PainPhase 4NCT00869219
Comparison of Pain Sensation During Single Use of Two Topical Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
A Phase 4 study testing Nevanac and Acular LS in people with Pain, run by Santa Casa de Misericordia de Santos at 1 site in Brazil.
Trial summary
Different case reports are showing that depending on the drug used for eye drops, it might provoke a painful sensation. Actually two leading NSAIDs are used in ophthalmology. This study is intended to provide information about this parameter concerning these two drugs. Read more about this study
- Who is it for?
- Ages 21 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Nevanac and Acular LS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2009to Aug 2009
- 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 21 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient over 21 years old
- No ocular surface pathology
- Eligible for cataract surgery
Who cannot join
- Any other eye pathology other than cataract
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Santa Casa de Misericordia de Santos
Santos, São Paulo, 11055360
Gustavo T Grottone, MD, MBA, MSc, 551381515130, gtg2001@terra.com.br
Gustavo T Grottone, MD, MBA
About this study
Official title: Phase 4 Study of Topical NSAID for Ophthalmologic Use: Pain Measurement After First Drop.
Different case reports are showing that depending on the drug used for eye drops, it might provoke a painful sensation. Actually two leading NSAIDs are used in ophthalmology. This study is intended to provide information about this parameter concerning these two drugs.
- Conditions
- Pain
- Being tested
- Nevanac, Acular LS
- Keywords
- Pain, Pain after eyedrops
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NevanacDrug
1 drop of NEVANAC at random eye
Acular LSDrug
One drop of Acular LS
| Study group | Role | What they receive |
|---|---|---|
| Nevanac | Active comparator | Not described Receives: Drug: Nevanac |
| Acular LS | Active comparator | Not described Receives: Drug: Acular LS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain after instilation
Measured: 5 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionAug 2009 (estimated)
- Study completionAug 2009 (estimated)
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Santa Casa de Misericordia de Santos
- Sponsor type
- University, hospital or other
- Investigators
- Gustavo T Grottone, MD, MBA,MSc, Principal investigator, SCMSJoão C Grottone, MD, MBA, Study chair, SCMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00869219
- Sponsor's protocol ID
- SCMisericordiaSantos
- Status last verified
- Mar 2009
- First submitted
- 23 Mar 2009
- Last updated
- 26 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4 Study of Topical NSAID for Ophthalmologic Use: Pain Measurement After First Drop.
- ClinicalTrials.gov ID
- NCT00869219
- Acronym / sponsor ID
- SCMisericordiaSantos
- Conditions
- Pain
- Keywords
- Pain, Pain after eyedrops
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Santa Casa de Misericordia de SantosUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Aug 2009 (estimated)
- Study completion
- Aug 2009 (estimated)
- First posted
- 25 Mar 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.
Different case reports are showing that depending on the drug used for eye drops, it might provoke a painful sensation. Actually two leading NSAIDs are used in ophthalmology. This study is intended to provide information about this parameter concerning these two drugs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nevanac | Active comparator | Drug: Nevanac |
| Acular LS | Active comparator | Drug: Acular LS |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient over 21 years old
- No ocular surface pathology
- Eligible for cataract surgery
Key exclusion criteria (1 listed)
- Any other eye pathology other than cataract
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 |
|---|---|---|
| Nevanac1 drop of NEVANAC at random eye | Drug | Nevanac |
| Acular LSOne drop of Acular LS | Drug | Acular LS |
Primary outcome
Pain after instilation
Time frame: 5 min
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2009.
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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.
Gustavo T Grottone, MD, MBA,MSc principal investigator
SCMS
João C Grottone, MD, MBA study chair
SCMS
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 Nevanac and Acular LS in people with Pain, run by Santa Casa de Misericordia de Santos at 1 site in Brazil.
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 1 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: status not confirmed, as of the sponsor's last update on 26 Mar 2009. 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 Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gustavo T Grottone, MD, MBA, MSc (551381515130, gtg2001@terra.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain after instilation (time frame: 5 min). 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 26 Mar 2009.