Senofilcon A Lenses in Moderate to Severe Dry Eye Disease
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Know the risks and potential benefits of clinical studies and talk to your health care provider before participating.
Read our disclaimer for details.
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.
Condition or disease
Moderate to Severe Dry Eye Disease
Device: Senofilcon A contact lens
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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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