Senofilcon A Lenses in Moderate to Severe Dry Eye Disease

Not Applicable

• Conditions: Moderate to Severe Dry Eye Disease

• Registration Number: NCT04096898
• Lead Sponsor: University of Illinois at Chicago

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 symptoms.

Study Timeline

• Study Start: 2018-04-23
• Study First Submitted: 2019-09-18
• Study First Submitted QC: 2019-09-18
• Study First Posted: 2019-09-20
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-23
• Last Update Posted: 2020-03-24
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Ocular Surface Disease Index (OSDI)	2 weeks	Patient questionaire

Trial Locations

Locations (1)

University of Illinois at Chicago; 🇺🇸 Chicago, Illinois, United States