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

NCT04281004 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: 99569
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Photorefractive Keratectomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Time to Complete Re-epithelization

  Post-operative days 1 - 8

• Uncorrected Visual Acuity

  Post-operative months 1, 3, 6, and 12

• Pain in Each Eye

  Post-operative days 1 - 8

• Count of Participants Who Reported Oral Pain Medication Usage

  Post-operative days 1 - 8

• Corneal Staining in Each Eye

  Post-operative months 1, 3, 6, and 12

Study Arms (2)

Amniotic Fluid (AFED)

ACTIVE COMPARATOR

Biological: Amniotic Fluid (AFED)

Saline Solution

PLACEBO COMPARATOR

Other: Saline Solution

Interventions

Amniotic Fluid (AFED) BIOLOGICAL

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

Amniotic Fluid (AFED)

Saline Solution OTHER

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

Saline Solution

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

Moran Eye Center, University of Utah

Salt Lake City, Utah, 84132, United States

Location

MeSH Terms

Interventions

Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Limitations and Caveats

The limitations of this study include small sample size and limited duration for follow-up. A larger sample size may reveal whether pAF has a protective effect against haze formation, as haze after PRK is rare. Longer duration of follow-up can reveal whether it influences final visual acuity outcomes or late haze formation.

Results Point of Contact

• Title: Mark Mifflin, MD
• Organization: University of Utah

mark.mifflin@hsc.utah.edu

801-583-4152

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 19, 2020
• First Posted: February 21, 2020
• Study Start: July 10, 2020
• Primary Completion: January 16, 2023
• Study Completion: January 16, 2023
• Last Updated: April 18, 2024
• Results First Posted: April 18, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)