Senofilcon A Lenses in Moderate to Severe Dry Eye Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-23

Study Completion Date

2020-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Moderate to Severe Dry Eye Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No