Comparison of the Efficacy of Nepafenac 0.1% and Nepafenac 0.3 % on Pain Associated With Intravitreal Injections

ID: NCT03406689
Status: Recruiting
Phase: N/A
Start Date: September 01, 2017
First Submitted: January 15, 2018
Last Updated: February 23, 2018
Results: N/A
Sponsors & Collaborators: University Hospital of Patras
Location: Greece
Conditions: Pain
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Study Description

Brief Summary

The analgestic efffect of Nepafenac 0.1% Eye Drops and Nepafenac 0.3% Eye Drops 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 Nepafenac 0.1% and Nepafenac 0.3% Eye Drops on pain related to intravitreal injections immediately after and up to six hours postIVI.

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 Nepafenac 0.1 % Eye Drops 45 minutes prior to the injection.

The patients of the second group will recieve Nepafenac 0.3 % Eye Drop 45 minutes prior to the injection. The patients of the third group will receive 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.
Condition or disease Intervention/treatment Phase

Pain

Drug: Nepafenac 0.1% Oph Susp
Other Names
NEVANAC EY.DRO.SUS 1MG/ML
Drug: Nepafenac 0.3% Oph Susp
Other Names
NEVANAC EY.DRO.SUS 3MG/ML
Drug: Artificial tear
Other Names
TEARS NATURALE EY.DRO.SOL 0,1%+0,3%
N/A

Tracking Information

First Submitted DateJanuary 15, 2018
Last Update Posted DateFebruary 23, 2018
Actual Start DateSeptember 01, 2017
Anticipated Completion DateFebruary 28, 2018
Actual Primary Completion DateFebruary 28, 2018
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • Assessment of topical Nepafenac 0.1% and Nepafenac 0.3% analgesic effect in patients undergoing intravitreal injections of anti-VEGFs [Time Frame: Immediately after the injection]

    As measured by the Visual Analogue Scale. The Visual Analogue Scale (abbreviation VAS) is a self report pain score chart designed as a 10 cm horizontal line marked at both ends. Each boundary of the line represents the extremes of painful experience (0=no pain and 10= the worst pain ever experienced). The patient is asked to mark on the scale the exact point corresponding to their perception of pain intensity and the score is calculated by measuring from the left hand side to the mark made by the patient, ranging from 0 to 10. Higher scores indicate more severe pain.

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

  • Assessment of topical Nepafenac 0.1% and Nepafenac 0.3% analgesic effect in patients undergoing intravitreal injections of anti-VEGFs [Time Frame: Six hours after injection]

    As measured by the Visual Analogue Scale. The Visual Analogue Scale (abbreviation VAS) is a self report pain score chart designed as a 10 cm horizontal line marked at both ends. Each boundary of the line represents the extremes of painful experience (0=no pain and 10= the worst pain ever experienced). The patient is asked to mark on the scale the exact point corresponding to their perception of pain intensity and the score is calculated by measuring from the left hand side to the mark made by the patient,ranging from 0 to 10. Higher scores indicate more severe pain.

  • Assessment of topical Nepafenac 0.1% and Nepafenac 0.3% analgesic effect in patients undergoing intravitreal injections of anti-VEGFs [Time Frame: Immediately after the injection]

    As measured by the Main Component of the Short Form of the McGill Pain Questionnaire. The main component of the Short form of the McGill Pain Questionnaire (abbreviation SF-MPQ) comprises of 15 adjectives describing the pain experienced (11 sensory and 4 affective). The patient is asked to grade the intensity of each specific pain quality on an intensity scale from 0 to 3 (0= none, 1=mild, 2=moderate, 3=severe). The total score of the main component is derived by adding the rank values given by the patient for each descriptor out of 45. Scores can range from 0 to 45. A higher score of the main component of the SF-MPQ reflects more serious pain.

  • Assessment of topical Nepafenac 0.1% and Nepafenac 0.3% analgesic effect in patients undergoing intravitreal injections of anti-VEGFs [Time Frame: Six hours after injection]

    As measured by the Main Component of the Short Form of the McGill Pain Questionnaire. The main component of the Short form of the McGill Pain Questionnaire (abbreviation SF-MPQ) comprises of 15 adjectives describing the pain experienced (11 sensory and 4 affective). The patient is asked to grade the intensity of each specific pain quality on an intensity scale from 0 to 3 (0= none, 1=mild, 2=moderate, 3=severe). The total score of the main component is derived by adding the rank values given by the patient for each descriptor out of 45. Scores can range from 0 to 45. A higher score of the main component of the SF-MPQ reflects more serious pain.

  • Assessment of topical Nepafenac 0.1% and Nepafenac 0.3% analgesic effect in patients undergoing intravitreal injections of anti-VEGFs [Time Frame: Immediately after the injection]

    As measured by the Present Pain Intensity score. The PPI index is a numerical verbal rating scale consisting of 6 adjectives of gradually increasing pain sensation (0, none; 1, mild; 2, discomforting; 3, distressing; 4, horrible; and 5, excruciating). The patient is instructed to choose the adjective indicating their pain state. The score for the PPI is derived from the number next to the patients' adjective of choice, ranging from 0 to 5. Higher scores indicate more intense pain.

