Comparison of Diclofenac vs. Nepafenac Ophthalmic Drops:... | NCT02506348

Studies
Comparison of Diclofenac vs. Nepafenac Ophthalmic Drops: Patient Comfort

NCT02506348

Sponsor

Wolfson Medical Center

Status

Unknown status

Last Update Posted

Jul 24, 2015Estimated

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Post Surgical Management
Pain Management
Inflamation Management

Interventions

Diclofenac
Nepafenac

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2015

Primary Completion Date

Jan 2016Estimated

Completion Date

Not provided

First Submitted Date

Jul 2, 2015

First Submission Date that Met QC Criteria

Jul 21, 2015

First Posted Date

Jul 23, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 22, 2015

Last Update Posted Date

Jul 24, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

In this study we test Diclofenac and Nepafenac and compared patients experience and comfort following administration of these ophthalmic drops.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Diclofenac+Nepafenac	Experimental	one drop Diclofenac in one eye one drop Nepafenac in other eye	Drug: Diclofenac Drug: Nepafenac

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Diclofenac	Drug		Diclofenac+Nepafenac
Nepafenac

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patient facing cataract surgery

Exclusion Criteria:

under 18
cognitive decline

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The E.Wolfson Medical Center	Recruiting	Holon		58100	Israel

Condition Browse Module

MeSH Terms

ID	Term
D000377	Agnosia

Ancestor Terms

ID	Term
D010468	Perceptual Disorders
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004008	Diclofenac
C414203	nepafenac

Ancestor Terms

ID	Term
D010648	Phenylacetates
D000146	Acids, Carbocyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided