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

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

Detailed Description
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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

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

Conditions
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Photorefractive Keratectomy

Intervention / Treatment
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* Biological: Amniotic Fluid (AFED)
* Other: Saline Solution


Participation Criteria
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Eligibility Criteria
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Inclusion: 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. Exclusion: 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 bestcorrected vision in each eye.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 day 8, and months 1, 3, 6, and 12 | 
| Manifest refraction and best-corrected visual acuity | Ophthalmologic assessment to determine manifest refraction and best-corrected 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 | 
| Timing and frequency of use of rescue pain medication | Patient reported oral pain medication usage | 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™ | Post-operative months 1, 3, 6, and 12 |