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Processed Amniotic Fluid (PAF) Drops After Photorefractive Keratectomy (PRK)

NCT04281004 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2024-04-18

Study results available
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Summary

This is a randomized, double-masked, placebo-controlled study to determine the safety of pAF in patients who undergo PRK.

Conditions

  • Photorefractive Keratectomy

Interventions

BIOLOGICAL

Amniotic Fluid (AFED)

One drop (0.25 mL) of Amniotic Fluid Eye Drops (AFED) in each eye four times daily for seven days

OTHER

Saline Solution

One drop (0.25 mL) of Saline Solution in each eye four times daily for seven days

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-10
Primary Completion
2023-01-16
Completion
2023-01-16
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT04281004 on ClinicalTrials.gov