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This is a randomized, double-masked, placebo-controlled study to determine the safety of pAF in patients who undergo PRK.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amniotic Fluid (AFED) | Active Comparator |
| |
| Saline Solution | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amniotic Fluid (AFED) | Biological | One drop (0.25 mL) of Amniotic Fluid Eye Drops (AFED) in each eye four times daily for seven days |
|
| 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 |
| 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. |
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Inclusion:
Exclusion:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moran Eye Center, University of Utah | Salt Lake City | Utah | 84132 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Saline Solution | Saline Solution: One drop (0.25 mL) of Saline Solution in each eye four times daily for seven days |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The population includes all subjects who provide informed consent and who are randomized into the trial and who have analyzable primary outcome data for at least one PRK-treated eye.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Saline Solution | Saline Solution: One drop (0.25 mL) of Saline Solution in each eye four times daily for seven days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Safety - Adverse Events Including Serious Adverse Events | Ocular adverse events using MedDRA and CTCAE and serious adverse events | Posted | Count of Participants | Participants | Up to 12 months after the last study dose |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intraocular pressure increased | Investigations | MedDRA (26.1) | Systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mark Mifflin, MD | University of Utah | 801-583-4152 | mark.mifflin@hsc.utah.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 1, 2021 | Nov 27, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 9, 2020 | Feb 14, 2024 | SAP_003.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 28, 2022 | Nov 27, 2023 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| Saline Solution | Other | One drop (0.25 mL) of Saline Solution in each eye four times daily for seven days |
|
| Post-operative days 1 - 8 |
| Uncorrected Visual Acuity | Ophthalmologic assessment to determine uncorrected 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 |
| Count of Participants Who Reported Oral Pain Medication Usage | Patient 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. | 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™. 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. | Post-operative months 1, 3, 6, and 12 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Current Smoker or exposed to secondhand smoke | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | days | Post-operative days 1 - 8 |
|
|
|
|
| Secondary | Uncorrected Visual Acuity | Ophthalmologic assessment to determine uncorrected visual acuity | Some patients missed one or more follow-up windows. We analyzed all available data. | Posted | Mean | Standard Deviation | LogMAR | Post-operative months 1, 3, 6, and 12 | eyes | eyes |
|
|
|
|
| Secondary | Pain in Each Eye | Patient reported pain using a visual analog scale (VAS) with 0 as no pain and 10 as worst pain | Posted | Median | Inter-Quartile Range | score on a scale | Post-operative days 1 - 8 |
|
|
|
|
| Secondary | Count of Participants Who Reported Oral Pain Medication Usage | Patient 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. | Posted | Count of Participants | Participants | Post-operative days 1 - 8 |
|
|
|
|
| Secondary | 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). | Subjects were analyzed for every follow-up that was collected. Some subject missed one or more follow-ups. | Posted | Count of Units | eyes | Post-operative months 1, 3, 6, and 12 | eyes | eyes |
|
|
|
|
| Secondary | Corneal Surface Regularity | 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. | Some patients missed one or more follow-up windows. We analyzed all available data. | Posted | Mean | Standard Deviation | Surface regularity index | Post-operative months 1, 3, 6, and 12 | eyes | eyes |
|
|
|
|
| 0 |
| 28 |
| 0 |
| 28 |
| 2 |
| 28 |
| EG001 | Saline Solution | Saline Solution: One drop (0.25 mL) of Saline Solution in each eye four times daily for seven days | 0 | 32 | 0 | 32 | 1 | 32 |
| Syncope | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
|
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| Month 3 |
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| Month 6 |
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| Month 12 |
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Mixed model analysis is used to account for correlation between eyes in the same participant. |
| 0.953 |
Significance of treatment effect at month 3. |
| Superiority |
| Mixed Models Analysis | Mixed model analysis is used to account for correlation between eyes in the same participant. | 0.841 | Significance of treatment effect at month 6. | Superiority |
| Mixed Models Analysis | Mixed model analysis is used to account for correlation between eyes in the same participant. | 0.137 | Significance of treatment effect at month 12. | Superiority |
|
| Month 3 |
|
|
| Month 6 |
|
|
| Month 12 |
|
|
Clustered version of the Wilcoxon test |
| 0.416 |
Significance of treatment effect at month 3. |
| Superiority |
| Wilcoxon (Mann-Whitney) | Clustered version of the Wilcoxon test | 0.890 | Significance of treatment effect at month 6. | Superiority |
| Wilcoxon (Mann-Whitney) | Clustered version of the Wilcoxon test | 0.192 | Significance of treatment effect at month 12. | Superiority |
|
| Month 3 |
|
|
| Month 6 |
|
|
| Month 12 |
|
|
Mixed model analysis is used to account for correlation between eyes in the same participant. |
| 0.528 |
Significance of treatment effect at month 3. |
| Superiority |
| Mixed Models Analysis | Mixed model analysis is used to account for correlation between eyes in the same participant. | 0.210 | Significance of treatment effect at month 6. | Superiority |
| Mixed Models Analysis | Mixed model analysis is used to account for correlation between eyes in the same participant. | 0.853 | Significance of treatment effect at month 12. | Superiority |
| A1D2 |
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| A1D3 |
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| A2D2 |
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| A2D1 |
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| A1D2 |
|
| A1D3 |
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| A2D2 |
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| A2D1 |
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| A1D2 |
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| A1D3 |
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| A2D2 |
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| A2D1 |
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