At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 61 enrolled
Drug / intervention
Amniotic Fluid (AFED) +1 morebiological
Likely dose
Amniotic Fluid (AFED) 0.25 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase I/II Randomized, Double-Masked Placebo-Controlled Study For Determining The Safety Of Processed Amniotic Fluid (PAF) Drops After Photorefractive Keratectomy
In Brief
A Phase 2 clinical trial evaluating Amniotic Fluid (AFED) and Saline Solution for Photorefractive Keratectomy. Completed, enrolled 61 participants across 1 site.
Detailed Summary
This is a randomized, double-masked, placebo-controlled study to determine the safety of pAF in patients who undergo PRK.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPhotorefractive Keratectomy
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2020202120222023202420252026
First PostedFeb 2020
Enrollment StartJul 2020
Primary CompletionJan 2023
TodayJul 2026
First PostedFeb 21, 2020
Enrollment StartJul 10, 2020
Primary CompletionJan 16, 2023
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 6.4 years ago
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
Saline Solutionother
One drop (0.25 mL) of Saline Solution in each eye four times daily for seven days