Senofilcon A Lenses in Moderate to Severe Dry Eye Disease
Clinical Trial to Determine Whether Senofilcon A Lenses Provide Relief of Symptoms and Signs in Patients With Moderate to Severe Dry Eye Disease
1 other identifier
interventional
32
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 23, 2018
CompletedFirst Submitted
Initial submission to the registry
September 18, 2019
CompletedFirst Posted
Study publicly available on registry
September 20, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedMarch 24, 2020
March 1, 2020
2.7 years
September 18, 2019
March 23, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Ocular Surface Disease Index (OSDI)
Patient questionaire
2 weeks
Interventions
Senofilcon lenses will be tested in moderate to severe dry eye patients to determine their efficacy in reducing discomfort associated with dry eye.
Eligibility Criteria
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
- 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.
Sponsors & Collaborators
Study Sites (1)
University of Illinois at Chicago
Chicago, Illinois, 60612, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
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
Primary Completion
December 31, 2020
Study Completion
December 31, 2020
Last Updated
March 24, 2020
Record last verified: 2020-03