Mucin Levels in Dry Eye and Normal Populations

ORA, Inc.34 enrolled

Overview

The purpose of this study is to evaluate changes in ocular mucin levels in response to a drying environment in subjects with dry eye disease as well as patients who report no history of dry eye disease. It is expected that exposure to the dry environment will alter mucin levels in different ways when comparing the two groups.

This is a single-center, two visit, pilot, drying environment study (CAE). There will be two different groups of subjects enrolled into this study: dry eye subjects and subjects with no prior diagnosis of dry eye. All subjects will undergo safety and dry eye assessments as well as tear collection prior to and after being exposed to a dry environment. They will also return the following day to undergo dry eye assessments, tear collection, and safety procedures again.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Dry Eye

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Be male or female of any race, at least 18 years of age at Visit 1. * Have provided verbal and written informed consent. * Have a best corrected visual acuity of +0.70 logMAR or better in both eyes at Visit 1, as assessed by Early Treatment of Diabetic Retinopathy Study (ETDRS) chart. * If a woman of childbearing potential, have a negative urine pregnancy test at Visit 1 and agree to use a medically acceptable form of birth control throughout the study duration . \[Females are considered of childbearing potential unless they are surgically sterilized (bilateral tubal ligation, hysterectomy or bilateral oophorectomy) or post-menopausal (at least 12 months since last menses).\] * Have previously completed a recent trial OR not completed a recent trial AND report no symptoms of dry eye disease. Exclusion Criteria: * Have planned surgery during trial period * Female currently pregnant, planning a pregnancy or lactating * Use of disallowed medications * Have ocular infections, or ocular conditions that could affect study parameters * Have used an investigational drug or device within 30 days of start of study * Female that is currently pregnant, planning a pregnancy or lactating

Locations (1)

Andover Eye Associates

Andover, Massachusetts, United States

Outcomes

Primary Outcomes

Mucin levels assayed from collected tears

Tears will be collected and mucin will be measured after subjects are exposed to the CAE.

Time frame: 10-30 minutes Post CAE at Visit 1

Mucin levels assayed from collected tears

Tears will be collected and mucin will be measured 24 hours after being exposed to the CAE.

Time frame: 24 hours after being exposed to the CAE

Secondary Outcomes

Fluorescein staining

staining will be measured to detect presence of Superficial Punctate Keratitis and Confluency using Ora Calibra™ Corneal and Conjunctival Staining Scales

Time frame: pre-CAE

Fluorescein staining

Staining will be measured to detect presence of Superficial Punctate Keratitis and Confluency using Ora Calibra™ Corneal and Conjunctival Staining Scales

Time frame: 10-30 minutes Post CAE

Fluorescein staining

Staining will be measured measured to detect presence of Superficial Punctate Keratitis and Confluency using Ora Calibra™ Corneal and Conjunctival Staining Scales

Time frame: 24 hours post-CAE

Lissamine staining

Staining will be measured to detect presence of Superficial Punctate Keratitis and Confluency using Ora Calibra™ Corneal and Conjunctival Staining Scales

Time frame: pre-CAE

Lissamine staining

Staining will be measured to detect presence of Superficial Punctate Keratitis and Confluency using Ora Calibra™ Corneal and Conjunctival Staining Scales

Data from ClinicalTrials.gov

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