Comparison of Diclofenac vs. Nepafenac Ophthalmic Drops: Patient Comfort

July 22, 2015 updated by: Asaf Achiron, Wolfson Medical Center
In this study we test Diclofenac and Nepafenac and compared patients experience and comfort following administration of these ophthalmic drops.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

In this study we will compare the ocular tolerability between preservative-free Diclofenac and Nepafenac drops. Using a standard comparative scale we will measured discomfort, itching, burning and pain in intervals of 1 sec, 5 sec, 1 min and 5 min post-administration.

The results may aid both doctors and patients in decision regarding the post surgical anti-inflammatory treatment.

Study Type

Interventional

Enrollment (Anticipated)

30

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

  • Israel
      • Holon, Israel, 58100
        • Recruiting
        • The E.Wolfson Medical Center
        • Contact:
          • Asaf Achiron, MD
          • Phone Number: +97235028706
        • Contact:

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 facing cataract surgery

Exclusion Criteria:

  • under 18
  • cognitive decline

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

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Diclofenac+Nepafenac
one drop Diclofenac in one eye one drop Nepafenac in other eye
Drug: Diclofenac
Drug: Nepafenac

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
patient's comfort
Time Frame: 1 min post administration
change in patient's comfort between both eyes at 1 min post administration
1 min post administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
patient's comfort
Time Frame: 5 min post administration
change in patient's comfort between both eyes at 10 min post administration
5 min post administration

Collaborators and Investigators

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

Sponsor

Wolfson Medical Center

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

July 1, 2015

Primary Completion (Anticipated)

January 1, 2016

Study Registration Dates

First Submitted

July 2, 2015

First Submitted That Met QC Criteria

July 21, 2015

First Posted (Estimate)

July 23, 2015

Study Record Updates

Last Update Posted (Estimate)

July 24, 2015

Last Update Submitted That Met QC Criteria

July 22, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0011-15

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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