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

Pontificia Universidad Catolica de Chile

Status and phase: Unknown; Phase 3

Conditions: Conjunctival Diseases; Sjogren's Syndrome; Lacrimal Apparatus Diseases; Dry Eye; Corneal Diseases; Keratitis; Keratoconjunctivitis Sicca

Treatments: Drug: Autologous Serum 50%; Drug: Autologous Serum 20%

Study type: Interventional

Funder types: Other

Identifiers

NCT03436576

SERUM2050

Details and patient eligibility

About

The purpose of this study is to compare the effects of autologous serum 20% and autologous serum 50% for the treatment of Severe Dry Eye Syndrome

Full description

To determine the difference between autologous serum 20% vs 50%, in terms of improvement of symptoms, improvement of ocular surface parameters and acceptable tolerability in patients with severe dry eye syndrome.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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20 participants in 2 patient groups

Autologous Serum 20%

Active Comparator group

Description:

Treatment with Autologous Serum 20% for 2 months

Treatment:

Drug: Autologous Serum 20%

Autologous Serum 50%

Active Comparator group

Description:

Treatment with Autologous Serum 50% for 2 months

Treatment:

Drug: Autologous Serum 50%