Trial Outcomes & Findings for Processed Amniotic Fluid (PAF) Drops After Photorefractive Keratectomy (PRK) (NCT NCT04281004)
NCT ID: NCT04281004
Last Updated: 2024-04-18
Results Overview
Ocular adverse events using MedDRA and CTCAE and serious adverse events
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
61 participants
Primary outcome timeframe
Up to 12 months after the last study dose
Results posted on
2024-04-18
Participant Flow
Unit of analysis: eyes
Participant milestones
| Measure |
Amniotic Fluid (AFED)
Amniotic Fluid (AFED): One drop (0.25 mL) of Amniotic Fluid Eye Drops (AFED) in each eye four times daily for seven days
|
Saline Solution
Saline Solution: One drop (0.25 mL) of Saline Solution in each eye four times daily for seven days
|
|---|---|---|
|
Overall Study
STARTED
|
29 58
|
32 64
|
|
Overall Study
COMPLETED
|
28 56
|
32 64
|
|
Overall Study
NOT COMPLETED
|
1 2
|
0 0
|
Reasons for withdrawal
| Measure |
Amniotic Fluid (AFED)
Amniotic Fluid (AFED): One drop (0.25 mL) of Amniotic Fluid Eye Drops (AFED) in each eye four times daily for seven days
|
Saline Solution
Saline Solution: One drop (0.25 mL) of Saline Solution in each eye four times daily for seven days
|
|---|---|---|
|
Overall Study
Physician Decision
|
1
|
0
|
Baseline Characteristics
Processed Amniotic Fluid (PAF) Drops After Photorefractive Keratectomy (PRK)
Baseline characteristics by cohort
| Measure |
Amniotic Fluid (AFED)
n=28 Participants
Amniotic Fluid (AFED): One drop (0.25 mL) of Amniotic Fluid Eye Drops (AFED) in each eye four times daily for seven days
|
Saline Solution
n=32 Participants
Saline Solution: One drop (0.25 mL) of Saline Solution in each eye four times daily for seven days
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
33.8 years
n=93 Participants
|
32.7 years
n=4 Participants
|
33.4 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=93 Participants
|
19 Participants
n=4 Participants
|
32 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
28 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 Participants
n=93 Participants
|
29 Participants
n=4 Participants
|
55 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=93 Participants
|
30 Participants
n=4 Participants
|
56 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=93 Participants
|
32 participants
n=4 Participants
|
60 participants
n=27 Participants
|
|
Current Smoker or exposed to secondhand smoke
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Up to 12 months after the last study doseOcular adverse events using MedDRA and CTCAE and serious adverse events
Outcome measures
| Measure |
Amniotic Fluid (AFED)
n=28 Participants
Amniotic Fluid (AFED): One drop (0.25 mL) of Amniotic Fluid Eye Drops (AFED) in each eye four times daily for seven days
|
Saline Solution
n=32 Participants
Saline Solution: One drop (0.25 mL) of Saline Solution in each eye four times daily for seven days
|
|---|---|---|
|
Safety - Adverse Events Including Serious Adverse Events
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Post-operative days 1 - 8Ophthalmologic 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.
Outcome measures
| Measure |
Amniotic Fluid (AFED)
n=28 Participants
Amniotic Fluid (AFED): One drop (0.25 mL) of Amniotic Fluid Eye Drops (AFED) in each eye four times daily for seven days
|
Saline Solution
n=32 Participants
Saline Solution: One drop (0.25 mL) of Saline Solution in each eye four times daily for seven days
|
|---|---|---|
|
Time to Complete Re-epithelization
|
5 days
Standard Deviation 0.6
|
5 days
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: Post-operative months 1, 3, 6, and 12Population: Some patients missed one or more follow-up windows. We analyzed all available data.
