PainNCT02837770
Effect of Topical and Oral Diclofenac on Pain Related to Intravitreal Injections
A study testing Diclofenac Eye Drops, Pacebo pill and Oral Diclofenac in people with Pain, run by University Hospital of Patras at 1 site in Greece.
Trial summary
The analgestic efffect of Diclofenac Sodium 0.1% Eye Drops and a combination of Diclofenac Sodium 0.1% Eye Drops and oral Diclofenac Sodium sustained-release 75mg tablets on pain related to intravitreal injections will be evalutated. Pain perception will be assessed by the Short Form of the McGill Pain Questionnaire. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- What is being tested?
- Diclofenac Eye Drops, Pacebo pill and Oral Diclofenac
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteGreece
- Study dates
- Jul 2016to Jan 2017
- 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
- All participants will be patients of the Medical Retina Department of our Clinic, who are scheduled to receive IVIs of ranibizumab (Lucentis; Novartis Pharma S.A.S., Huningue, France) or aflibercept (Eylea; Bayer Healthcare Pharmaceuticals, Berlin, Germany) in one eye and had already undergone at least one IVI of an anti-VEGF agent.
Who cannot join
- History of previous eye surgery other than cataract extraction surgery, herpetic eye disease, uncontrolled glaucoma, uveitis, active conjunctivitis, keratitis and bullous keratopathy, a previously known allergic response to diclofenac or other NSAIDs and salicylates, any contraindication to NSAIDs administration such as cardiovascular disease, gastrointenstinal disease with risk of GI ulceration,bleeding and perforation, renal and hepatic disease and any systemic or topical use of NSAIDs or any use of sedative medications within 7 days from the visit and during the day of IVI.
- Patients with poor cooperation in understanding and answering the questions of the SF-MPQ, including the visual analogue scale (VAS).
- Unsuccessful blinding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analgesic Effect of Topical and Oral Diclofenac on Pain Related to Intravitreal Injections, a Randomized, Triple-arm, Double-blind, Placebo-controlled Study.
The analgestic efffect of Diclofenac Sodium 0.1% Eye Drops and a combination of Diclofenac Sodium 0.1% Eye Drops and oral Diclofenac Sodium sustained-release 75mg tablets on pain related to intravitreal injections will be evalutated.
Pain perception will be assessed by the Short Form of the McGill Pain Questionnaire.
Read the detailed description
Intravitreal injection (IVI) is a preferred route of administration of drugs in the posterior segment of the eye. Intravitreal injection of anti-VEGFs constitutes the mainstay for the treatment of various retinal diseases such as AMD, RVO, DME etc.
The procedure of the IVI is, however, associated with a level of discomfort for the patient.
Nonsteroidal anti-inflammatory drugs (NSAIDs) inhibit the activity of cyclooxygenase-1 and cyclooxygenase-2, and thereby, the synthesis of prostaglandins and thromboxanes. Cyclooxygenase-2 inhibition leads to the anti-inflammatory, analgesic and antipyretic effects of NSAIDs.
Ophthalmic NSAIDs constitute an established and effective treatment option for the management of inflammation and pain associated with cataract surgery and of pain associated with corneal refractive surgery, for inhibition of intraoperative miosis and for the treatment of seasonal allergic conjunctivitis.
The primary goal of this study is to assess the analgesic effect of DIclofenac 0.1% Eye Drops a topical NSAID, as well as a combination of Diclofenac 0.1% Eye Drops and oral Diclofenac Sodium sustained-release (SR) 75mg tablets on pain related to intravitreal injections immediately after and up to six hours post-IVI.
A number of patients scheduled to undergo IVIs of anti-VEGFs will be randomized and divided in three groups. All patients must have already undergone at least one IVI. In patients receiving IVIs in both eyes only one eye will be included in the study.
The patients of the first group will receive placebo pill 4 hours before the IVI and Diclofenac 0.1 % Eye Drops 45 minutes prior to the injection.
The patients of the second group will recieve oral Diclofenac Sodium SR 75mg/tb 4 hours prior to the injection and Diclofenac 0.1% Eye Drops 45 minutes prior to the injection.
