MyopiaPhase 4NCT05733741
Preservative-free Topical Anesthetics for Post-PRK Pain
A Phase 4 study testing Preservative-free Benoxinate hydrochloride 0.4% (Benoxidia unit-dose vials [UD], Orchidia pharmaceutical Ind., Egypt) and Preservative-free Sodium hyaluronate 0.2% (Polyfresh unit-dose vials [UD], Orchidia pharmaceutical Ind., Egypt). in people with Myopia, run by Assiut University at 1 site in Egypt.
Trial summary
The goal of this interventional comparative study is to assess the efficacy and safety of a novel regimen of preservative-free unit-dose topical anesthetics for controlling early postoperative pain following single-step transepithelial PRK surgery. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- Preservative-free Benoxinate hydrochloride 0.4% (Benoxidia unit-dose vials [UD], Orchidia pharmaceutical Ind., Egypt) and Preservative-free Sodium hyaluronate 0.2% (Polyfresh unit-dose vials [UD], Orchidia pharmaceutical Ind., Egypt).
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Jan 2023to 15 Apr 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who are candidate for PRK surgery with
- Myopia up to - 6 diopters or myopic astigmatism up to - 4 diopters.
- Corneal thinnest pachymetry of 500 µm
- Residual stromal bed more than 350 µm after epithelial ablation.
Who cannot join
- Patients with
- Corneal scars or dry eye disease,
- Past ocular surgery,
- History of contact lens wear,
- Systemic diseases such as diabetes mellitus and autoimmune diseases,
- History of oral analgesics abuse.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preservative-free Topical Anesthetics for the Management of Postoperative Pain Following Photorefractive Keratectomy
The goal of this interventional comparative study is to assess the efficacy and safety of a novel regimen of preservative-free unit-dose topical anesthetics for controlling early postoperative pain following single-step transepithelial PRK surgery.
The main research questions to answer are:
Read more
- Question 1: Are topical anesthetics effective in reducing post-PRK pain?
- Question 2: Are short-term topical anesthetics toxic to the cornea?
- Question 3: How to prevent abuse of topical anesthetics by patients at home?
Participants were planned to undergo a bilateral single-step transepithelial PRK surgery to correct their refractive errors and received a standard post-PRK treatment regimen for both eyes. Additionally, one eye was offered a preservative-free topical anesthetic as an experimental group and the other eye was offered a preservative-free artificial tear as a control group.
Read the detailed description
Photorefractive keratectomy (PRK) is a well-established surface ablation procedure for correction of refractive errors which involves the removal of corneal epithelium in a large diameter usually more than 6 mm followed by stromal ablation.
Early postoperative pain within the first few days after surgery is one of the commonest complications reported after PRK. The classic postoperative treatment includes the prescription of topical antibiotics and frequent preservative-free lubricants to accelerate epithelial healing.
The current treatment regimens also includes topical steroids, topical non-steroidal anti-inflammatory drugs (NSAID) and oral NSAID to reduce inflammation and post-PRK pain.
Earlier studies suggested that topical anesthetics in diluted concentrations and fractional doses didn't delay corneal epithelial regeneration after PRK but their use didn't gain popularity because of problems with topical formulation, stability and preservation.
- Conditions
- Myopia
- Being tested
- Preservative-free Benoxinate hydrochloride 0.4% (Benoxidia unit-dose vials [UD], Orchidia pharmaceutical Ind., Egypt), Preservative-free Sodium hyaluronate 0.2% (Polyfresh unit-dose vials [UD], Orchidia pharmaceutical Ind., Egypt).
- Keywords
- Post-PRK pain, Preservative-free topical anesthetics, Single-step PRK
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preservative-free Benoxinate hydrochloride 0.4% (Benoxidia unit-dose vials [UD], Orchidia pharmaceutical Ind., Egypt)Drug
For each patient, one eye was treated with preservative-free Benoxinate hydrochloride 0.4%.
The prescribed regimen comprises of the instillation of one drop immediately, 2, 4, 6 and 8 hours after the end of surgery.
Every patient was given 5 UD vials only of preservative-free Benoxinate hydrochloride 0.4% at each follow up visit for the next postoperative day usage administered 5 times daily (every 3 hours while awake) for the first 3 postoperative days giving clear instructions to immediately discard the vial after single use.
Preservative-free Sodium hyaluronate 0.2% (Polyfresh unit-dose vials [UD], Orchidia pharmaceutical Ind., Egypt).Drug
The other eye was treated with preservative-free Sodium hyaluronate 0.2%. The prescribed regimen comprises of the instillation of one drop immediately, 2, 4, 6 and 8 hours after the end of surgery.
