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

A Phase I/II Randomized, Double-Masked Placebo-Controlled Study For Determining The Safety Of Processed Amniotic Fluid (PAF) Drops After Photorefractive Keratectomy

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

Study Overview

• Status: Completed
• Conditions: Photorefractive Keratectomy
• Intervention / Treatment: Biological: Amniotic Fluid (AFED); Other: Saline Solution

Detailed Description

Photorefractive Keratectomy (PRK) is a common elective surgery used to correct refractive errors. We propose that amniotic fluid drops may be beneficial in promoting ocular surface healing following PRK. Purified amniotic fluid (pAF) contains anti-inflammatory, anti-microbial and regenerative factors similar to solid amniotic membrane. Individual patients will be randomized to one of two post-operative drop regimens, control eyes that will receive placebo saline solution (NaCl 0.9%, Baxter Medical), and study eyes that will receive pAF four times daily for seven days.

This is a randomized, double-masked, placebo-controlled study to determine

• the safety of pAF in patients who undergo PRK
• if pAF hastens re-epithelialization following PRK compared to placebo
• if pAF reduces post-operative pain following PRK compared to placebo
• if pAF affects visual outcome following PRK compared to placebo
• if pAF affects ocular surface staining and corneal regularity following PRK compared to placebo

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • Moran Eye Center, University of Utah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion:

1. Patients aged 21 years and older.
2. Patients undergoing PRK for visual correction in both eyes.
3. Willing and able to give consent for study participation and comply with study procedures, including follow-up visits.

Exclusion:

1. Patients with any active eye disease, including keratoconus or any other ectactic disorders.
2. Patients with documented uncontrolled diabetes.
3. Patients with severe dry eye as measured by corneal staining.
4. Patients with calculated PRK treatment resulting in residual stromal bed <300 um.
5. Patients who have had previous eye surgery or refractive laser procedures.
6. Patients with any active collagen vascular disease.
7. Patients who do not have potential of 20/20 or better best corrected vision in each eye.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Amniotic Fluid (AFED)	Biological: Amniotic Fluid (AFED); One drop (0.25 mL) of Amniotic Fluid Eye Drops (AFED) in each eye four times daily for seven days
Placebo Comparator: Saline Solution	Other: Saline Solution; One drop (0.25 mL) of Saline Solution in each eye four times daily for seven days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety - Adverse Events Including Serious Adverse Events	Ocular adverse events using MedDRA and CTCAE and serious adverse events	Up to 12 months after the last study dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Complete Re-epithelization	Ophthalmologic assessment to determine re-epithelialization. Dimensions of the epithelial defects will be directly measured using slit lamp bio-microscopy. The baseline epithelial defect will be measured by surgeons on Day 1 at the time of surgery. A vertical and horizontal measure of defect in mm will be performed, and defect area calculated. A complete re-epithelization (absence of a defect) is defined when the measures equal zero.	Post-operative days 1 - 8
Uncorrected Visual Acuity	Ophthalmologic assessment to determine uncorrected visual acuity	Post-operative months 1, 3, 6, and 12
Pain in Each Eye	Patient reported pain using a visual analog scale (VAS) with 0 as no pain and 10 as worst pain	Post-operative days 1 - 8
Count of Participants Who Reported Oral Pain Medication Usage	Patient reported oral pain medication usage in the first seven days of post-surgical follow-up (yes/no), where yes corresponds to any use of oral pain medication.	Post-operative days 1 - 8
Corneal Staining in Each Eye	Ocular surface staining to determine ocular dryness using an area density index with 16 index options. A0D0 equals no dry eye to A3D3 equals most severe dryness (A=area and D=density).	Post-operative months 1, 3, 6, and 12
Corneal Surface Regularity	Surface Regularity Index (SRI) obtained via Zeiss Atlas 9000 Corneal Topography™. SRI is a measure of central and paracentral corneal irregularity. A lower SRI suggests more regularity of the anterior surface of the central cornea. Lower values are considered better. The minimum value is 0 and no maximum. And, a value less than 1.55 is considered normal.	Post-operative months 1, 3, 6, and 12

Collaborators and Investigators

• Sponsor: University of Utah

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2020
• Primary Completion (Actual): January 16, 2023
• Study Completion (Actual): January 16, 2023

Study Registration Dates

• First Submitted: February 19, 2020
• First Submitted That Met QC Criteria: February 19, 2020
• First Posted (Actual): February 21, 2020

Study Record Updates

• Last Update Posted (Actual): April 18, 2024
• Last Update Submitted That Met QC Criteria: April 17, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 99569

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No