NCT04281004

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

Completed Phase 1, PHASE2 Results posted Last updated 18 April 2024

What this trial tests

Phase 1, PHASE2 trial testing Amniotic Fluid (AFED) in Photorefractive Keratectomy in 61 participants. Completed in 16 January 2023.

Timeline

10 July 2020

Primary endpoint
16 January 2023

16 January 2023

Quick facts

Lead sponsor	University of Utah
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	61
Start date	10 July 2020
Primary completion	16 January 2023
Estimated completion	16 January 2023
Sites	1 location across United States

Drugs / interventions tested

• Amniotic Fluid (AFED) — full drug profile →
• Saline Solution

Conditions studied

• Photorefractive Keratectomy — all drugs for Photorefractive Keratectomy →

Sponsor

University of Utah

Who can join

21 and older, any sex, with Photorefractive Keratectomy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Safety - Adverse Events Including Serious Adverse Events Primary · Up to 12 months after the last study dose

Ocular adverse events using MedDRA and CTCAE and serious adverse events

Group	Value	95% CI
Amniotic Fluid (AFED)	1
Saline Solution	1

Time to Complete Re-epithelization Secondary · Post-operative days 1 - 8

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.

Group	Value	95% CI
Amniotic Fluid (AFED)	5	± 0.6
Saline Solution	5	± 0.5

Uncorrected Visual Acuity Secondary · Post-operative months 1, 3, 6, and 12

Ophthalmologic assessment to determine uncorrected visual acuity

Month 1

Group	Value	95% CI
Amniotic Fluid (AFED)	-0.03	± 0.103
Saline Solution	0.04	± 0.123

Month 3

Group	Value	95% CI
Amniotic Fluid (AFED)	-0.06	± 0.097
Saline Solution	-0.05	± 0.103

Month 6

Group	Value	95% CI
Amniotic Fluid (AFED)	-0.07	± 0.085
Saline Solution	-0.06	± 0.091

Month 12

Group	Value	95% CI
Amniotic Fluid (AFED)	-0.09	± 0.058
Saline Solution	-0.06	± 0.107

Pain in Each Eye Secondary · Post-operative days 1 - 8

Patient reported pain using a visual analog scale (VAS) with 0 as no pain and 10 as worst pain

Group	Value	95% CI
Amniotic Fluid (AFED)	4	2 – 7
Saline Solution	5	3 – 7

Count of Participants Who Reported Oral Pain Medication Usage Secondary · Post-operative days 1 - 8

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.

Group	Value	95% CI
Amniotic Fluid (AFED)	26
Saline Solution	31

Corneal Staining in Each Eye Secondary · Post-operative months 1, 3, 6, and 12

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).

Month 1

Group	Value	95% CI
Amniotic Fluid (AFED)	33
Saline Solution	42
Amniotic Fluid (AFED)	18
Saline Solution	15
Amniotic Fluid (AFED)	1
Saline Solution	3
Amniotic Fluid (AFED)	0
Saline Solution	1

Month 3

Group	Value	95% CI
Amniotic Fluid (AFED)	45
Saline Solution	46
Amniotic Fluid (AFED)	6
Saline Solution	8
Amniotic Fluid (AFED)	0
Saline Solution	2
Amniotic Fluid (AFED)	0
Saline Solution	0

Month 6

Group	Value	95% CI
Amniotic Fluid (AFED)	46
Saline Solution	52
Amniotic Fluid (AFED)	8
Saline Solution	7
Amniotic Fluid (AFED)	0
Saline Solution	0
Amniotic Fluid (AFED)	0
Saline Solution	0

Month 12

Group	Value	95% CI
Amniotic Fluid (AFED)	47
Saline Solution	43
Amniotic Fluid (AFED)	3
Saline Solution	9
Amniotic Fluid (AFED)	0
Saline Solution	0
Amniotic Fluid (AFED)	0
Saline Solution	0

Corneal Surface Regularity Secondary · Post-operative months 1, 3, 6, and 12

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.

Month 1

Group	Value	95% CI
Amniotic Fluid (AFED)	1.34	± 0.567
Saline Solution	1.58	± 0.748

Month 3

Group	Value	95% CI
Amniotic Fluid (AFED)	1.11	± 0.616
Saline Solution	1.07	± 0.407

Month 6

Group	Value	95% CI
Amniotic Fluid (AFED)	1.07	± 0.376
Saline Solution	0.97	± 0.389

Month 12

Group	Value	95% CI
Amniotic Fluid (AFED)	1.03	± 0.459
Saline Solution	1.05	± 0.661

Adverse events — posted to ClinicalTrials.gov

Time frame: Randomization through last study visit (12 months after the last study dose), up to 56 weeks.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Amniotic Fluid (AFED)

Serious: 0/28 (0%)

Deaths: 0/28

Saline Solution

Serious: 0/32 (0%)

Deaths: 0/32

Other adverse events (2 terms — click to expand)

Reaction	System	Amniotic Fluid (AFED)	Saline Solution
Intraocular pressure increased	Investigations	—	—
Syncope	Nervous system disorders	—	—

Data from ClinicalTrials.gov NCT04281004 adverse events section.

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Cell-Free Amniotic Fluid and Regenerative Medicine: Current Applications and Future Opportunities.
   Bowen CM, Ditmars FS, Gupta A, Reems JA, et al · · 2022 · cited 18× · PMID 36428527 · DOI 10.3390/biomedicines10112960