Status:
UNKNOWN
Senofilcon A Lenses in Moderate to Severe Dry Eye Disease
Lead Sponsor:
University of Illinois at Chicago
Collaborating Sponsors:
Johnson & Johnson Vision Care, Inc.
Conditions:
Moderate to Severe Dry Eye Disease
Eligibility:
All Genders
18+ years
Phase:
NA
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 symptom...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 23 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2020
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT04096898
Start Date
April 23 2018
End Date
December 31 2020
Last Update
March 24 2020
Active Locations (1)
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1
University of Illinois at Chicago
Chicago, Illinois, United States, 60612