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

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ClinicalTrials.gov Identifier: NCT02837770
Recruitment Status : Completed
First Posted : July 20, 2016
Last Update Posted : January 10, 2017
Sponsor:
Information provided by (Responsible Party):
Constantinos D. Georgakopoulos, MD, PhD, University Hospital of Patras

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.


Condition or disease Intervention/treatment Phase
Pain Drug: Diclofenac Eye Drops Drug: Pacebo pill Drug: Oral Diclofenac Drug: Artificial Tears Not Applicable

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 DIclofenac 0.1% Eye Drops a topical NSAID, as well as a combination of Diclofenac 0.1% Eye Drops and oral Diclofenac Sodium sustained-release (SR) 75mg tablets on pain related to intravitreal injections immediately after and up to six hours post-IVI.

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 placebo pill 4 hours before the IVI and Diclofenac 0.1 % Eye Drops 45 minutes prior to the injection.

The patients of the second group will recieve oral Diclofenac Sodium SR 75mg/tb 4 hours prior to the injection and Diclofenac 0.1% Eye Drops 45 minutes prior to the injection.

The patients of the third group will receive placebo pill 4 hours and 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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Analgesic Effect of Topical and Oral Diclofenac on Pain Related to Intravitreal Injections, a Randomized, Triple-arm, Double-blind, Placebo-controlled Study.
Study Start Date : July 2016
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Pacebo pill and Diclofenac Eye Drops
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
One drop of Diclofenac 0.1% will be instilled 45' prior to the IVI.
Other Name: DENACLOF EY.DRO.SOL 0.1% (W/V)

Drug: Pacebo pill
Pacebo pill will be administered 4 hours before the IVI.

Active Comparator: Oral Diclofenac and Diclofenac Eye Drops
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
One Diclofenac Sodium sustained-release 75mg tablet administered per os 4 hours prior to the IVI.
Other Name: VOLTAREN S.R.F.C. 75MG/TAB

Drug: Diclofenac Eye Drops
One drop of Diclofenac 0.1% will be instilled 45' prior to the IVI.
Other Name: DENACLOF EY.DRO.SOL 0.1% (W/V)

Placebo Comparator: Pacebo pill and Artificial Tears
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
Pacebo pill will be administered 4 hours before the IVI.

Drug: Artificial Tears
One drop Artificial Tears will be instilled 45' prior to the IVI.
Other Name: TEARS NATURALE 0,1%+0,3% EY.DRO.SOL.




Primary Outcome Measures :
  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. [ Time Frame: Immediately after injection ]

Secondary Outcome Measures :
  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. [ Time Frame: Six hours after injection ]
  2. 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 [ Time Frame: Immediately after injection ]
  3. 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 [ Time Frame: Six hours after injection ]
  4. Assessment of oral and topical Diclofenac's analgesic effect after intravitreal injections of anti-VEGFs as measured by the Present Pain Intensity score [ Time Frame: Immediately after injection ]
  5. Assessment of oral and topical Diclofenac's analgesic effect after intravitreal injections of anti-VEGFs as measured by the Present Pain Intensity score [ Time Frame: Six hours after injection ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02837770


Locations
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Greece
University Hospital of Patras
Patra, Achaea, Greece, 26504
Sponsors and Collaborators
University Hospital of Patras
Investigators
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Principal Investigator: Constantine Georgakopoulos, MD, Phd Associate Professor of Ophthalmology, Medical School, University of Patras, Greece

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Responsible Party: Constantinos D. Georgakopoulos, MD, PhD, Associate Professor of Ophthalmology, University Hospital of Patras
ClinicalTrials.gov Identifier: NCT02837770     History of Changes
Other Study ID Numbers: 72/2016
First Posted: July 20, 2016    Key Record Dates
Last Update Posted: January 10, 2017
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Constantinos D. Georgakopoulos, MD, PhD, University Hospital of Patras:
pain
intravitreal injection
anti-VEGF
diclofenac eye drops
oral diclofenac
Short Form of McGill Pain Questionnaire
Additional relevant MeSH terms:
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Diclofenac
Ophthalmic Solutions
Lubricant Eye Drops
Pharmaceutical Solutions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action