Post Surgical ManagementNCT02506348
Comparison of Diclofenac vs. Nepafenac Ophthalmic Drops: Patient Comfort
A study testing Diclofenac and Nepafenac in people with Post Surgical Management and Pain Management, run by Wolfson Medical Center at 1 site in Israel.
Trial summary
In this study we test Diclofenac and Nepafenac and compared patients experience and comfort following administration of these ophthalmic drops. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Surgical Management, Pain Management, Inflamation Management
- What is being tested?
- Diclofenac and Nepafenac
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2015to Jan 2016
- Phase
- Interventional
- 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
- patient facing cataract surgery
Who cannot join
- under 18
- cognitive decline
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
The E.Wolfson Medical Center
Holon, 58100
Asaf Achiron, MD, +97235028706
Keren Pelleg, +97235035713, kerenp@wolfson.health.gov.il
About this study
In this study we test Diclofenac and Nepafenac and compared patients experience and comfort following administration of these ophthalmic drops.
Read the detailed description
In this study we will compare the ocular tolerability between preservative-free Diclofenac and Nepafenac drops. Using a standard comparative scale we will measured discomfort, itching, burning and pain in intervals of 1 sec, 5 sec, 1 min and 5 min post-administration.
The results may aid both doctors and patients in decision regarding the post surgical anti-inflammatory treatment.
- Being tested
- Diclofenac, Nepafenac
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiclofenacDrug
NepafenacDrug
| Study group | Role | What they receive |
|---|---|---|
| Diclofenac+Nepafenac | Experimental | one drop Diclofenac in one eye one drop Nepafenac in other eye Receives: Drug: Diclofenac; Drug: Nepafenac |
What is being measured
The primary outcome is the main question the study is designed to answer.
patient's comfort
change in patient's comfort between both eyes at 1 min post administration
Measured: 1 min post administration
Secondary outcomes (1)
patient's comfort
change in patient's comfort between both eyes at 10 min post administration
Measured: 5 min post administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionJan 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Surgical ManagementStudies 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 N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wolfson Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Asaf Achiron, Wolfson Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02506348
- Sponsor's protocol ID
- 0011-15
- Status last verified
- Jul 2015
- First submitted
- 2 Jul 2015
- Last updated
- 24 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Diclofenac vs. Nepafenac Ophthalmic Drops: Patient Comfort
- ClinicalTrials.gov ID
- NCT02506348
- Acronym / sponsor ID
- 0011-15
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Wolfson Medical CenterOther government
- Study start
- Jul 2015
- Primary completion
- Jan 2016 (estimated)
- First posted
- 23 Jul 2015 (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.
In this study we test Diclofenac and Nepafenac and compared patients experience and comfort following administration of these ophthalmic drops.
Detailed description
In this study we will compare the ocular tolerability between preservative-free Diclofenac and Nepafenac drops. Using a standard comparative scale we will measured discomfort, itching, burning and pain in intervals of 1 sec, 5 sec, 1 min and 5 min post-administration.
The results may aid both doctors and patients in decision regarding the post surgical anti-inflammatory treatment.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diclofenac+Nepafenac | Experimental | Drug: Diclofenac, Drug: Nepafenacone drop Diclofenac in one eye one drop Nepafenac in other eye |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patient facing cataract surgery
Key exclusion criteria (2 listed)
- under 18
- cognitive decline
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 |
|---|---|---|
| Diclofenac | Drug | Diclofenac+Nepafenac |
| Nepafenac | Drug | Diclofenac+Nepafenac |
Primary outcome
patient's comfort
Time frame: 1 min post administration
change in patient's comfort between both eyes at 1 min post administration
1 secondary outcome
patient's comfort
Time frame: 5 min post administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2015.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diclofenac and Nepafenac in people with Post Surgical Management and Pain Management, run by Wolfson Medical Center at 1 site in Israel.
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 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: status not confirmed, as of the sponsor's last update on 24 Jul 2015. 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 Israel. 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.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
patient's comfort (time frame: 1 min post administration). 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 24 Jul 2015.