PainPhase 3NCT01027611
Patient Assessment of Topical Anesthetic Effectiveness for Intravitreal Injections
A Phase 3 study testing proparacaine HCL 0.5%, proparacaine HCL 0.5% + 4% lidocaine solution and 3.5% viscous lidocaine gel in people with Pain, run by Illinois Retina Associates at 1 site in United States.
Trial summary
There are currently several different commercially available topical eye drops and gels used to reduce eye discomfort (topical anesthetics) during and after eye injections. Dr. Pollack is performing a research study to evaluate three commercially available topical anesthetics (eye numbing treatments) to determine if… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- What is being tested?
- proparacaine HCL 0.5%, proparacaine HCL 0.5% + 4% lidocaine solution and 3.5% viscous lidocaine gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Dec 2009
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients requiring intravitreal injection for treatment of eye disease
Who cannot join
- Eye infection
- Retinal detachment
- Age less than 18 years
- Pregnant
- Unable or unwilling to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
There are currently several different commercially available topical eye drops and gels used to reduce eye discomfort (topical anesthetics) during and after eye injections. Dr. Pollack is performing a research study to evaluate three commercially available topical anesthetics (eye numbing treatments) to determine if individuals have a preference for one over the other. The three topical anesthetics being studied are 1) 0.5% proparacaine hydrochloride (generic, Akorn, Inc), 2) 0.5% proparacaine hydrochloride (generic, Akorn, Inc) PLUS 4% lidocaine hydrochloride topical solution (generic, Roxane Laboratories), and 3) 3.5% lidocaine hydrochloride ophthalmic gel (Akten, Akorn, Inc). These eye anesthetics are NOT experimental medications. They are all commercially available topical anesthetics currently used in our offices and their use is widespread among retina specialists throughout the United States. Dr. Pollack will randomly select one topical anesthetic to use and he will ask you to grade your level of pain associated with the injection procedure. Answering these questions should take less than one minute of your time and your identity will NOT be revealed with the results of this study. The results of this study will be used to inform doctors which eye anesthetics patients find most effective for pain control during eye injections.
Read the detailed description
In this prospective study, 120 sequential patients undergoing 30 and 33 Gauge intravitreal injections were randomly assigned to receive either: proparacaine HCL 0.5% (Group 1), proparacaine HCL 0.5% + 4% lidocaine liquid drops (Group 2); or 3.5% lidocaine gel (Group 3) as topical anesthetic prior to injection. All procedures utilized a lid speculum and 5% povidone iodine. Approximately 10 seconds after injection, patients graded pain associated with the lid speculum, the needle, and with burning sensation on a pain scale of 0 to 10, with 0 representing no pain and 10 representing the patient's worst imaginable pain. They also graded their overall injection procedure experience as Excellent, Very Good, Fair, Poor, or Awful.
- Conditions
- Pain
- Being tested
- proparacaine HCL 0.5%, proparacaine HCL 0.5% + 4% lidocaine solution, 3.5% viscous lidocaine gel
- Keywords
- Effectiveness of topical pain medicine for control of pain associated with intravitreal injections, Eye discomfort
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
proparacaine HCL 0.5%Drug
proparacaine HCL 0.5% + 4% lidocaine solutionDrug
3.5% viscous lidocaine gelDrug
| Study group | Role | What they receive |
|---|---|---|
| proparacaine HCL 0.5% | Experimental | Not described Receives: Drug: proparacaine HCL 0.5% |
| proparacaine + lidocaine | Experimental | Not described Receives: Drug: proparacaine HCL 0.5% + 4% lidocaine solution |
| lidocaine gel | Experimental | Not described Receives: Drug: 3.5% viscous lidocaine gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Injection experience "grade"
Measured: Outcome data is obtained approximately 10 seconds after conclusion of procedure
Secondary outcomes (1)
Pain grades for lid speculum, needle insertion, povidone iodine burning/stinging
Measured: Outcome data is obtained approximately 10 seconds after conclusion of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2009 (estimated)
- Study startOct 2009
- Primary completionNov 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Illinois Retina Associates
- Sponsor type
- University, hospital or other
- Investigators
- John S. Pollack, MD, Study chair, Illinois Retina Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01027611
- Sponsor's protocol ID
- jsp-001
- Status last verified
- Dec 2009
- First submitted
- 4 Dec 2009
- Last updated
- 4 May 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Assessment of Topical Anesthetic Effectiveness for Intravitreal Injections
- ClinicalTrials.gov ID
- NCT01027611
- Acronym / sponsor ID
- jsp-001
- Conditions
- Pain
- Keywords
- Effectiveness of topical pain medicine for control of pain associated with intravitreal injections, Eye discomfort
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Illinois Retina AssociatesUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 8 Dec 2009 (estimated)
- 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.
