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

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ClinicalTrials.gov Identifier: NCT02257957
Recruitment Status : Unknown
Verified October 2014 by Universidad Nacional de Colombia.
Recruitment status was:  Not yet recruiting
First Posted : October 7, 2014
Last Update Posted : October 7, 2014
Sponsor:
Information provided by (Responsible Party):
Universidad Nacional de Colombia

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Dry Eye Sjogren Syndrome Drug: PRP injection Drug: Standard care Hyaluronic acid eye drops Phase 3

Detailed Description:
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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Platelet -Rich Plasma (PRP) Injection for the Treatment of Severe Dry Eye
Study Start Date : November 2014
Estimated Primary Completion Date : September 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Platelet -Rich Plasma (PRP)
15 patients with diagnosis of severe dry eye will receive PRP injection at day 0, 30,60 and 90
Drug: PRP injection
Active Comparator: 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
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




Primary Outcome Measures :
  1. Corneal Staining Change [ Time Frame: from baseline at 90 days ]
  2. Shirmer test Change [ Time Frame: from baseline at 90 days ]

Secondary Outcome Measures :
  1. Ocular Surface Disease Index (OSDI ) Change [ Time Frame: from baseline at 3 months ]
  2. Treatment compliance [ Time Frame: 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Universidad Nacional de Colombia
ClinicalTrials.gov Identifier: NCT02257957     History of Changes
Other Study ID Numbers: plasmadry10
First Posted: October 7, 2014    Key Record Dates
Last Update Posted: October 7, 2014
Last Verified: October 2014

Additional relevant MeSH terms:
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Keratoconjunctivitis Sicca
Dry Eye Syndromes
Eye Diseases
Ophthalmic Solutions
Sjogren's Syndrome
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Arthritis, Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Xerostomia
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Hyaluronic Acid
Pharmaceutical Solutions
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents