PainPhase 4NCT01383200
Tetracaine Versus Lidocaine Gel for Anesthetic Effect and Comfort in Patients Undergoing LASIK
A Phase 4 study testing Tetracaine drop and Lidocaine gel in people with Pain, run by University of Miami at 1 site in United States.
Trial summary
In this study the investigators will be comparing two different types of anesthetic, a numbing eye drop and a numbing gel, to test if they are equally effective or if one has a better outcome in terms of the level of comfort you experience one hour and one day after your surgery. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Tetracaine drop and Lidocaine gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Oct 2011
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy volunteers of age 18 years or greater
Who cannot join
- Previous reaction/allergy to the same drug class
- prior ocular surgery
- active facial injuries
- any active current ophthalmological disease
- history of diabetes
- any current non- Over The Counter pain medication
Show all 10Show fewer
- inability to complete the questionnaire.
- Economically or educationally disadvantaged persons, Prisoners, or Children
- Patients with fluctuating or impaired decision-making capacity
- Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of 0.5% Tetracaine Drops Versus 2% Lidocaine Gel for Anesthetic Efficacy and Comfort in Patients Undergoing LASIK
In this study the investigators will be comparing two different types of anesthetic, a numbing eye drop and a numbing gel, to test if they are equally effective or if one has a better outcome in terms of the level of comfort you experience one hour and one day after your surgery. The two medications are commonly used and appear to be equally effective for other types of eye surgery, such as cataract surgery. This study will show if one type of anesthesia is preferred over another by patients getting LASIK. Before your LASIK procedure, you will be given a short questionnaire to determine the baseline comfort of your eyes. In the operating room, one type of anesthetic will be put in one eye, and the other medication will be put in the other eye. Which anesthetic you get in each eye will be chosen in a random way (similar to flipping a coin). After your LASIK surgery, the investigators will ask you if you felt more comfort in your right eye, your left eye, or if they were equal, and the investigators will ask you the same survey questions that were asked prior to your LASIK to get more details about your experience.
*Of note- the randomization being done is for which eye will be receiving the lidocaine and which eye will be receiving the tetracaine. Each patient will receive lidocaine in 1 eye and tetracaine in the other eye, the randomization is for each individual eye. This means, of 11 patients in our study, 22 eyes received treatment. 11 eyes received lidocaine and 11 eyes received tetracaine.
when we did our comparison, 11 values were used for lidocaine and 11 eyes were used for tetracaine, giving a total of 22 eyes. This is important to note since the randomization refers to EYE for each individual patient, and not for the patient (ie: participant means 1 eye, not 1 person in the descriptions below).
Read the detailed description
Outcome measures involve comparing the right eye and left eye for severity of 12 different symptoms, that are recorded in severity on a 1-5 scale. A score of 1 means no symptoms and 5 means severe. The 12 measurements include sharp pain, dull ache, pain during movement, stinging sensation, itching, light sensitivity, watery eyes, dry eyes, sandy sensation, pressure sensation, decreased vision, and blurry vision.
- Conditions
- Pain
- Being tested
- Tetracaine drop, Lidocaine gel
- Keywords
- efficacy, comfort
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tetracaine dropDrug
Also called TetraVisc, Altacaine, AK-T-Caine and Pontocaine Ophthalmic
0.5% Tetracaine Right eye / 2% Lidocaine Left eye
Lidocaine gelDrug
Also called Akten
0.5% Tetracaine Left eye / 2% Lidocaine Right eye
| Study group | Role | What they receive |
|---|---|---|
| Tetracaine R/Lidocaine L | Active comparator | Participant's Right or Left eye will receive 0.5% Tetracaine drop, at 10 minutes and 5 minutes, prior to LASIK. Receives: Drug: Tetracaine drop; Drug: Lidocaine gel |
| Tetracaine L/Lidocaine R | Active comparator | Participant's Right or Left eye will receive 2% lidocaine gel, at 10 minutes and 5 minutes, prior to LASIK. Receives: Drug: Tetracaine drop; Drug: Lidocaine gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants Score on Pain Scale
Do you have sharp pain in your eye? Pain will be assessed by units on a scale of 1-5: 1 means no symptoms, 2 means slight discomfort, 3 means mild discomfort, 4 means moderate discomfort, and 5 means severe discomfort
Measured: 1 hour (60minutes) post LASIK operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionOct 2011
- Study completionOct 2011
Why it stopped: eyes that received gel had slightly thinner than intended flaps
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by University of MiamiThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sonia Yoo, University of Miami
- Investigators
- SONIA YOO, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01383200
- Sponsor's protocol ID
- 20101016
- Status last verified
- Jun 2017
- First submitted
- 13 Jun 2011
- Last updated
- 11 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Shah NV, Vaddavalli PK, Chow JH, Roman JS, Shi W, Yoo SH. Prospective, double-masked, randomized trial comparing lidocaine gel to tetracaine drops in femtosecond laser-assisted LASIK. J Refract Surg. 2012 Oct;28(10):671-2. doi: 10.3928/1081597X-20121001-05. No abstract available.
