CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 30 enrolled
Drug / intervention
PRP injection +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02257957
NCT02257957Phase 3Completed
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Platelet -Rich Plasma (PRP) Injection for the Treatment of Severe Dry Eye

Universidad Nacional de Colombia·interventional·Posted Oct 7, 2014·Updated Aug 24, 2021

In Brief

A Phase 3 clinical trial evaluating PRP injection and Standard care Hyaluronic acid eye drops for Dry Eye and Sjogren Syndrome. Completed, enrolled 30 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDry Eye, Sjogren Syndrome
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedOct 7, 2014
Enrollment StartNov 30, 2014
Primary CompletionSep 30, 2015
Study CompletionApr 20, 2016
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 11.7 years ago

Interventions

PRP injectiondrug

Standard care Hyaluronic acid eye dropsdrug

: 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