Retinopathy of PrematurityPhase 3NCT06461975
Effect of Benoxinate Hydrochloride Eye Drops on The Premature Infant Pain Profile Score During Retinopathy of Prematurity Screening
A Phase 3 study testing Benoxinate Hydrochloride and artificial tear (Sodium Hyaluronate 2 mg/ml) eye drops. in people with Retinopathy of Prematurity, run by Alexandria University at 1 site in Egypt.
Trial summary
Aims: To evaluate the effects of topical Benoxinate HCL eye drops on the Premature Infant Pain Profile (PIPP) scores in infants undergoing Retinopathy of Prematurity (ROP) screening. Methods: A randomized prospective double-masked cross-over trial was conducted on preterm infants screened for ROP at least twice. Read more about this study
- Who is it for?
- Ages 28 to 90 days
- Conditions the study is for
- Retinopathy of Prematurity
- What is being tested?
- Benoxinate Hydrochloride and artificial tear (Sodium Hyaluronate 2 mg/ml) eye drops.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2023to 1 Jun 2023
- Phase
- Phase 3
- 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 28 to 90 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Preterm infants with GA ≤34 weeks and/or with birth weight ≤2000 g
- Preterm infants with larger GA or birth weight who were at increased risk of ROP according to the attending neonatologist
- Infants were believed to require at least 2 ROP screenings
Who cannot join
- Infants on muscle relaxants, analgesics, sedatives, or exogenous steroids
- Infants who required mechanical ventilation or continuous positive airway pressure at the first examination
Trial locations and contacts
1 site in 1 country.
About this study
Aims: To evaluate the effects of topical Benoxinate HCL eye drops on the Premature Infant Pain Profile (PIPP) scores in infants undergoing Retinopathy of Prematurity (ROP) screening.
Methods: A randomized prospective double-masked cross-over trial was conducted on preterm infants screened for ROP at least twice. Dilated fundus examination was done in Group A infants using the tear substitute eye drops and the second using the Benoxinate HCL drops and the reversed order of drops for Group B. Video recording of the pulse oximeter monitor, the face and the body of the infant were analyzed by a single neonatology consultant for Premature Infant Pain Profile (PIPP) scoring 1 minute before, during the examination of the first eye, 1 minute and 5 minutes after the conclusion of the examination of the second eye. The sound of the ophthalmologist on the video recordings indicating the time of the lid speculum insertion, the shining of the indirect ophthalmoscope light without indentation and the scleral indentation would aid in assessing the differences of the PIPP indicators during each step of the examination.
Read the detailed description
Aims: To evaluate the effects of topical Benoxinate HCL eye drops on Premature Infant Pain Profile (PIPP) scores in infants undergoing Retinopathy of Prematurity (ROP) screening.
Methods: A randomized prospective double-masked cross-over trial was conducted on preterm infants screened for ROP at least twice. Dilated fundus examination was done in Group A infants using the tear substitute eye drops and the second using the Benoxinate HCL drops and the reversed order of drops for Group B. Video recording of the pulse oximeter monitor, the face and the body of the infant were analyzed by a single neonatology consultant for Premature Infant Pain Profile (PIPP) scoring 1 minute before, during the examination of the first eye, 1 minute and 5 minutes after the conclusion of the examination of the second eye. The sound of the ophthalmologist on the video recordings indicating the time of the lid speculum insertion, the shining of the indirect ophthalmoscope light without indentation and the scleral indentation would aid in assessing the differences of the PIPP indicators during each step of the examination.
- Conditions
- Retinopathy of Prematurity
- Being tested
- Benoxinate Hydrochloride, artificial tear (Sodium Hyaluronate 2 mg/ml) eye drops.
- Keywords
- Infant stress, Retinopathy of prematurity, Benoxinate hydrochloride, PIPP score
- Medical subject headings
- Retinopathy of Prematurity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Benoxinate HydrochlorideDrug
Also called "Benox ®"
The first group had the first examination done using the tear substitute "Polyfresh ®" eye drops and the second using the Benoxinate HCL drops "Benox ®" given just before the ROP screening.
artificial tear (Sodium Hyaluronate 2 mg/ml) eye drops.Drug
Also called "Polyfresh ®"
The second group had the first examination done using the Benoxinate HCL drops "Benox ®" eye drops and the second using the tear substitute "Polyfresh ®"given just before the ROP screening.
| Study group | Role | What they receive |
|---|---|---|
| Tear substitute in first exam | Experimental | Te first examination was done using the tear substitute eye drops and the second using the Benoxinate HCL drops given just before the ROP screening. Receives: Drug: artificial tear (Sodium Hyaluronate 2 mg/ml) eye drops. |
| Benoxinate HCL in first exam | Experimental | infants in Group B had the reversed order of the drops in the two examinations. the first examination done using the Benoxinate HCL drops and the second using the tear substitute eye drops Receives: Drug: Benoxinate Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
PIPP score
The PIPP is a composite measure that includes seven indicators, each of which is rated on a four-point scale (0-3). The indicators include heart rate, oxygen saturation, GA, brow bulge, nasolabial furrow, behavioural state, and eye squeeze. Larger number indicates more stress (worse outcome)
Measured: 1-3 month after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2024
- Study start1 Jan 2023
- Primary completion30 Apr 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinopathy of PrematurityStudies of the same condition, open and under way.
