Senofilcon A Lenses in Moderate to Severe Dry Eye Disease

Moderate to Severe Dry Eye Disease Clinical Trial

Official title:

Clinical Trial to Determine Whether Senofilcon A Lenses Provide Relief of Symptoms and Signs in Patients With Moderate to Severe Dry Eye Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04096898
• Other study ID #: 2017-0941
• Status: Recruiting
• Phase: N/A
• Start date: April 23, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: March 2020
• Source: University of Illinois at Chicago
• Contact: Timothy T McMahon, OD
• Phone: 312-996-5410
• Email: timomcma[@]uic.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca
• Moderate to Severe Dry Eye Disease

Intervention

Device:
• Senofilcon A contact lens
Senofilcon lenses will be tested in moderate to severe dry eye patients to determine their efficacy in reducing discomfort associated with dry eye.

Locations

Country	Name	City	State
United States	University of Illinois at Chicago	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Illinois at Chicago	Johnson & Johnson Vision Care, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ocular Surface Disease Index (OSDI)	Patient questionaire	2 weeks