Effect of Topical and Oral Diclofenac on Pain Related to Intravitreal Injections

NCT02837770 | Completed

• 1 other identifier: 72/2016
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

The analgestic efffect of Diclofenac Sodium 0.1% Eye Drops and a combination of Diclofenac Sodium 0.1% Eye Drops and oral Diclofenac Sodium sustained-release 75mg tablets 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; diclofenac eye drops; oral diclofenac; Short Form of McGill Pain Questionnaire

Outcome Measures

Primary Outcomes (1)

• Assessment of topical and oral Diclofenac's analgesic effect in patients undergoing intravitreal injections of anti-VEGFs as measured by the Visual Analogue Scale.

  Immediately after injection

Secondary Outcomes (5)

• Assessment of topical and oral Diclofenac's analgesic effect in patients undergoing intravitreal injections of anti-VEGFs as measured by the Visual Analogue Scale.

  Six hours after injection

• Assessment of oral and topical Diclofenac's analgesic effect after intravitreal injections of anti-VEGFs as measured by the Main Component of the Short Form of the McGill Pain Questionnaire

  Immediately after injection

• Assessment of oral and topical Diclofenac's analgesic effect after intravitreal injections of anti-VEGFs as measured by the Main Component of the Short Form of the McGill Pain Questionnaire

  Six hours after injection

• Assessment of oral and topical Diclofenac's analgesic effect after intravitreal injections of anti-VEGFs as measured by the Present Pain Intensity score

  Immediately after injection

• Assessment of oral and topical Diclofenac's analgesic effect after intravitreal injections of anti-VEGFs as measured by the Present Pain Intensity score

  Six hours after injection

Study Arms (3)

Pacebo pill and Diclofenac Eye Drops

ACTIVE COMPARATOR

Pacebo pill will be administered 4 hours before the IVI and one drop of Diclofenac 0.1% will be instilled 45' prior to the IVI.

Drug: Diclofenac Eye Drops; Drug: Pacebo pill

Oral Diclofenac and Diclofenac Eye Drops

ACTIVE COMPARATOR

One Diclofenac Sodium sustained-release 75mg tablet administered per os 4 hours prior to the IVI and one drop of Diclofenac 0.1% will be instilled 45' prior to the IVI.

Drug: Oral Diclofenac; Drug: Diclofenac Eye Drops

Pacebo pill and Artificial Tears

PLACEBO COMPARATOR

Pacebo pill will be administered 4 hours before the IVI and one drop Artificial Tears will be instilled 45' prior to the IVI.

Drug: Pacebo pill; Drug: Artificial Tears

Interventions

Diclofenac Eye Drops DRUG

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

Also known as: DENACLOF EY.DRO.SOL 0.1% (W/V)

Pacebo pill and Diclofenac Eye Drops

Pacebo pill DRUG

Pacebo pill will be administered 4 hours before the IVI.

Pacebo pill and Diclofenac Eye Drops

Oral Diclofenac DRUG

One Diclofenac Sodium sustained-release 75mg tablet administered per os 4 hours prior to the IVI.

Also known as: VOLTAREN S.R.F.C. 75MG/TAB

Oral Diclofenac and Diclofenac Eye Drops

Artificial Tears DRUG

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

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

Pacebo pill and 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 diclofenac 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, Achaea, 26504, Greece

Location

MeSH Terms

Conditions

Pain

Interventions

Diclofenac; Lubricant Eye Drops

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; 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 of Ophthalmology

Study Record Dates

• First Submitted: July 13, 2016
• First Posted: July 20, 2016
• Study Start: July 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: January 10, 2017

Record last verified: 2016-10

Locations

GR (1)