Ophthalmologic assessment to determine uncorrected visual acuity
Outcome measures
| Measure |
Amniotic Fluid (AFED)
n=54 eyes
Amniotic Fluid (AFED): One drop (0.25 mL) of Amniotic Fluid Eye Drops (AFED) in each eye four times daily for seven days
|
Saline Solution
n=62 eyes
Saline Solution: One drop (0.25 mL) of Saline Solution in each eye four times daily for seven days
|
|---|---|---|
|
Uncorrected Visual Acuity
Month 1
|
-0.03 LogMAR
Standard Deviation 0.103
|
0.04 LogMAR
Standard Deviation 0.123
|
|
Uncorrected Visual Acuity
Month 3
|
-0.06 LogMAR
Standard Deviation 0.097
|
-0.05 LogMAR
Standard Deviation 0.103
|
|
Uncorrected Visual Acuity
Month 6
|
-0.07 LogMAR
Standard Deviation 0.085
|
-0.06 LogMAR
Standard Deviation 0.091
|
|
Uncorrected Visual Acuity
Month 12
|
-0.09 LogMAR
Standard Deviation 0.058
|
-0.06 LogMAR
Standard Deviation 0.107
|
SECONDARY outcome
Timeframe: Post-operative days 1 - 8Patient reported pain using a visual analog scale (VAS) with 0 as no pain and 10 as worst pain
Outcome measures
| Measure |
Amniotic Fluid (AFED)
n=28 Participants
Amniotic Fluid (AFED): One drop (0.25 mL) of Amniotic Fluid Eye Drops (AFED) in each eye four times daily for seven days
|
Saline Solution
n=32 Participants
Saline Solution: One drop (0.25 mL) of Saline Solution in each eye four times daily for seven days
|
|---|---|---|
|
Pain in Each Eye
|
4 score on a scale
Interval 2.0 to 7.0
|
5 score on a scale
Interval 3.0 to 7.0
|
SECONDARY outcome
Timeframe: Post-operative days 1 - 8Patient 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.
Outcome measures
| Measure |
Amniotic Fluid (AFED)
n=28 Participants
Amniotic Fluid (AFED): One drop (0.25 mL) of Amniotic Fluid Eye Drops (AFED) in each eye four times daily for seven days
|
Saline Solution
n=32 Participants
Saline Solution: One drop (0.25 mL) of Saline Solution in each eye four times daily for seven days
|
|---|---|---|
|
Count of Participants Who Reported Oral Pain Medication Usage
|
26 Participants
|
31 Participants
|
SECONDARY outcome
Timeframe: Post-operative months 1, 3, 6, and 12Population: Subjects were analyzed for every follow-up that was collected. Some subject missed one or more follow-ups.
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).
Outcome measures
| Measure |
Amniotic Fluid (AFED)
n=54 eyes
Amniotic Fluid (AFED): One drop (0.25 mL) of Amniotic Fluid Eye Drops (AFED) in each eye four times daily for seven days
|
Saline Solution
n=62 eyes
Saline Solution: One drop (0.25 mL) of Saline Solution in each eye four times daily for seven days
|
|---|---|---|
|
Corneal Staining in Each Eye
Month 12 · A2D1
|
0 eyes
|
0 eyes
|
|
Corneal Staining in Each Eye
Month 1 · A0D0
|
33 eyes
|
42 eyes
|
|
Corneal Staining in Each Eye
Month 1 · A1D1
|
18 eyes
|
15 eyes
|
|
Corneal Staining in Each Eye
Month 1 · A1D2
|
1 eyes
|
3 eyes
|
|
Corneal Staining in Each Eye
Month 1 · A1D3
|
0 eyes
|
1 eyes
|
|
Corneal Staining in Each Eye
Month 1 · A2D2
|
2 eyes
|
1 eyes
|
|
Corneal Staining in Each Eye
Month 1 · A2D1
|
0 eyes
|
0 eyes
|
|
Corneal Staining in Each Eye
Month 3 · A0D0
|
45 eyes
|
46 eyes
|
|
Corneal Staining in Each Eye
Month 3 · A1D1
|
6 eyes
|
8 eyes
|
|
Corneal Staining in Each Eye
Month 3 · A1D2
|
0 eyes
|
2 eyes
|
|
Corneal Staining in Each Eye
Month 3 · A1D3
|
0 eyes
|
0 eyes
|
|
Corneal Staining in Each Eye
Month 3 · A2D2
|
0 eyes
|
2 eyes
|
|
Corneal Staining in Each Eye
Month 3 · A2D1
|
1 eyes
|
0 eyes
|
|
