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

P

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

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%

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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