PubMed 23061994
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of 0.5% Tetracaine Drops Versus 2% Lidocaine Gel for Anesthetic Efficacy and Comfort in Patients Undergoing LASIK
- ClinicalTrials.gov ID
- NCT01383200
- Acronym / sponsor ID
- 20101016
- Conditions
- Pain
- Keywords
- efficacy, comfort
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: eyes that received gel had slightly thinner than intended flaps
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 28 Jun 2011 (estimated)
- Results
- Posted 1 Apr 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study the investigators will be comparing two different types of anesthetic, a numbing eye drop and a numbing gel, to test if they are equally effective or if one has a better outcome in terms of the level of comfort you experience one hour and one day after your surgery. The two medications are commonly used and appear to be equally effective for other types of eye surgery, such as cataract surgery. This study will show if one type of anesthesia is preferred over another by patients getting LASIK. Before your LASIK procedure, you will be given a short questionnaire to determine the baseline comfort of your eyes. In the operating room, one type of anesthetic will be put in one eye, and the other medication will be put in the other eye. Which anesthetic you get in each eye will be chosen in a random way (similar to flipping a coin). After your LASIK surgery, the investigators will ask you if you felt more comfort in your right eye, your left eye, or if they were equal, and the investigators will ask you the same survey questions that were asked prior to your LASIK to get more details about your experience.
*Of note- the randomization being done is for which eye will be receiving the lidocaine and which eye will be receiving the tetracaine. Each patient will receive lidocaine in 1 eye and tetracaine in the other eye, the randomization is for each individual eye. This means, of 11 patients in our study, 22 eyes received treatment. 11 eyes received lidocaine and 11 eyes received tetracaine.
when we did our comparison, 11 values were used for lidocaine and 11 eyes were used for tetracaine, giving a total of 22 eyes. This is important to note since the randomization refers to EYE for each individual patient, and not for the patient (ie: participant means 1 eye, not 1 person in the descriptions below).
Detailed description
Outcome measures involve comparing the right eye and left eye for severity of 12 different symptoms, that are recorded in severity on a 1-5 scale. A score of 1 means no symptoms and 5 means severe. The 12 measurements include sharp pain, dull ache, pain during movement, stinging sensation, itching, light sensitivity, watery eyes, dry eyes, sandy sensation, pressure sensation, decreased vision, and blurry vision.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tetracaine R/Lidocaine L | Active comparator | Drug: Tetracaine drop, Drug: Lidocaine gelParticipant's Right or Left eye will receive 0.5% Tetracaine drop, at 10 minutes and 5 minutes, prior to LASIK. |
| Tetracaine L/Lidocaine R | Active comparator | Drug: Tetracaine drop, Drug: Lidocaine gelParticipant's Right or Left eye will receive 2% lidocaine gel, at 10 minutes and 5 minutes, prior to LASIK. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- healthy volunteers of age 18 years or greater
Key exclusion criteria (10 listed)
- Previous reaction/allergy to the same drug class
- prior ocular surgery
- active facial injuries
- any active current ophthalmological disease
- history of diabetes
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 |
|---|---|---|
| Tetracaine dropAlso: TetraVisc, Altacaine, AK-T-Caine and Pontocaine Ophthalmic0.5% Tetracaine Right eye / 2% Lidocaine Left eye | Drug | Tetracaine L/Lidocaine R, Tetracaine R/Lidocaine L |
| Lidocaine gelAlso: Akten0.5% Tetracaine Left eye / 2% Lidocaine Right eye | Drug | Tetracaine L/Lidocaine R, Tetracaine R/Lidocaine L |
Primary outcome
Participants Score on Pain Scale
Time frame: 1 hour (60minutes) post LASIK operation
Do you have sharp pain in your eye? Pain will be assessed by units on a scale of 1-5: 1 means no symptoms, 2 means slight discomfort, 3 means mild discomfort, 4 means moderate discomfort, and 5 means severe discomfort
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23061994Shah NV, Vaddavalli PK, Chow JH, Roman JS, Shi W, Yoo SH. Prospective, double-masked, randomized trial comparing lidocaine gel to tetracaine drops in femtosecond laser-assisted LASIK. J Refract Surg. 2012 Oct;28(10):671-2. doi: 10.3928/1081597X-20121001-05. No abstract available.
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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.
SONIA YOO, MD principal investigator
University of Miami
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 Tetracaine drop and Lidocaine gel in people with Pain, run by University of Miami 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 10 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: stopped early, as of the sponsor's last update on 11 Aug 2017. 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 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?
Yes. Results are posted in the registry (first posted 1 Apr 2015). 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?
Participants Score on Pain Scale (time frame: 1 hour (60minutes) post LASIK operation). 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 NCT01383200, which also lists 1 linked publication.
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 11 Aug 2017; AzTrials last refreshed its copy on 8 Nov 2026.