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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE September 24, 2014
First Posted Date  ICMJE October 7, 2014
Last Update Posted Date October 7, 2014
Study Start Date  ICMJE November 2014
Estimated Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 2, 2014)
  • Corneal Staining Change [ Time Frame: from baseline at 90 days ]
  • Shirmer test Change [ Time Frame: from baseline at 90 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 2, 2014)
  • Ocular Surface Disease Index (OSDI ) Change [ Time Frame: from baseline at 3 months ]
  • Treatment compliance [ Time Frame: 3 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Platelet -Rich Plasma (PRP) Injection for the Treatment of Severe Dry Eye
Official Title  ICMJE Platelet -Rich Plasma (PRP) Injection for the Treatment of Severe Dry Eye
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Dry Eye
  • Sjogren Syndrome
Intervention  ICMJE
  • Drug: PRP injection
  • 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
Study Arms  ICMJE
  • Experimental: Platelet -Rich Plasma (PRP)
    15 patients with diagnosis of severe dry eye will receive PRP injection at day 0, 30,60 and 90
    Intervention: 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
    Intervention: Drug: Standard care Hyaluronic acid eye drops
Publications * Avila MY, Igua AM, Mora AM. Randomised, prospective clinical trial of platelet-rich plasma injection in the management of severe dry eye. Br J Ophthalmol. 2018 Jul 3. pii: bjophthalmol-2018-312072. doi: 10.1136/bjophthalmol-2018-312072. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 2, 2014)
30
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02257957
Other Study ID Numbers  ICMJE plasmadry10
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Universidad Nacional de Colombia
Study Sponsor  ICMJE Universidad Nacional de Colombia
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Universidad Nacional de Colombia
Verification Date October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP