A Phase I/II Randomized, Double-Masked Placebo-Controlled Study For Determining The Safety Of Processed Amniotic Fluid (PAF) Drops After Photorefractive Keratectomy
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- University of Utah
- Enrollment
- 61
- Locations
- 1
- Primary Endpoint
- Safety - Adverse Events Including Serious Adverse Events
Study Overview
Brief Summary
This is a randomized, double-masked, placebo-controlled study to determine the safety of pAF in patients who undergo PRK.
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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.
Arms & Interventions
Saline Solution
Intervention: Saline Solution (Other)
Amniotic Fluid (AFED)
Intervention: Amniotic Fluid (AFED) (Biological)
Outcomes
Primary Outcomes
Safety - Adverse Events Including Serious Adverse Events
Time Frame: Up to 12 months after the last study dose
Ocular adverse events using MedDRA and CTCAE and serious adverse events
Secondary Outcomes
- 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)
- 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)
- Corneal Surface Regularity(Post-operative months 1, 3, 6, and 12)
Investigators
Mark Mifflin
MD
University of Utah