Efficacy of Two Concentrations of Autologous Serum for the Treatment of Severe Dry Eye

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03436576
• Date of registration: 12/02/2018
• Prospective Registration: Yes
• Primary sponsor: Pontificia Universidad Catolica de Chile
• Public title: Efficacy of Two Concentrations of Autologous Serum for the Treatment of Severe Dry Eye
• Scientific title: Comparison of Autologous Serum 20% and Autologous Serum 50% for the Treatment of Severe Dry Eye
• Date of first enrolment: September 12, 2018
• Target sample size: 20
• Recruitment status: Unknown status
• URL: https://clinicaltrials.gov/show/NCT03436576
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 3

Countries of recruitment

Chile

Contacts

• Name: Paulina Liberman, MD
• Affiliation: Pontificia Universidad Catolica de Chile

Key inclusion & exclusion criteria

Inclusion Criteria:

- Man/woman = 18 years old, able to freely give consent to participate in the study

- At least 1 of the following tests altered:

- Ocular Surface Disease Index (OSDI) Test symptoms > 32

- BUT =5 seconds

- Oxford staining = 3

- Schirmer Test without anesthesia = 5 mm

Exclusion Criteria:

- Sensitivity or known intolerance to any of the products used in the study

- Contraindication of venipuncture

- Story of ocular infections within the 6 previous months to study inclusion

- Any active ocular pathology other than Dry Eye Syndrome

- Use of contact lenses in the 3 previous months to study inclusion

- No pregnant or breastfeeding women is allowed to participate in the study.
Childbearing potential women must use contraceptive means during the whole study.

- Participation in another clinical trial in the last 30 days before study inclusion



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Conjunctival Diseases

Corneal Diseases

Keratitis

Keratoconjunctivitis Sicca

Sjogren's Syndrome

Dry Eye

Lacrimal Apparatus Diseases

Intervention(s)

Drug: Autologous Serum 50%

Drug: Autologous Serum 20%

Primary Outcome(s)

Change in Ocular Surface Disease Index (OSDI) Score [Time Frame: 1 month]

Secondary Outcome(s)

Change in Tear Break Up Time (TBUT) [Time Frame: 1 week, 1 month, 2 months]

Change in Oxford Staining score [Time Frame: 1 week, 1 month, 2 months]

Change in Schirmer I [Time Frame: 1 week, 1 month, 2 months]

Change in Ocular Surface Disease Index (OSDI) Score [Time Frame: 1 week, 2 months]

Secondary ID(s)

SERUM2050

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Hospital Dr Sotero del Rio