Pain ReductionPhase 4NCT04829799
Effect of Intracameral Phenylephrine/Ketorolac on Intraoperative Pain
A Phase 4 study testing 1% preservative-free lidocaine and Phenylephrine 1.0%/ Ketorolac 0.3% in people with Pain Reduction, run by University of Florida.
Trial summary
To compare the effect of intraoperative intracameral Omidria (Phenylephrine and Ketorolac 1.0%/0.3%) verses 1% Lidocaine on pain reduction during and after cataract surgery. Read more about this study
- Who is it for?
- Ages 40 to 95 years
- Conditions the study is for
- Pain Reduction
- What is being tested?
- 1% preservative-free lidocaine and Phenylephrine 1.0%/ Ketorolac 0.3%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Feb 2022to Aug 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 40 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals with a cataract in the surgical eye
Who cannot join
- Patients that have previously exhibited sensitivities to acetylsalicylic acid, phenylacetic acid derivative, and other nonsteroidal anti-inflammatory drugs (NSAIDs)
- Those with a past medical history of asthma
- Those systemically using opioids or nonsteroidal anti-inflammatory drugs
- Those prescribed additional topical mydriatics, topical steroids, pilocarpine, or prostaglandins in the week preceding surgery
- Those with a history of alpha-1-adrenergic antagonist use
- Those with excisional, intraocular surgery in the planned surgical eye in the preceding year
Show all 9Show fewer
- Those with a history of iris damage
- Those requiring iris expanding device or those with an acute or chronic uncontrolled eye condition, or those unable to effectively remember surgery or complete the post-operative assessment.
- Additionally, individuals less than 21 will be excluded.
About this study
To compare the effect of intraoperative intracameral Omidria (Phenylephrine and Ketorolac 1.0%/0.3%) verses 1% Lidocaine on pain reduction during and after cataract surgery.
- Conditions
- Pain Reduction
- Being tested
- 1% preservative-free lidocaine, Phenylephrine 1.0%/ Ketorolac 0.3%
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1% preservative-free lidocaineDrug
Instillation of intracameral lidocaine after initial paracentesis incision.
Phenylephrine 1.0%/ Ketorolac 0.3%Drug
Instillation of Omidria irrigation solution after paracentesis incision and in irrigation solution.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Subjects will receive intracameral 1% preservative-free lidocaine following paracentesis Receives: Drug: 1% preservative-free lidocaine |
| Study Experimental Group | Experimental | Subject will receive Omidria (phenylephrine and ketorolac (1.0%/0.3%) added to the ophthalmic irrigating solution during the cataract extraction procedure Receives: Drug: Phenylephrine 1.0%/ Ketorolac 0.3% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analog scale to measure pain
Measurement of pain intensity by mean visual analog scale (VAS) pain scores from 0 (no pain) to 10 (extreme pain) during operation
Measured: Day 1 of operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2021
- Study startFeb 2022 (estimated)
- Primary completionAug 2023 (estimated)
- Study completionAug 2023 (estimated)
Why it stopped: Per study team, the study will not proceed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain ReductionStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Omeros Corporation
- Responsible party
- Sponsor
- Investigators
- Eric Grieser, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04829799
- Sponsor's protocol ID
- IRB202002831 -A
- Other IDs
- OCR40493
- Status last verified
- Jun 2022
- First submitted
- 31 Mar 2021
- Last updated
- 13 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 13 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intracameral Phenylephrine/Ketorolac on Intraoperative Pain
- ClinicalTrials.gov ID
- NCT04829799
- Acronym / sponsor ID
- IRB202002831 -A
- Conditions
- Pain Reduction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Per study team, the study will not proceed
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- Omeros Corporation
- Study start
- Feb 2022 (estimated)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Aug 2023 (estimated)
- First posted
- 2 Apr 2021 (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.
To compare the effect of intraoperative intracameral Omidria (Phenylephrine and Ketorolac 1.0%/0.3%) verses 1% Lidocaine on pain reduction during and after cataract surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Drug: 1% preservative-free lidocaineSubjects will receive intracameral 1% preservative-free lidocaine following paracentesis |
| Study Experimental Group | Experimental | Drug: Phenylephrine 1.0%/ Ketorolac 0.3%Subject will receive Omidria (phenylephrine and ketorolac (1.0%/0.3%) added to the ophthalmic irrigating solution during the cataract extraction procedure |
Who may qualify
- Ages
- 40 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Individuals with a cataract in the surgical eye
Key exclusion criteria (9 listed)
- Patients that have previously exhibited sensitivities to acetylsalicylic acid, phenylacetic acid derivative, and other nonsteroidal anti-inflammatory drugs (NSAIDs)
- Those with a past medical history of asthma
- Those systemically using opioids or nonsteroidal anti-inflammatory drugs
- Those prescribed additional topical mydriatics, topical steroids, pilocarpine, or prostaglandins in the week preceding surgery
- Those with a history of alpha-1-adrenergic antagonist use
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 |
|---|---|---|
| 1% preservative-free lidocaineInstillation of intracameral lidocaine after initial paracentesis incision. | Drug | Control Group |
| Phenylephrine 1.0%/ Ketorolac 0.3%Instillation of Omidria irrigation solution after paracentesis incision and in irrigation solution. | Drug | Study Experimental Group |
Primary outcome
Visual analog scale to measure pain
Time frame: Day 1 of operation
Measurement of pain intensity by mean visual analog scale (VAS) pain scores from 0 (no pain) to 10 (extreme pain) during operation
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2022.
- 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.
Eric Grieser, MD principal investigator
University of Florida
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 1% preservative-free lidocaine and Phenylephrine 1.0%/ Ketorolac 0.3% in people with Pain Reduction, run by University of Florida.
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 9 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: withdrawn, as of the sponsor's last update on 13 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
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 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 was withdrawn before enrolling participants, so there are no results.
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?
Visual analog scale to measure pain (time frame: Day 1 of operation). 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 13 Jun 2022.