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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-12

Study Completion Date

2018-11-19

Brief Summary

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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

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Autologous Serum 20%

Treatment with Autologous Serum 20% for 2 months

Group Type ACTIVE_COMPARATOR

Autologous Serum 20%

Intervention Type DRUG

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

Autologous Serum 50%

Treatment with Autologous Serum 50% for 2 months

Group Type ACTIVE_COMPARATOR

Autologous Serum 50%

Intervention Type DRUG

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

Interventions

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Autologous Serum 20%

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

Intervention Type DRUG

Autologous Serum 50%

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

Intervention Type DRUG

Other Intervention Names

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Autologus serum low concentration Autologus serum high concentration

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No