MedTrace Logo

Amniotic Membrane Treatment for Hyposecretory Dry Eye

NCT05598242 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2022-10-28

No results posted yet for this study

Summary

The goal of this randomized, active-controlled, parallel-group trial is to evaluate the clinical efficacy of amniotic membrane extract eye drops (AMEED) in reducing signs and symptoms of hyposecretory dry eye

Participants will receibed amniotic membrane extract eye drops 6 times daily and was evaluated at baseline day and day 30th.

Researchers will compare against autologous serum eye drops effects

Conditions

  • Dry Eye Syndromes
  • Sjogren Syndrome With Keratoconjunctivitis

Interventions

BIOLOGICAL

Amniotic membrane extract eye drops (AMEED)

Following a 2-week wash out period, patients were allocated randomly to receive AMEED, administered as 1 drop in each eye 6 times daily, respectively, for 30 days.

Sponsors & Collaborators

  • Hospital Nacional Profesor Alejandro Posadas

    lead OTHER

Principal Investigators

  • Emiliano F Ross, MD · assistant

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-01
Primary Completion
2019-09-01
Completion
2019-12-15

Countries

  • Argentina

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05598242 on ClinicalTrials.gov