Effect of Topical Nepafenac 0.1% on Pain Related to Intravitreal Injections

May 4, 2017 updated by: Constantinos D. Georgakopoulos, MD, PhD, University Hospital of Patras

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

Completed

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

Interventional

Enrollment (Actual)

55

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
    • Achaea
      • Patras, Achaea, Greece, 26504
        • University Hospital of Patras

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
Drug: Nepafenac Eye Drops
One drop instilled to the eye's cul de sac prior to the intravitreal injection.
Other Names:
  • NEVANAC 0.1% Eye Drops
Placebo Comparator: Artificial Tears
One drop of Artificial Tears will be instilled to the eye's cul de sac prior to the intravitreal injection.
Drug: Placebo (Artificial Tears)
One drop instilled to the eye's cul de sac prior to the intravitreal injection
Other Names:
  • TEARS NATURALE 0.1%+0.3% Eye Drops

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
Immediately and 6 hours after injection

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

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital of Patras

Investigators

  • Principal Investigator: Constantine D Georgakopoulos, MD, Phd, Associate Professor of Ophthalmology, Medical School, University of Patras, Greece

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

June 27, 2016

First Submitted That Met QC Criteria

June 28, 2016

First Posted (Estimate)

July 1, 2016

Study Record Updates

Last Update Posted (Actual)

May 5, 2017

Last Update Submitted That Met QC Criteria

May 4, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

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)?

Undecided

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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