The patients of the third group will receive placebo pill 4 hours and Artificial Tears 45 minutes prior to the injection.
Patients will be required to complete the greek version of the short form McGill Pain Questionnaire (SF-MPQ) comprising of the Visual Analogue Scale, the main component of the SF-MPQ and the Present Pain Intensity Scale immediately after the injection and 6 hours post-IVI.
- Conditions
- Pain
- Being tested
- Diclofenac Eye Drops, Pacebo pill, Oral Diclofenac, Artificial Tears
- Keywords
- pain, intravitreal injection, anti-VEGF, diclofenac eye drops, oral diclofenac, Short Form of McGill Pain Questionnaire
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diclofenac Eye DropsDrug
Also called DENACLOF EY.DRO.SOL 0.1% (W/V)
One drop of Diclofenac 0.1% will be instilled 45' prior to the IVI.
Pacebo pillDrug
Pacebo pill will be administered 4 hours before the IVI.
Oral DiclofenacDrug
Also called VOLTAREN S.R.F.C. 75MG/TAB
One Diclofenac Sodium sustained-release 75mg tablet administered per os 4 hours prior to the IVI.
Diclofenac Eye DropsDrug
Also called DENACLOF EY.DRO.SOL 0.1% (W/V)
One drop of Diclofenac 0.1% will be instilled 45' prior to the IVI.
Pacebo pillDrug
Pacebo pill will be administered 4 hours before the IVI.
Artificial TearsDrug
Also called TEARS NATURALE 0,1%+0,3% EY.DRO.SOL.
One drop Artificial Tears will be instilled 45' prior to the IVI.
| Study group | Role | What they receive |
|---|---|---|
| Pacebo pill and Diclofenac Eye Drops | Active comparator | Pacebo pill will be administered 4 hours before the IVI and one drop of Diclofenac 0.1% will be instilled 45' prior to the IVI. Receives: Drug: Diclofenac Eye Drops; Drug: Pacebo pill |
| Oral Diclofenac and Diclofenac Eye Drops | Active comparator | One Diclofenac Sodium sustained-release 75mg tablet administered per os 4 hours prior to the IVI and one drop of Diclofenac 0.1% will be instilled 45' prior to the IVI. Receives: Drug: Oral Diclofenac; Drug: Diclofenac Eye Drops |
| Pacebo pill and Artificial Tears | Placebo comparator | Pacebo pill will be administered 4 hours before the IVI and one drop Artificial Tears will be instilled 45' prior to the IVI. Receives: Drug: Pacebo pill; Drug: Artificial Tears |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of topical and oral Diclofenac's analgesic effect in patients undergoing intravitreal injections of anti-VEGFs as measured by the Visual Analogue Scale.
Measured: Immediately after injection
Secondary outcomes (5)
Assessment of topical and oral Diclofenac's analgesic effect in patients undergoing intravitreal injections of anti-VEGFs as measured by the Visual Analogue Scale.
Measured: Six hours after injection
Assessment of oral and topical Diclofenac's analgesic effect after intravitreal injections of anti-VEGFs as measured by the Main Component of the Short Form of the McGill Pain Questionnaire
Measured: Immediately after injection
Assessment of oral and topical Diclofenac's analgesic effect after intravitreal injections of anti-VEGFs as measured by the Main Component of the Short Form of the McGill Pain Questionnaire
Measured: Six hours after injection
Assessment of oral and topical Diclofenac's analgesic effect after intravitreal injections of anti-VEGFs as measured by the Present Pain Intensity score
Measured: Immediately after injection
Assessment of oral and topical Diclofenac's analgesic effect after intravitreal injections of anti-VEGFs as measured by the Present Pain Intensity score
Measured: Six hours after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionJan 2017
- Study completionJan 2017
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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of Patras
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Constantinos D. Georgakopoulos, MD, PhD, University Hospital of Patras
- Investigators
- Constantine Georgakopoulos, MD, Phd, Principal investigator, Associate Professor of Ophthalmology, Medical School, University of Patras, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02837770
- Sponsor's protocol ID
- 72/2016
- Status last verified
- Oct 2016
- First submitted
- 13 Jul 2016
- Last updated
- 10 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Effect of Topical and Oral Diclofenac on Pain Related to Intravitreal Injections, a Randomized, Triple-arm, Double-blind, Placebo-controlled Study.