There are currently several different commercially available topical eye drops and gels used to reduce eye discomfort (topical anesthetics) during and after eye injections. Dr. Pollack is performing a research study to evaluate three commercially available topical anesthetics (eye numbing treatments) to determine if individuals have a preference for one over the other. The three topical anesthetics being studied are 1) 0.5% proparacaine hydrochloride (generic, Akorn, Inc), 2) 0.5% proparacaine hydrochloride (generic, Akorn, Inc) PLUS 4% lidocaine hydrochloride topical solution (generic, Roxane Laboratories), and 3) 3.5% lidocaine hydrochloride ophthalmic gel (Akten, Akorn, Inc). These eye anesthetics are NOT experimental medications. They are all commercially available topical anesthetics currently used in our offices and their use is widespread among retina specialists throughout the United States. Dr. Pollack will randomly select one topical anesthetic to use and he will ask you to grade your level of pain associated with the injection procedure. Answering these questions should take less than one minute of your time and your identity will NOT be revealed with the results of this study. The results of this study will be used to inform doctors which eye anesthetics patients find most effective for pain control during eye injections.
Detailed description
In this prospective study, 120 sequential patients undergoing 30 and 33 Gauge intravitreal injections were randomly assigned to receive either: proparacaine HCL 0.5% (Group 1), proparacaine HCL 0.5% + 4% lidocaine liquid drops (Group 2); or 3.5% lidocaine gel (Group 3) as topical anesthetic prior to injection. All procedures utilized a lid speculum and 5% povidone iodine. Approximately 10 seconds after injection, patients graded pain associated with the lid speculum, the needle, and with burning sensation on a pain scale of 0 to 10, with 0 representing no pain and 10 representing the patient's worst imaginable pain. They also graded their overall injection procedure experience as Excellent, Very Good, Fair, Poor, or Awful.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| proparacaine HCL 0.5% | Experimental | Drug: proparacaine HCL 0.5% |
| proparacaine + lidocaine | Experimental | Drug: proparacaine HCL 0.5% + 4% lidocaine solution |
| lidocaine gel | Experimental | Drug: 3.5% viscous lidocaine gel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients requiring intravitreal injection for treatment of eye disease
Key exclusion criteria (5 listed)
- Eye infection
- Retinal detachment
- Age less than 18 years
- Pregnant
- Unable or unwilling to provide informed consent
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 |
|---|---|---|
| proparacaine HCL 0.5% | Drug | proparacaine HCL 0.5% |
| proparacaine HCL 0.5% + 4% lidocaine solution | Drug | proparacaine + lidocaine |
| 3.5% viscous lidocaine gel | Drug | lidocaine gel |
Primary outcome
Injection experience "grade"
Time frame: Outcome data is obtained approximately 10 seconds after conclusion of procedure
1 secondary outcome
Pain grades for lid speculum, needle insertion, povidone iodine burning/stinging
Time frame: Outcome data is obtained approximately 10 seconds after conclusion of procedure
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 4 May 2010.
Related trials for Pain
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
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.
John S. Pollack, MD study chair
Illinois Retina Associates
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 proparacaine HCL 0.5%, proparacaine HCL 0.5% + 4% lidocaine solution and 3.5% viscous lidocaine gel in people with Pain, run by Illinois Retina Associates 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 1 inclusion and 5 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 4 May 2010. 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. 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?
Injection experience "grade" (time frame: Outcome data is obtained approximately 10 seconds after conclusion of procedure). 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 4 May 2010; AzTrials last refreshed its copy on 8 Nov 2026.