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

NCT ID: NCT02821390

Last Updated: 2017-05-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2017-01-31

Brief Summary

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.

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.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Nepafenac Eye Drops

Intervention Type: DRUG

One drop instilled to the eye's cul de sac prior to the intravitreal injection.

Artificial Tears

One drop of Artificial Tears will be instilled to the eye's cul de sac prior to the intravitreal injection.

Group Type: PLACEBO_COMPARATOR

Placebo (Artificial Tears)

Intervention Type: DRUG

One drop instilled to the eye's cul de sac prior to the intravitreal injection

Interventions

Nepafenac Eye Drops

One drop instilled to the eye's cul de sac prior to the intravitreal injection.

Intervention Type: DRUG

Placebo (Artificial Tears)

One drop instilled to the eye's cul de sac prior to the intravitreal injection

Intervention Type: DRUG

Other Intervention Names

NEVANAC 0.1% Eye Drops; TEARS NATURALE 0.1%+0.3% Eye Drops

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 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital of Patras

OTHER

Sponsor Role: lead

Responsible Party

Constantinos D. Georgakopoulos, MD, PhD

Assoc. Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Constantine D Georgakopoulos, MD, Phd

Role: PRINCIPAL_INVESTIGATOR

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

Locations

University Hospital of Patras

Pátrai, Achaea, Greece

Countries

Greece

Other Identifiers

72/15.04.16

Identifier Type: -

Identifier Source: org_study_id