Senofilcon A Lenses in Moderate to Severe Dry Eye Disease

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04096898

Enrollment

Registered

2019-09-20

Start date

2018-04-23

Completion date

2020-12-31

Last updated

2020-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Moderate to Severe Dry Eye Disease

Keywords

dry eye

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.

Interventions

DEVICESenofilcon 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

TRIPLE (Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Ocular Surface Disease Index (OSDI)	2 weeks	Patient questionaire

Countries

United States

Contacts

Primary ContactTimothy T McMahon, OD

timomcma@uic.edu312-996-5410

Backup ContactJacob Merriman

jmerr@uic.edu312-996-8041

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026