  • Assessment of topical Nepafenac 0.1% and Nepafenac 0.3% analgesic effect in patients undergoing intravitreal injections of anti-VEGFs [Time Frame: Six hours after injection]

    As measured by the Present Pain Intensity score. The Present Pain Intensity (abbreviation PPI) index is a numerical verbal rating scale consisting of 6 adjectives of gradually increasing pain sensation (0, none; 1, mild; 2, discomforting; 3, distressing; 4, horrible; and 5, excruciating). The patient is instructed to choose the adjective indicating their pain state. The score for the PPI is derived from the number next to the patients' adjective of choice, ranging from 0 to 5. Higher scores indicate more intense pain.

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleComparison of the Efficacy of Nepafenac 0.1% and Nepafenac 0.3 % on Pain Associated With Intravitreal Injections
Official TitleComparison of the Efficacy of Nepafenac 0.1% and Nepafenac 0.3 % on Pain Associated With Intravitreal Injections, a Triple Arm Study
Brief Summary

The analgestic efffect of Nepafenac 0.1% Eye Drops and Nepafenac 0.3% Eye Drops 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 Nepafenac 0.1% and Nepafenac 0.3% Eye Drops on pain related to intravitreal injections immediately after and up to six hours postIVI.

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 Nepafenac 0.1 % Eye Drops 45 minutes prior to the injection.

The patients of the second group will recieve Nepafenac 0.3 % Eye Drop 45 minutes prior to the injection. The patients of the third group will receive 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 TypeInterventional
Study PhaseN/A
Estimated Enrollment
75
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
Triple
Primary Purpose
Supportive Care
Conditions
Pain
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Drug: Nepafenac 0.1% Oph Susp

One drop of Nepafenac 0.1% will be instilled 45' prior to the IVI.

Other Names
NEVANAC EY.DRO.SUS 1MG/ML
Drug: Nepafenac 0.3% Oph Susp

One drop of Nepafenac 0.3% will be instilled 45' prior to the IVI.

Other Names
NEVANAC EY.DRO.SUS 3MG/ML
Drug: Artificial tear

One drop Artificial Tears will be instilled 45' prior to the IVI.

Other Names
TEARS NATURALE EY.DRO.SOL 0,1%+0,3%
Study Groups/Cohorts
Nepafenac 0.1% Oph Susp
One drop of Nepafenac 0.1% will be administered 45' prior to the injection

Nepafenac 0.3% Oph Susp
One drop of Nepafenac 0.3% will be administered 45' prior to the injection

Artificial tears
One drop of Artificial Tears will be administered 45' prior to the injection

Study Arms
Placebo Comparator Artificial tears
One drop of Artificial Tears will be administered 45' prior to the injection
Drug : Artificial tear
One drop Artificial Tears will be instilled 45' prior to the IVI.

Active Comparator Nepafenac 0.1% Oph Susp
One drop of Nepafenac 0.1% will be administered 45' prior to the injection
Drug : Nepafenac 0.1% Oph Susp
One drop of Nepafenac 0.1% will be instilled 45' prior to the IVI.

Active Comparator Nepafenac 0.3% Oph Susp
One drop of Nepafenac 0.3% will be administered 45' prior to the injection
Drug : Nepafenac 0.3% Oph Susp
One drop of Nepafenac 0.3% will be instilled 45' prior to the IVI.

Arm Intervention/Treatment
Placebo Comparator Artificial tears
One drop of Artificial Tears will be administered 45' prior to the injection
Drug : Artificial tear
Active Comparator Nepafenac 0.1% Oph Susp
One drop of Nepafenac 0.1% will be administered 45' prior to the injection
Drug : Nepafenac 0.1% Oph Susp
Active Comparator Nepafenac 0.3% Oph Susp
One drop of Nepafenac 0.3% will be administered 45' prior to the injection
Drug : Nepafenac 0.3% Oph Susp

Recruitment Information

Recruitment Status:Recruiting
Enrollment75
Completion DateFebruary 28, 2018
Eligibility Criteria: 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 nepafenac 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
GenderAll
Age18 Years to N/A
Accepts Healthy VolunteersNo
Contacts
Listed Location Countries
Greece

Administrative Information

NCT Number:NCT03406689
Other Study ID Numbers
72/15.04.2016
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible PartyConstantinos D. Georgakopoulos, MD, PhD, University Hospital of Patras
Study Sponsor
University Hospital of Patras
Collaborators
Not Available
Investigators
Principal Investigator
Constantine Georgakopoulos, MD, PhD
Associate Professor of Ophthalmology, Medical School, University of Patras, Greece