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

NCT03406689 | Completed

• 1 other identifier: 72/15.04.2016
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

Pain; Intravitreal Injection; Anti-VEGF; Nepafenac eye drops; Short Form McGill Pain Questionnaire

Outcome Measures

Primary Outcomes (1)

• Assessment of topical Nepafenac 0.1% and Nepafenac 0.3% analgesic effect in patients undergoing intravitreal injections of anti-VEGFs

  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.

  Immediately after the injection

Secondary Outcomes (5)

• Assessment of topical Nepafenac 0.1% and Nepafenac 0.3% analgesic effect in patients undergoing intravitreal injections of anti-VEGFs

  Six hours after injection

• Assessment of topical Nepafenac 0.1% and Nepafenac 0.3% analgesic effect in patients undergoing intravitreal injections of anti-VEGFs

  Immediately after the injection

• Assessment of topical Nepafenac 0.1% and Nepafenac 0.3% analgesic effect in patients undergoing intravitreal injections of anti-VEGFs

  Six hours after injection

• Assessment of topical Nepafenac 0.1% and Nepafenac 0.3% analgesic effect in patients undergoing intravitreal injections of anti-VEGFs

  Immediately after the injection

• Assessment of topical Nepafenac 0.1% and Nepafenac 0.3% analgesic effect in patients undergoing intravitreal injections of anti-VEGFs

  Six hours after injection

Study Arms (3)

Nepafenac 0.1% Oph Susp

ACTIVE COMPARATOR

One drop of Nepafenac 0.1% will be administered 45' prior to the injection

Drug: Nepafenac 0.1% Oph Susp

Nepafenac 0.3% Oph Susp

ACTIVE COMPARATOR

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

Drug: Nepafenac 0.3% Oph Susp

Artificial tears

PLACEBO COMPARATOR

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

Drug: Artificial tear

Interventions

Nepafenac 0.1% Oph Susp DRUG

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

Also known as: NEVANAC EY.DRO.SUS 1MG/ML

Nepafenac 0.1% Oph Susp

Nepafenac 0.3% Oph Susp DRUG

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

Also known as: NEVANAC EY.DRO.SUS 3MG/ML

Nepafenac 0.3% Oph Susp

Artificial tear DRUG

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

Also known as: TEARS NATURALE EY.DRO.SOL 0,1%+0,3%

Artificial tears

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital of Patras: lead

Study Sites (1)

University Hospital of Patras

Pátrai, Achaia, 26504, Greece

Location

MeSH Terms

Conditions

Pain

Interventions

nepafenac; Lubricant Eye Drops

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ophthalmic Solutions; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Lubricants; Specialty Uses of Chemicals

Study Officials

• Constantine Georgakopoulos, MD, PhD

  Associate Professor of Ophthalmology, Medical School, University of Patras, Greece

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor in Ophthalmology

Study Record Dates

• First Submitted: January 15, 2018
• First Posted: January 23, 2018
• Study Start: September 1, 2017
• Primary Completion: February 28, 2018
• Study Completion: March 28, 2018
• Last Updated: April 4, 2018

Record last verified: 2018-04

Locations

GR (1)