Senofilcon A Lenses in Moderate to Severe Dry Eye Disease

University of Illinois

Status

Unknown

Conditions

Moderate to Severe Dry Eye Disease

Treatments

Device: Senofilcon A contact lens

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04096898

2017-0941

Details and patient eligibility

About

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.

Full 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.

Enrollment

32 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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