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

NCT02257957 | Completed Phase 3 Results DMC

• 1 other identifier: plasmadry10
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dry Eye; Sjogren Syndrome

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in Ocular Surface Staining

  Surface damage to the exposed eye, assessed by staining, is graded against standard charts. According to the Oxford grade panel (Oxford Scale), the staining was graded and was classified from grade 0 to grade V (0 to 5 score). The minimum value of this scale was 0, which indicating absent surface damage, and the maximum value was 5, which meaning severe surface damages.

  90 days

• Change From Baseline in Shirmer Test

  The Schirmer test I (performed without anaesthesia) was completed before any drops were instilled in the eye. Standardised Schirmer strips (Biotech Vision Care, Gandhinagar, India) were bent at the notch and placed carefully over the lower lid margin as far as possible towards the temporal angle of the lids. The patient was instructed to keep his/her eyelids closed during the test. The strips remained in place for 5 min. After 5 min, the amount of moisture in each strip was measured using a millimetre scale

  90 days

Secondary Outcomes (1)

• Change From Baseline in Ocular Surface Disease Index (OSDI)

  90 days

Study Arms (2)

Platelet -Rich Plasma (PRP)

EXPERIMENTAL

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

Drug: PRP injection

Standard Care

ACTIVE COMPARATOR

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

Interventions

PRP injection DRUG

Platelet -Rich Plasma (PRP)

Standard care Hyaluronic acid eye drops 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

Standard Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad Nacional de Colombia: lead

Related Publications (1)

• 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:bjophthalmol-2018-312072. doi: 10.1136/bjophthalmol-2018-312072. Online ahead of print.

  PMID: 29970389 DERIVED

MeSH Terms

Conditions

Dry Eye Syndromes; Sjogren's Syndrome

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Dr Marcel Y Avila
• Organization: Universidad Nacional de Colombia

myavilac@unal.edu.co

+5713165000

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2014
• First Posted: October 7, 2014
• Study Start: November 30, 2014
• Primary Completion: September 30, 2015
• Study Completion: April 20, 2016
• Last Updated: August 24, 2021
• Results First Posted: August 24, 2021

Record last verified: 2021-07