Every patient was given 5 UD vials only of preservative-free Sodium hyaluronate 0.2% at each follow up visit for the next postoperative day usage administered 5 times daily (every 3 hours while awake) for the first 3 postoperative days giving clear instructions to immediately discard the vial after single use.
| Study group | Role | What they receive |
|---|---|---|
| Preservative-free topical anesthetics group | Experimental | Patients in this group had the standard post-PRK treatment regimen in addition to the prescription of preservative-free topical anesthetics for pain control following single-step transepithelial PRK surgery in one eye. Receives: Drug: Preservative-free Benoxinate hydrochloride 0.4% (Benoxidia unit-dose vials [UD], Orchidia pharmaceutical Ind., Egypt) |
| Preservative-free artificial tears group | Placebo comparator | Patients in this group had the standard post-PRK treatment regimen in addition to the prescription of preservative-free artificial tears as a placebo following single-step transepithelial PRK surgery in the other eye. Receives: Drug: Preservative-free Sodium hyaluronate 0.2% (Polyfresh unit-dose vials [UD], Orchidia pharmaceutical Ind., Egypt). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain score on the verbal rating scale (VRS)
The doctor asks the patient to choose the word that best describes his/her pain and then gives it a score from zero to 4 (Zero for no pain, 1 for mild pain, 2 for moderate pain, 3 for severe pain and 4 for unbearable pain).
Measured: 1 week
Postoperative pain score on the visual analogue scale (VAS)
The patient is asked to rate his/her pain by choosing a number on a scale from zero to 10 considering zero as no pain and 10 as worst possible pain.
Measured: 1 week
Secondary outcomes (2)
Corneal epithelial healing duration
Time for the corneal epithelium to heal reported in days after PRK surgery
Measured: 1 week
Endothelial cell density (ECD)
Specular microscopy was used to assess endothelial cell count before and after PRK surgery
Measured: from preoperative to 1 month postoperative.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2023
- Study start30 Jan 2023
- Primary completion15 Apr 2023
- Study completion15 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MyopiaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Abdel-Radi, Assiut University
- Investigators
- Mahmoud Abdel-Radi, MD, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05733741
- Sponsor's protocol ID
- PFTAPRK
- Status last verified
- May 2023
- First submitted
- 30 Jan 2023
- Last updated
- 24 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Steigleman WA, Rose-Nussbaumer J, Al-Mohtaseb Z, Santhiago MR, Lin CC, Pantanelli SM, Kim SJ, Schallhorn JM. Management of Pain after Photorefractive Keratectomy: A Report by the American Academy of Ophthalmology. Ophthalmology. 2023 Jan;130(1):87-98. doi: 10.1016/j.ophtha.2022.07.028. Epub 2022 Oct 4.
PubMed 36207168Abdel-Radi M, Eldaly Z, Alattar S, Goda I. Preservative-Free Topical Anesthetic Unit-Dose Eye Drops for the Management of Postoperative Pain Following Photorefractive Keratectomy. Ophthalmol Ther. 2023 Dec;12(6):3025-3038. doi: 10.1007/s40123-023-00791-0. Epub 2023 Sep 4.
PubMed 37665497
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preservative-free Topical Anesthetics for the Management of Postoperative Pain Following Photorefractive Keratectomy
- ClinicalTrials.gov ID
- NCT05733741
- Acronym / sponsor ID
- PFTAPRK
- Conditions
- Myopia
- Keywords
- Post-PRK pain, Preservative-free topical anesthetics, Single-step PRK
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 30 Jan 2023 (actual)
- Primary completion
- 15 Apr 2023 (actual)
- Study completion
- 15 Apr 2023 (actual)
- First posted
- 17 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this interventional comparative study is to assess the efficacy and safety of a novel regimen of preservative-free unit-dose topical anesthetics for controlling early postoperative pain following single-step transepithelial PRK surgery.
The main research questions to answer are:
- Question 1: Are topical anesthetics effective in reducing post-PRK pain?
- Question 2: Are short-term topical anesthetics toxic to the cornea?
- Question 3: How to prevent abuse of topical anesthetics by patients at home?
Participants were planned to undergo a bilateral single-step transepithelial PRK surgery to correct their refractive errors and received a standard post-PRK treatment regimen for both eyes. Additionally, one eye was offered a preservative-free topical anesthetic as an experimental group and the other eye was offered a preservative-free artificial tear as a control group.
Detailed description
Photorefractive keratectomy (PRK) is a well-established surface ablation procedure for correction of refractive errors which involves the removal of corneal epithelium in a large diameter usually more than 6 mm followed by stromal ablation.
Early postoperative pain within the first few days after surgery is one of the commonest complications reported after PRK. The classic postoperative treatment includes the prescription of topical antibiotics and frequent preservative-free lubricants to accelerate epithelial healing.
The current treatment regimens also includes topical steroids, topical non-steroidal anti-inflammatory drugs (NSAID) and oral NSAID to reduce inflammation and post-PRK pain.
