Phase 3
N=30
Platelet -Rich Plasma (PRP) Injection for the Treatment of Severe Dry Eye
Dry Eye · Sjogren Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT02257957 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Aug 2021
Primary outcome: Primary: Change From Baseline in Ocular Surface Staining — 1.2; 2.4 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- PRP injection (Drug); Standard care Hyaluronic acid eye drops (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Universidad Nacional de Colombia
- Primary completion
- Sep 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Ocular Surface Staining |
1.2; 2.4 | — |
| PRIMARY Change From Baseline in Shirmer Test |
9.2; 5.3 | — |
| SECONDARY Change From Baseline in Ocular Surface Disease Index (OSDI) |
34; 55 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02257957). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.