- ClinicalTrials.gov ID
- NCT02837770
- Acronym / sponsor ID
- 72/2016
- Conditions
- Pain
- Keywords
- pain, intravitreal injection, anti-VEGF, diclofenac eye drops, oral diclofenac, Short Form of McGill Pain Questionnaire
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- University Hospital of PatrasUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 20 Jul 2016 (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.
The analgestic efffect of Diclofenac Sodium 0.1% Eye Drops and a combination of Diclofenac Sodium 0.1% Eye Drops and oral Diclofenac Sodium sustained-release 75mg tablets on pain related to intravitreal injections will be evalutated.
Pain perception will be assessed by the Short Form of the McGill Pain Questionnaire.
Detailed description
Intravitreal injection (IVI) is a preferred route of administration of drugs in the posterior segment of the eye. Intravitreal injection of anti-VEGFs constitutes the mainstay for the treatment of various retinal diseases such as AMD, RVO, DME etc.
The procedure of the IVI is, however, associated with a level of discomfort for the patient.
Nonsteroidal anti-inflammatory drugs (NSAIDs) inhibit the activity of cyclooxygenase-1 and cyclooxygenase-2, and thereby, the synthesis of prostaglandins and thromboxanes. Cyclooxygenase-2 inhibition leads to the anti-inflammatory, analgesic and antipyretic effects of NSAIDs.
Ophthalmic NSAIDs constitute an established and effective treatment option for the management of inflammation and pain associated with cataract surgery and of pain associated with corneal refractive surgery, for inhibition of intraoperative miosis and for the treatment of seasonal allergic conjunctivitis.
The primary goal of this study is to assess the analgesic effect of DIclofenac 0.1% Eye Drops a topical NSAID, as well as a combination of Diclofenac 0.1% Eye Drops and oral Diclofenac Sodium sustained-release (SR) 75mg tablets on pain related to intravitreal injections immediately after and up to six hours post-IVI.
A number of patients scheduled to undergo IVIs of anti-VEGFs will be randomized and divided in three groups. All patients must have already undergone at least one IVI. In patients receiving IVIs in both eyes only one eye will be included in the study.
The patients of the first group will receive placebo pill 4 hours before the IVI and Diclofenac 0.1 % Eye Drops 45 minutes prior to the injection.
The patients of the second group will recieve oral Diclofenac Sodium SR 75mg/tb 4 hours prior to the injection and Diclofenac 0.1% Eye Drops 45 minutes prior to the injection.
The patients of the third group will receive placebo pill 4 hours and Artificial Tears 45 minutes prior to the injection.
Patients will be required to complete the greek version of the short form McGill Pain Questionnaire (SF-MPQ) comprising of the Visual Analogue Scale, the main component of the SF-MPQ and the Present Pain Intensity Scale immediately after the injection and 6 hours post-IVI.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pacebo pill and Diclofenac Eye Drops | Active comparator | Drug: Diclofenac Eye Drops, Drug: Pacebo pillPacebo pill will be administered 4 hours before the IVI and one drop of Diclofenac 0.1% will be instilled 45' prior to the IVI. |
| Oral Diclofenac and Diclofenac Eye Drops | Active comparator | Drug: Oral Diclofenac, Drug: Diclofenac Eye DropsOne Diclofenac Sodium sustained-release 75mg tablet administered per os 4 hours prior to the IVI and one drop of Diclofenac 0.1% will be instilled 45' prior to the IVI. |
| Pacebo pill and Artificial Tears | Placebo comparator | Drug: Pacebo pill, Drug: Artificial TearsPacebo pill will be administered 4 hours before the IVI and one drop Artificial Tears will be instilled 45' prior to the IVI. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All participants will be patients of the Medical Retina Department of our Clinic, who are scheduled to receive IVIs of ranibizumab (Lucentis; Novartis Pharma S.A.S., Huningue, France) or aflibercept (Eylea; Bayer Healthcare Pharmaceuticals, Berlin, Germany) in one eye and had already undergone at least one IVI of an anti-VEGF agent.
