Photorefractive KeratectomyPhase 1/2NCT04281004
Processed Amniotic Fluid (PAF) Drops After Photorefractive Keratectomy (PRK)
A Phase 1/2 study testing Amniotic Fluid (AFED) and Saline Solution in people with Photorefractive Keratectomy, run by University of Utah at 1 site in United States.
Trial summary
This is a randomized, double-masked, placebo-controlled study to determine the safety of pAF in patients who undergo PRK. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Photorefractive Keratectomy
- What is being tested?
- Amniotic Fluid (AFED) and Saline Solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jul 2020to 16 Jan 2023
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Moran Eye Center, University of Utah
Salt Lake City, Utah, 84132
About this study
Official title: A Phase I/II Randomized, Double-Masked Placebo-Controlled Study For Determining The Safety Of Processed Amniotic Fluid (PAF) Drops After Photorefractive Keratectomy
This is a randomized, double-masked, placebo-controlled study to determine the safety of pAF in patients who undergo PRK.
Read the 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
- Conditions
- Photorefractive Keratectomy
- Being tested
- Amniotic Fluid (AFED), Saline Solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Amniotic Fluid (AFED) | Active comparator | Not described Receives: Biological: Amniotic Fluid (AFED) |
| Saline Solution | Placebo comparator | Not described Receives: Other: Saline Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety - Adverse Events Including Serious Adverse Events
Ocular adverse events using MedDRA and CTCAE and serious adverse events
Measured: Up to 12 months after the last study dose
Secondary outcomes (6)
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.
Measured: Post-operative days 1 - 8
Uncorrected Visual Acuity
Ophthalmologic assessment to determine uncorrected visual acuity
Measured: 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
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Post-operative months 1, 3, 6, and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2020
- Study start10 Jul 2020
- Primary completion16 Jan 2023
- Study completion16 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Photorefractive KeratectomyStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark Mifflin, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04281004
- Sponsor's protocol ID
- 99569
- Status last verified
- Apr 2024
- First submitted
- 19 Feb 2020
- Last updated
- 18 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Randomized, Double-Masked Placebo-Controlled Study For Determining The Safety Of Processed Amniotic Fluid (PAF) Drops After Photorefractive Keratectomy
- ClinicalTrials.gov ID
- NCT04281004
- Acronym / sponsor ID
- 99569
- Conditions
- Photorefractive Keratectomy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 10 Jul 2020 (actual)
- Primary completion
- 16 Jan 2023 (actual)
- Study completion
- 16 Jan 2023 (actual)
- First posted
- 21 Feb 2020 (actual)
- Results
- Posted 18 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amniotic Fluid (AFED) | Active comparator | Biological: Amniotic Fluid (AFED) |
| Saline Solution | Placebo comparator | Other: Saline Solution |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amniotic Fluid (AFED)One drop (0.25 mL) of Amniotic Fluid Eye Drops (AFED) in each eye four times daily for seven days | Biological | Amniotic Fluid (AFED) |
| Saline SolutionOne drop (0.25 mL) of Saline Solution in each eye four times daily for seven days | Other | Saline Solution |
Primary outcome
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
6 secondary outcomes
Time to Complete Re-epithelization
Time frame: Post-operative days 1 - 8
Uncorrected Visual Acuity
Time frame: Post-operative months 1, 3, 6, and 12
Pain in Each Eye
Time frame: Post-operative days 1 - 8
Count of Participants Who Reported Oral Pain Medication Usage
Time frame: Post-operative days 1 - 8
Corneal Staining in Each Eye
Time frame: Post-operative months 1, 3, 6, and 12
Corneal Surface Regularity
Time frame: Post-operative months 1, 3, 6, and 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Amniotic Fluid (AFED) and Saline Solution in people with Photorefractive Keratectomy, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety - Adverse Events Including Serious Adverse Events (time frame: Up to 12 months after the last study dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2024.