Platelet -Rich Plasma (PRP) Injection for the Treatment of Severe Dry Eye

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2016-04-20

Brief Summary

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Dry eye is a chronic condition that decreases function and affect visual function with severe discapacity until now treatments are based in artificial eye drops. Platelet rich plasma has emerged as a strategy for cellular restoration, the purpose of this study is to evaluate their effects in lacrimal production and safety of this intervention in patients with severe dry eye.

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Detailed Description

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Dry eye is a chronic condition that decreases function and affect visual function with severe discapacity until now treatments are based in artificial eye drops. Platelet rich plasma has emerged as a strategy for cellular restoration, the purpose of this study is to evaluate their effects in lacrimal production and safety of this intervention in patients with severe dry eye.

Conditions

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Dry Eye Sjogren Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Platelet -Rich Plasma (PRP)

15 patients with diagnosis of severe dry eye will receive PRP injection at day 0, 30,60 and 90

Group Type EXPERIMENTAL

PRP injection

Intervention Type DRUG

Standard Care

15 patients with diagnosis of severe dry eye will receive standard of care treatment and will be revised at day 0, 30,60,90

Group Type ACTIVE_COMPARATOR

Standard care Hyaluronic acid eye drops

Intervention Type DRUG

: 15 patients with diagnosis of severe dry eye will receive standard of care treatment ( Hyaluronic acid eye drops 5 times per day). Objective measurements as corneal staining, Shirmer , BUT, and VA, will be determinate as subjective measurements as OSDI and treatment compliance will be evaluated at day 0-30,60 and 90

Interventions

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PRP injection

Intervention Type DRUG

Standard care Hyaluronic acid eye drops

: 15 patients with diagnosis of severe dry eye will receive standard of care treatment ( Hyaluronic acid eye drops 5 times per day). Objective measurements as corneal staining, Shirmer , BUT, and VA, will be determinate as subjective measurements as OSDI and treatment compliance will be evaluated at day 0-30,60 and 90

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* • Patients with symptomatic Dry eye

* Shirmer ≤10 mm in 5 min
* BUT ≤10 seconds
* Corneal staining ≥3
* Age range: 18 years and older.
* Both genders and all ethnic groups comparable with the local community.
* Able to understand and willing to sign a written informed consent
* Able and willing to cooperate with the investigational plan.
* Able and willing to complete all mandatory follow-up visits.

Exclusion Criteria

* • Patients who are currently engaged in another clinical trial, unwilling or unable to give consent, to accept randomization, or to return for scheduled visits.

* Children under 18.
* Pregnant women or expecting to be pregnant during the study.
* Systemic immune deficient conditions such as AIDS or under systemic immunosuppressant.
* Concomitant use of systemic antibiotics or steroids.
* Contact lens wear
* Active ocular infection or allergy
* Unable to close eyes or uncontrolled blinking

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No