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

Sponsor

Pontificia Universidad Catolica de Chile (Other)

Overall Status

Unknown status

CT.gov ID

NCT03436576

Collaborator

Hospital Dr Sotero del Rio (Other)

Enrollment

Location

Arms

2.2

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Keratoconjunctivitis Sicca Sjogren's Syndrome Corneal Diseases Conjunctival Diseases Keratitis Lacrimal Apparatus Diseases	Drug: Autologous Serum 20% Drug: Autologous Serum 50%	Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

Comparison of Autologous Serum 20% and Autologous Serum 50% for the Treatment of Severe Dry Eye

Anticipated Study Start Date :

Sep 12, 2018

Anticipated Primary Completion Date :

Oct 19, 2018

Anticipated Study Completion Date :

Nov 19, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Autologous Serum 20% Treatment with Autologous Serum 20% for 2 months	Drug: Autologous Serum 20% Instillation of 1 drop of Autologous Serum 20% four times a day Other Names: Autologus serum low concentration
Active Comparator: Autologous Serum 50% Treatment with Autologous Serum 50% for 2 months	Drug: Autologous Serum 50% Instillation of 1 drop of Autologous Serum 50% four times a day Other Names: Autologus serum high concentration

Arm

Intervention/Treatment

Active Comparator: Autologous Serum 20%

Treatment with Autologous Serum 20% for 2 months

Drug: Autologous Serum 20%

Instillation of 1 drop of Autologous Serum 20% four times a day

Other Names:

Autologus serum low concentration

Active Comparator: Autologous Serum 50%

Treatment with Autologous Serum 50% for 2 months

Drug: Autologous Serum 50%

Instillation of 1 drop of Autologous Serum 50% four times a day

Other Names:

Autologus serum high concentration

Outcome Measures

Primary Outcome Measures

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

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.
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 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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