NCT02821390

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable pain

Timeline
Completed

Started Jun 2016

Shorter than P25 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

June 27, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 1, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

May 5, 2017

Status Verified

May 1, 2017

Enrollment Period

7 months

First QC Date

June 27, 2016

Last Update Submit

May 4, 2017

Conditions

Pain

Keywords

intravitreal injectionpainnon-steroidal anti-inflammatory drugsanti-VEGFnepafenac

Outcome Measures

Primary Outcomes (1)

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

    Immediately and 6 hours after injection

Secondary Outcomes (2)

  • 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

    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

    Immediately and 6 hours after injection

Study Arms (2)

Nepafenac 0.1% Eye Drops

ACTIVE COMPARATOR

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

Artificial Tears

PLACEBO COMPARATOR

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

Drug: Placebo (Artificial Tears)

Interventions

Nepafenac Eye DropsDRUG

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

Also known as: NEVANAC 0.1% Eye Drops
Nepafenac 0.1% Eye Drops
Placebo (Artificial Tears)DRUG

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

Also known as: TEARS NATURALE 0.1%+0.3% Eye Drops
Artificial Tears

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Patras

Pátrai, Achaea, 26504, Greece

Location

MeSH Terms

Conditions

Pain

Interventions

nepafenacOphthalmic SolutionsLubricant Eye Drops

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pharmaceutical SolutionsSolutionsPharmaceutical PreparationsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesSpecialty Uses of ChemicalsLubricants

Study Officials

  • Constantine D 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
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Professor

Study Record Dates

First Submitted

June 27, 2016

First Posted

July 1, 2016

Study Start

June 1, 2016

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

May 5, 2017

Record last verified: 2017-05

Locations

GR(1)