- More trials run by Alexandria 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 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Prospective, observational, double-blinded, cross-over
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Islam Shereen Hamdy, Alexandria University
- Investigators
- Islam Ahmed, M.D., Principal investigator, University of Alexandria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06461975
- Sponsor's protocol ID
- Benoxinate drops for ROP exam
- Status last verified
- Jun 2024
- First submitted
- 6 Jun 2024
- Last updated
- 17 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data are available and owned by the authors and can be shared upon request
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Benoxinate Hydrochloride Eye Drops on The Premature Infant Pain Profile Score During Retinopathy of Prematurity Screening
- ClinicalTrials.gov ID
- NCT06461975
- Acronym / sponsor ID
- Benoxinate drops for ROP exam
- Conditions
- Retinopathy of Prematurity
- Keywords
- Infant stress, Retinopathy of prematurity, Benoxinate hydrochloride, PIPP score
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 17 Jun 2024 (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.
Aims: To evaluate the effects of topical Benoxinate HCL eye drops on the Premature Infant Pain Profile (PIPP) scores in infants undergoing Retinopathy of Prematurity (ROP) screening.
Methods: A randomized prospective double-masked cross-over trial was conducted on preterm infants screened for ROP at least twice. Dilated fundus examination was done in Group A infants using the tear substitute eye drops and the second using the Benoxinate HCL drops and the reversed order of drops for Group B. Video recording of the pulse oximeter monitor, the face and the body of the infant were analyzed by a single neonatology consultant for Premature Infant Pain Profile (PIPP) scoring 1 minute before, during the examination of the first eye, 1 minute and 5 minutes after the conclusion of the examination of the second eye. The sound of the ophthalmologist on the video recordings indicating the time of the lid speculum insertion, the shining of the indirect ophthalmoscope light without indentation and the scleral indentation would aid in assessing the differences of the PIPP indicators during each step of the examination.
Detailed description
Aims: To evaluate the effects of topical Benoxinate HCL eye drops on Premature Infant Pain Profile (PIPP) scores in infants undergoing Retinopathy of Prematurity (ROP) screening.
Methods: A randomized prospective double-masked cross-over trial was conducted on preterm infants screened for ROP at least twice. Dilated fundus examination was done in Group A infants using the tear substitute eye drops and the second using the Benoxinate HCL drops and the reversed order of drops for Group B. Video recording of the pulse oximeter monitor, the face and the body of the infant were analyzed by a single neonatology consultant for Premature Infant Pain Profile (PIPP) scoring 1 minute before, during the examination of the first eye, 1 minute and 5 minutes after the conclusion of the examination of the second eye. The sound of the ophthalmologist on the video recordings indicating the time of the lid speculum insertion, the shining of the indirect ophthalmoscope light without indentation and the scleral indentation would aid in assessing the differences of the PIPP indicators during each step of the examination.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, observational, double-blinded, cross-over
| Arm | Type | Receives |
|---|---|---|
| Tear substitute in first exam | Experimental | Drug: artificial tear (Sodium Hyaluronate 2 mg/ml) eye drops.Te first examination was done using the tear substitute eye drops and the second using the Benoxinate HCL drops given just before the ROP screening. |
| Benoxinate HCL in first exam | Experimental | Drug: Benoxinate Hydrochlorideinfants in Group B had the reversed order of the drops in the two examinations. the first examination done using the Benoxinate HCL drops and the second using the tear substitute eye drops |
Who may qualify
- Ages
- 28 to 90 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Preterm infants with GA ≤34 weeks and/or with birth weight ≤2000 g
- Preterm infants with larger GA or birth weight who were at increased risk of ROP according to the attending neonatologist
- Infants were believed to require at least 2 ROP screenings
Key exclusion criteria (2 listed)
- Infants on muscle relaxants, analgesics, sedatives, or exogenous steroids
- Infants who required mechanical ventilation or continuous positive airway pressure at the first examination
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 |
|---|---|---|
| Benoxinate HydrochlorideAlso: "Benox ®"The first group had the first examination done using the tear substitute "Polyfresh ®" eye drops and the second using the Benoxinate HCL drops "Benox ®" given just before the ROP screening. | Drug | Benoxinate HCL in first exam |
| artificial tear (Sodium Hyaluronate 2 mg/ml) eye drops.Also: "Polyfresh ®"The second group had the first examination done using the Benoxinate HCL drops "Benox ®" eye drops and the second using the tear substitute "Polyfresh ®"given just before the ROP screening. | Drug | Tear substitute in first exam |
Primary outcome
PIPP score
Time frame: 1-3 month after birth
The PIPP is a composite measure that includes seven indicators, each of which is rated on a four-point scale (0-3). The indicators include heart rate, oxygen saturation, GA, brow bulge, nasolabial furrow, behavioural state, and eye squeeze. Larger number indicates more stress (worse outcome)
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 17 Jun 2024.
- Individual participant dataSharing planned: No. Data are available and owned by the authors and can be shared upon request
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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.
Islam Ahmed, M.D. principal investigator
University of Alexandria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Benoxinate Hydrochloride and artificial tear (Sodium Hyaluronate 2 mg/ml) eye drops. in people with Retinopathy of Prematurity, run by Alexandria 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 3 inclusion and 2 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 17 Jun 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 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
PIPP score (time frame: 1-3 month after birth). 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 17 Jun 2024.