Corneal Staining in Each Eye
Month 6 · A0D0
|
46 eyes
|
52 eyes
|
|
Corneal Staining in Each Eye
Month 6 · A1D1
|
8 eyes
|
7 eyes
|
|
Corneal Staining in Each Eye
Month 6 · A1D2
|
0 eyes
|
0 eyes
|
|
Corneal Staining in Each Eye
Month 6 · A1D3
|
0 eyes
|
0 eyes
|
|
Corneal Staining in Each Eye
Month 6 · A2D2
|
0 eyes
|
1 eyes
|
|
Corneal Staining in Each Eye
Month 6 · A2D1
|
0 eyes
|
0 eyes
|
|
Corneal Staining in Each Eye
Month 12 · A0D0
|
47 eyes
|
43 eyes
|
|
Corneal Staining in Each Eye
Month 12 · A1D1
|
3 eyes
|
9 eyes
|
|
Corneal Staining in Each Eye
Month 12 · A1D2
|
0 eyes
|
0 eyes
|
|
Corneal Staining in Each Eye
Month 12 · A1D3
|
0 eyes
|
0 eyes
|
|
Corneal Staining in Each Eye
Month 12 · A2D2
|
0 eyes
|
0 eyes
|
SECONDARY outcome
Timeframe: Post-operative months 1, 3, 6, and 12Population: Some patients missed one or more follow-up windows. We analyzed all available data.
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.
Outcome measures
| Measure |
Amniotic Fluid (AFED)
n=56 eyes
Amniotic Fluid (AFED): One drop (0.25 mL) of Amniotic Fluid Eye Drops (AFED) in each eye four times daily for seven days
|
Saline Solution
n=64 eyes
Saline Solution: One drop (0.25 mL) of Saline Solution in each eye four times daily for seven days
|
|---|---|---|
|
Corneal Surface Regularity
Month 1
|
1.34 Surface regularity index
Standard Deviation 0.567
|
1.58 Surface regularity index
Standard Deviation 0.748
|
|
Corneal Surface Regularity
Month 3
|
1.11 Surface regularity index
Standard Deviation 0.616
|
1.07 Surface regularity index
Standard Deviation 0.407
|
|
Corneal Surface Regularity
Month 6
|
1.07 Surface regularity index
Standard Deviation 0.376
|
0.97 Surface regularity index
Standard Deviation 0.389
|
|
Corneal Surface Regularity
Month 12
|
1.03 Surface regularity index
Standard Deviation 0.459
|
1.05 Surface regularity index
Standard Deviation 0.661
|
Adverse Events
Amniotic Fluid (AFED)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Saline Solution
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Amniotic Fluid (AFED)
n=28 participants at risk
Amniotic Fluid (AFED): One drop (0.25 mL) of Amniotic Fluid Eye Drops (AFED) in each eye four times daily for seven days
|
Saline Solution
n=32 participants at risk
Saline Solution: One drop (0.25 mL) of Saline Solution in each eye four times daily for seven days
|
|---|---|---|
|
Investigations
Intraocular pressure increased
|
3.6%
1/28 • Number of events 1 • Randomization through last study visit (12 months after the last study dose), up to 56 weeks.
All deaths, Serious Adverse Events, and other ocular Adverse Events regardless of seriousness were reported.
|
3.1%
1/32 • Number of events 1 • Randomization through last study visit (12 months after the last study dose), up to 56 weeks.
All deaths, Serious Adverse Events, and other ocular Adverse Events regardless of seriousness were reported.
|
|
Nervous system disorders
Syncope
|
3.6%
1/28 • Number of events 1 • Randomization through last study visit (12 months after the last study dose), up to 56 weeks.
All deaths, Serious Adverse Events, and other ocular Adverse Events regardless of seriousness were reported.
|
0.00%
0/32 • Randomization through last study visit (12 months after the last study dose), up to 56 weeks.
All deaths, Serious Adverse Events, and other ocular Adverse Events regardless of seriousness were reported.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place