Senofilcon A Lenses in Moderate to Severe Dry Eye Disease | NCT04096898

Studies
Senofilcon A Lenses in Moderate to Severe Dry Eye Disease

NCT04096898

Sponsor

University of Illinois at Chicago

Status

Unknown status

Last Update Posted

Mar 24, 2020Actual

Enrollment

32Estimated

Phase

Not Applicable

Conditions

Moderate to Severe Dry Eye Disease

Interventions

Senofilcon A contact lens

Countries

United States

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

Mar 2020

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

Apr 23, 2018Actual

Primary Completion Date

Dec 31, 2020Estimated

Completion Date

Dec 31, 2020Estimated

First Submitted Date

Sep 18, 2019

First Submission Date that Met QC Criteria

Sep 18, 2019

First Posted Date

Sep 20, 2019Actual

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

Mar 23, 2020

Last Update Posted Date

Mar 24, 2020Actual

Name	Class
Johnson & Johnson Vision Care, Inc.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

A clinical trial using Senofilcon A daily lenses in the treatment of moderate to severe dry eye. This a comparison between signs and symptoms prior to and during treatment.

Detailed Description

32 patients with moderate to severe dry eye will be enrolled in this short-term proof of concept study to determine the efficacy in using soft lenses made of Senofilcon A in reducing signs and symptoms.

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

32Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Senofilcon A contact lens	Device	Senofilcon lenses will be tested in moderate to severe dry eye patients to determine their efficacy in reducing discomfort associated with dry eye.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Ocular Surface Disease Index (OSDI)	Patient questionaire	2 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Confirmed diagnosis of moderate to severe dry eye associated with either Graft-versus-host disease (GVHD), Sjogren syndrome, idiopathic dry eyes, or minimal limbal cell deficiency
A baseline Schirmer tear test (1) of less than 5 mm at 5 minutes without anesthesia
Have a visual analog score for comfort of 50 or less (scale of 1-100, with 100 meaning perfect ocular comfort and 1 meaning severe ocular pain)
Ability or the resources to insert and remove the study lenses
An OSDI score greater than 42
A willingness to sign an informed consent

Exclusion Criteria:

No dry eyes or mild dry eyes
A baseline Schirmer tear test (1) of greater than 5 mm of wetting at 5 minutes
Dry eye comfort score of greater than 50 on a visual analog scale
Unable to insert or remove the study lenses (or have a family member do so)
Have an OSDI score less than 42
Has been diagnosed with neurotrophic keratopathy in either eye
Unwilling to enroll in the study, and unwilling to provide signed informed consent to participate in the study

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

Name	Role	Phone	Extension	Email
Timothy T McMahon, OD	Contact	312-996-5410		timomcma@uic.edu
Jacob Merriman	Contact	312-996-8041		jmerr@uic.edu

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Illinois at Chicago	Recruiting	Chicago	Illinois	60612	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D007766	Lacrimal Apparatus Diseases
D005128	Eye Diseases