Ocular Discomfort Assessment After Intravitreal Injections (EVAGO)

July 27, 2017 updated by: Oudy SEMOUN, Centre Hospitalier Intercommunal Creteil

Evaluation de la gêne Oculaire après Injections intravitréennes

In this study, ocular discomfort following intravitreal injection in naïve patients will be studied, as well as the efficacy of wetting agent (Optive eyewash) to prevent ocular discomfort.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In naive patients, the two first intravitreal injections will be studied. Within the first injection, no wetting agent will be delivered. Within 72hours after this first intravitreal injections, patients will be contacted by phone by a nurse to complete questionnaires on quality of life and on ocular pain and eye discomfort.

After the second injection, a treatment with wetting agent will be prescribed. With 72hours after the second injection, quality of life, ocular discomfort as well as acceptability and tolerance of the eye drops will also be assessed by a phone questionnaire.

Study Type

Interventional

Enrollment (Actual)

45

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

  • France
      • Creteil, France, 94000
        • Chi Creteil

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:

  • Patient over 18 years old
  • Patient with social healthcare
  • Patient understanding French language
  • Patient requiring anti-VEGF treatment by intravitreal injection

Exclusion Criteria:

  • Patient treated by Ozurdex® before
  • Patient with known and treated ocular dryness
  • Non naive patient for intravitreal injection
  • Hypersensitivity to Carmellose
  • Patient who received wetting agent within the 3 last months
  • History of povidone-iodine allergy
  • Pregnant or breastfeeding mother

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Optive after the second anti-VEGF injection
Naive patients requiring intravitreal injection. Patients will be enrolled in this study within the 2 first intravitreal injections to assess quality of life and ocular discomfort without wetting agent (ie after the first injection) and with wetting agent (ie after the second injection)
Drug: Optive
Optive eye drops will be prescribed to each included patients after their second intravitreal injection; patients will received 1 drop in the affected eye 2 times a day during 3 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Comparison of the overall scores of the ocular discomfort questionnaire after the 2 first intravitreal injection in naïve patients
Time Frame: within the 72h after the first and the second intravitreal injections
within the 72h after the first and the second intravitreal injections

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Intercommunal Creteil

Investigators

  • Principal Investigator: Oudy SEMOUN, MD, Chi Creteil

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (ACTUAL)

April 1, 2016

Primary Completion (ACTUAL)

January 1, 2017

Study Completion (ACTUAL)

July 1, 2017

Study Registration Dates

First Submitted

June 14, 2016

First Submitted That Met QC Criteria

June 20, 2016

First Posted (ESTIMATE)

June 21, 2016

Study Record Updates

Last Update Posted (ACTUAL)

July 28, 2017

Last Update Submitted That Met QC Criteria

July 27, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EVAGO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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