Phase 3
Completed N=30
Platelet -Rich Plasma (PRP) Injection for the Treatment of Severe Dry Eye
Source: ClinicalTrials.gov NCT02257957 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Aug 2021
Primary outcomePrimary: Change From Baseline in Ocular Surface Staining — 1.2; 2.4 score on a scale
◆ Published Evidence
Established
48citations · ~6 / year
Randomised, prospective clinical trial of platelet-rich plasma injection in the management of severe dry eye.
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.
Linked Publications
-
Randomised, prospective clinical trial of platelet-rich plasma injection in the management of severe dry eye.
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 | — |
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) and the linked publication. 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. Informational only — not medical advice.