- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02821390
Effect of Topical Nepafenac 0.1% on Pain Related to Intravitreal Injections
Analgesic Effect Of Topical Nepafenac 0.1% On Pain Related To Intravitreal Injections: A Randomized Crossover Study
The analgesic effect of Nepafenac 0.1% Ophthalmic Drops on ocular pain related to intravitreal injections will be evaluated.
Pain perception will be assessed by the Short Form of the McGill Pain Questionnaire.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Ophthalmic nonsteroidal anti-inflammatory drugs (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 Nepafenac 0.1% Eye Drops a topical NSAID on pain related to intravitreal injections immediately after and up to six hours post-IVI.
A number of patients scheduled to undergo IVIs will be divided in two 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 be randomized to receive Nepafenac 0.1% Eye Drops in the first appointment and then crossover to receive the placebo (Artificial Tears) in their next appointment for an IVI.
The patients of the second will be randomized to receive the placebo (Artificial Tears) in the first appointment and then crossover to receive Nepafenac 0.1% Eye Drops in their next appointment for an IVI.
All drugs will be administered prior to the injection by a member of the Department's personnel (a staff nurse).
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Achaea
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Patras, Achaea, Greece, 26504
- University Hospital of Patras
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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 bromfenac or other NSAIDs and salicylates, 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Nepafenac 0.1% Eye Drops
One drop of Nepafenac 0.1% Eye Drops will be instilled to the eye's cul de sac prior to the intravitreal injection.
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One drop instilled to the eye's cul de sac prior to the intravitreal injection.
Other Names:
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Placebo Comparator: Artificial Tears
One drop of Artificial Tears will be instilled to the eye's cul de sac prior to the intravitreal injection.
|
One drop instilled to the eye's cul de sac prior to the intravitreal injection
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Assessment of Nepafenac's analgesic effect in patients undergoing intravitreal injections of anti-VEGFs as measured by the Visual Analogue Scale.
Time Frame: Immediately and 6 hours after injection
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Immediately and 6 hours after injection
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Assessment of Nepafenac'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 and 6 hours after injection
|
Immediately and 6 hours after injection
|
Assessment of Nepafenac's analgesic effect after intravitreal injections of anti-VEGFs as measured by the main component of the Present Pain Intensity score
Time Frame: Immediately and 6 hours after injection
|
Immediately and 6 hours after injection
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Constantine D Georgakopoulos, MD, Phd, Associate Professor of Ophthalmology, Medical School, University of Patras, Greece
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 72/15.04.16
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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