Earlier studies suggested that topical anesthetics in diluted concentrations and fractional doses didn't delay corneal epithelial regeneration after PRK but their use didn't gain popularity because of problems with topical formulation, stability and preservation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preservative-free topical anesthetics group | Experimental | Drug: Preservative-free Benoxinate hydrochloride 0.4% (Benoxidia unit-dose vials [UD], Orchidia pharmaceutical Ind., Egypt)Patients in this group had the standard post-PRK treatment regimen in addition to the prescription of preservative-free topical anesthetics for pain control following single-step transepithelial PRK surgery in one eye. |
| Preservative-free artificial tears group | Placebo comparator | Drug: Preservative-free Sodium hyaluronate 0.2% (Polyfresh unit-dose vials [UD], Orchidia pharmaceutical Ind., Egypt).Patients in this group had the standard post-PRK treatment regimen in addition to the prescription of preservative-free artificial tears as a placebo following single-step transepithelial PRK surgery in the other eye. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who are candidate for PRK surgery with
- Myopia up to - 6 diopters or myopic astigmatism up to - 4 diopters.
- Corneal thinnest pachymetry of 500 µm
- Residual stromal bed more than 350 µm after epithelial ablation.
Key exclusion criteria (6 listed)
- Patients with
- Corneal scars or dry eye disease,
- Past ocular surgery,
- History of contact lens wear,
- Systemic diseases such as diabetes mellitus and autoimmune diseases,
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 |
|---|---|---|
| Preservative-free Benoxinate hydrochloride 0.4% (Benoxidia unit-dose vials [UD], Orchidia pharmaceutical Ind., Egypt)For each patient, one eye was treated with preservative-free Benoxinate hydrochloride 0.4%. The prescribed regimen comprises of the instillation of one drop immediately, 2, 4, 6 and 8 hours after the end of surgery. Every patient was given 5 UD vials only of preservative-free Benoxinate hydrochloride 0.4% at each follow up visit for the next postoperative day usage administered 5 times daily (every 3 hours while awake) for the first 3 postoperative days giving clear instructions to immediately discard the vial after single use. | Drug | Preservative-free topical anesthetics group |
| Preservative-free Sodium hyaluronate 0.2% (Polyfresh unit-dose vials [UD], Orchidia pharmaceutical Ind., Egypt).The other eye was treated with preservative-free Sodium hyaluronate 0.2%. The prescribed regimen comprises of the instillation of one drop immediately, 2, 4, 6 and 8 hours after the end of surgery. Every patient was given 5 UD vials only of preservative-free Sodium hyaluronate 0.2% at each follow up visit for the next postoperative day usage administered 5 times daily (every 3 hours while awake) for the first 3 postoperative days giving clear instructions to immediately discard the vial after single use. | Drug | Preservative-free artificial tears group |
Primary outcome
Postoperative pain score on the verbal rating scale (VRS)
Time frame: 1 week
The doctor asks the patient to choose the word that best describes his/her pain and then gives it a score from zero to 4 (Zero for no pain, 1 for mild pain, 2 for moderate pain, 3 for severe pain and 4 for unbearable pain).
Postoperative pain score on the visual analogue scale (VAS)
Time frame: 1 week
The patient is asked to rate his/her pain by choosing a number on a scale from zero to 10 considering zero as no pain and 10 as worst possible pain.
2 secondary outcomes
Corneal epithelial healing duration
Time frame: 1 week
Endothelial cell density (ECD)
Time frame: from preoperative to 1 month postoperative.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2023.
- Background: PubMed 36207168Steigleman WA, Rose-Nussbaumer J, Al-Mohtaseb Z, Santhiago MR, Lin CC, Pantanelli SM, Kim SJ, Schallhorn JM. Management of Pain after Photorefractive Keratectomy: A Report by the American Academy of Ophthalmology. Ophthalmology. 2023 Jan;130(1):87-98. doi: 10.1016/j.ophtha.2022.07.028. Epub 2022 Oct 4.
- Derived from this study: PubMed 37665497Abdel-Radi M, Eldaly Z, Alattar S, Goda I. Preservative-Free Topical Anesthetic Unit-Dose Eye Drops for the Management of Postoperative Pain Following Photorefractive Keratectomy. Ophthalmol Ther. 2023 Dec;12(6):3025-3038. doi: 10.1007/s40123-023-00791-0. Epub 2023 Sep 4.
- 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.
Mahmoud Abdel-Radi, MD principal investigator
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Preservative-free Benoxinate hydrochloride 0.4% (Benoxidia unit-dose vials [UD], Orchidia pharmaceutical Ind., Egypt) and Preservative-free Sodium hyaluronate 0.2% (Polyfresh unit-dose vials [UD], Orchidia pharmaceutical Ind., Egypt). in people with Myopia, run by Assiut University at 1 site in Egypt.
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 4 inclusion and 6 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 24 May 2023. 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 Egypt. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Postoperative pain score on the verbal rating scale (VRS) (time frame: 1 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05733741, which also lists 2 linked publications.
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 24 May 2023.