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

Phase 3

• Conditions: Keratoconjunctivitis Sicca; Corneal Diseases; Keratitis; Lacrimal Apparatus Diseases; Sjogren's Syndrome; Conjunctival Diseases; Dry Eye
• Interventions: Drug: Autologous Serum 20%; Drug: Autologous Serum 50%

• Registration Number: NCT03436576
• Lead Sponsor: Pontificia Universidad Catolica de Chile

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2018-02-12
• Study First Submitted QC: 2018-02-15
• Study First Posted: 2018-02-19
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-31
• Last Update Posted: 2018-09-05
• Study Start: 2018-09-12
• Primary Completion: 2018-10-19
• Study Completion: 2018-11-19

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Autologous Serum 20%	Autologous Serum 20%	Treatment with Autologous Serum 20% for 2 months
Autologous Serum 50%	Autologous Serum 50%	Treatment with Autologous Serum 50% for 2 months

Primary Outcome Measures

Name	Time	Method
Change in Ocular Surface Disease Index (OSDI) Score	1 month	The Ocular Surface Disease Index (OSDI) is a 12-item questionnaire designed to provide a rapid assessment of the symptoms of ocular irritation consistent with dry eye disease and their impact on vision-related functioning.; The overall OSDI score defines the ocular surface as normal (0-12 points) or as having mild (13-22 points), moderate (23-32 points), or severe (33-100 points) disease.

Secondary Outcome Measures

Name	Time	Method
Change in Ocular Surface Disease Index (OSDI) Score	1 week, 2 months	The Ocular Surface Disease Index (OSDI) is a 12-item questionnaire designed to provide a rapid assessment of the symptoms of ocular irritation consistent with dry eye disease and their impact on vision-related functioning.; The overall OSDI score defines the ocular surface as normal (0-12 points) or as having mild (13-22 points), moderate (23-32 points), or severe (33-100 points) disease.
Change in Schirmer I	1 week, 1 month, 2 months	It is a tear production test. The Schirmer I test is performed without anesthesia. Two thin strips of filter paper (Whatman 5mm x 35mm) are placed on the bottom of the lower conjunctival sac at the junction of the middle third and the outer third to prevent injury to the cornea. It is recommended to ask the subject to keep their eyes closed to limit the effect of blinking. The strips are kept positioned for 5 minutes and then they are removed and the amount that was moistened is read, in mm.; The lower the value, the greater the deficit of tear production
Change in Tear Break Up Time (TBUT)	1 week, 1 month, 2 months	The TBUT is based on the time of tear rupture after the instillation of fluorescein.; The shorter the time of rupture, the greater the tear dysfunction
Change in Oxford Staining score	1 week, 1 month, 2 months	The Oxford scale is based on the amount of ocular surface (cornea and conjunctiva) that is stained with lysine or green fluorescein. The severity of the staining points is classified into 6 stages (0-5) from absent to marked epithelial damage.

Trial Locations

Locations (1)

Hospital Dr. Sótero del Río; 🇨🇱 Puente Alto, Región Metropolitana, Chile