NCT04096898

Unknown

Senofilcon A Lenses in Moderate to Severe Dry Eye Disease

University of Illinois at Chicago Source

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Other study identifiers

Sponsor study identifier

2017-0941

Study Type

interventional

Estimated enrollment

32

Locations

1 country

Sites

1

Timeline

Study Start

April 23, 2018

Actual (reported)

Primary Completion

December 31, 2020

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

December 31, 2020

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: unknown
Estimated enrollment: 32 participants
Study completion date: December 31, 2020
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Listed locations: 1 countries · 1 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
April 23, 2018
Actual (reported)
First Submitted
September 18, 2019
Actual (reported)
First Posted
September 20, 2019
Actual (reported)
Primary Completion
December 31, 2020
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2020
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated: March 24, 2020
Status Verified: March 2020
Last Update Submitted: March 23, 2020

Conditions

Moderate to Severe Dry Eye Disease

Keywords

dry eye

Outcome Measures

Primary Outcomes (1)

Ocular Surface Disease Index (OSDI)
Patient questionaire
2 weeks

Interventions

Senofilcon A contact lensDevice

Senofilcon lenses will be tested in moderate to severe dry eye patients to determine their efficacy in reducing discomfort associated with dry eye.

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

University of Illinois at Chicago
Otherlead
Johnson & Johnson Vision Care, Inc.
Industrycollaborator

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

RECRUITING

Jacob MerrimanCONTACT312-996-8041 jmerr@uic.edu

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Central Study Contacts

Timothy T McMahon, OD

CONTACT

312-996-5410 timomcma@uic.edu

Jacob Merriman

CONTACT

312-996-8041

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NA
Masking: TRIPLE
Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Dr. Timothy T. McMahon

Study Record Dates

First Submitted

September 18, 2019

First Posted

September 20, 2019

Study Start

April 23, 2018

Actual (reported)

Primary Completion

December 31, 2020

Estimated (date passed)

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

jmerr@uic.edu

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

December 31, 2020

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated

March 24, 2020

Record last verified: 2020-03

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT04096898
Data provider: ClinicalTrials.gov
Source updated: 2020-03-24
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:36:20 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations