and will be randomized to receive either 100% APRP or 100% AS eye drops (1:1 ratio) for 4 weeks. The primary outcomes include ocular surface disease index (OSDI) and ocular surface staining evaluated using the Oxford scale. Secondary outcomes are fluorescein break-up time (FBUT), Schirmer's I test (ST I), meibomian gland parameters and adverse events.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

• None

Primary outcomes:
measure: Ocular surface score index (OSDI)
timeFrame: 4 weeks
measure: Ocular surface staining (OSS)
timeFrame: 4 weeks
Secondary outcomes:
measure: Fluorescein break up time (FBUT)
timeFrame: 4 weeks
measure: Schirmer's test (ST)
timeFrame: 4 weeks
measure: Meibum quality and expressibility.
timeFrame: 4 weeks
measure: Number of patients with ocular adverse events
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Ratchathewi
country: Thailand
facility: Ophthalmology Department, Ramathibodi Hospital
state: Bangkok
Study officials:
affiliation: Department of Clinical Epidemiology and Biostatistics, Mahidol University, Thailand
name: Ammarin Thakkinstian, Ph.D.
role: STUDY_DIRECTOR
References:
citation: Jongkhajornpong P, Numthavaj P, Anothaisintawee T, Lekhanont K, McKay G, Attia J, Thakkinstian A. Comparison of treatment efficacy between 100% platelet-rich plasma and 100% serum eye drops in moderate-to-severe dry eye disease: a randomised controlled trial protocol. BMJ Open. 2021 Jun 30;11(6):e048479. doi: 10.1136/bmjopen-2020-048479.