Key exclusion criteria (3 listed)
- History of previous eye surgery other than cataract extraction surgery, herpetic eye disease, uncontrolled glaucoma, uveitis, active conjunctivitis, keratitis and bullous keratopathy, a previously known allergic response to diclofenac or other NSAIDs and salicylates, any contraindication to NSAIDs administration such as cardiovascular disease, gastrointenstinal disease with risk of GI ulceration,bleeding and perforation, renal and hepatic disease and any systemic or topical use of NSAIDs or any use of sedative medications within 7 days from the visit and during the day of IVI.
- Patients with poor cooperation in understanding and answering the questions of the SF-MPQ, including the visual analogue scale (VAS).
- Unsuccessful blinding
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 Eye DropsAlso: DENACLOF EY.DRO.SOL 0.1% (W/V)One drop of Diclofenac 0.1% will be instilled 45' prior to the IVI. | Drug | Pacebo pill and Diclofenac Eye Drops |
| Pacebo pillPacebo pill will be administered 4 hours before the IVI. | Drug | Pacebo pill and Diclofenac Eye Drops |
| Oral DiclofenacAlso: VOLTAREN S.R.F.C. 75MG/TABOne Diclofenac Sodium sustained-release 75mg tablet administered per os 4 hours prior to the IVI. | Drug | Oral Diclofenac and Diclofenac Eye Drops |
| Diclofenac Eye DropsAlso: DENACLOF EY.DRO.SOL 0.1% (W/V)One drop of Diclofenac 0.1% will be instilled 45' prior to the IVI. | Drug | Oral Diclofenac and Diclofenac Eye Drops |
| Pacebo pillPacebo pill will be administered 4 hours before the IVI. | Drug | Pacebo pill and Artificial Tears |
| Artificial TearsAlso: TEARS NATURALE 0,1%+0,3% EY.DRO.SOL.One drop Artificial Tears will be instilled 45' prior to the IVI. | Drug | Pacebo pill and Artificial Tears |
Primary outcome
Assessment of topical and oral Diclofenac's analgesic effect in patients undergoing intravitreal injections of anti-VEGFs as measured by the Visual Analogue Scale.
Time frame: Immediately after injection
5 secondary outcomes
Assessment of topical and oral Diclofenac's analgesic effect in patients undergoing intravitreal injections of anti-VEGFs as measured by the Visual Analogue Scale.
Time frame: Six hours after injection
Assessment of oral and topical Diclofenac's analgesic effect after intravitreal injections of anti-VEGFs as measured by the Main Component of the Short Form of the McGill Pain Questionnaire
Time frame: Immediately after injection
Assessment of oral and topical Diclofenac's analgesic effect after intravitreal injections of anti-VEGFs as measured by the Main Component of the Short Form of the McGill Pain Questionnaire
Time frame: Six hours after injection
Assessment of oral and topical Diclofenac's analgesic effect after intravitreal injections of anti-VEGFs as measured by the Present Pain Intensity score
Time frame: Immediately after injection
Assessment of oral and topical Diclofenac's analgesic effect after intravitreal injections of anti-VEGFs as measured by the Present Pain Intensity score
Time frame: Six hours after injection
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 10 Jan 2017.
- Individual participant dataSharing planned: Undecided
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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.
Constantine Georgakopoulos, MD, Phd principal investigator
Associate Professor of Ophthalmology, Medical School, University of Patras, Greece
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 Eye Drops, Pacebo pill and Oral Diclofenac in people with Pain, run by University Hospital of Patras at 1 site in Greece.
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 3 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 10 Jan 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 Greece. 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. Some participants in this study may receive a placebo. 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?
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?
Assessment of topical and oral Diclofenac's analgesic effect in patients undergoing intravitreal injections of anti-VEGFs as measured by the Visual Analogue Scale. (time frame: Immediately after injection). 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 10 Jan 2017.