Mucin Levels in Dry Eye and Normal Populations

Completed

• Conditions: Dry Eye

• Registration Number: NCT05911555
• Lead Sponsor: ORA, Inc.

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2013-05
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Study First Submitted: 2013-07-30
• Status Verified: 2023-06
• Study First Submitted QC: 2023-06-15
• Last Update Submitted: 2023-06-15
• Study First Posted: 2023-06-22
• Last Update Posted: 2023-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mucin levels assayed from collected tears	24 hours after being exposed to the CAE	Tears will be collected and mucin will be measured 24 hours after being exposed to the CAE.

Secondary Outcome Measures

Name	Time	Method
Blink Rate Analysis	24 hours post-CAE	Blink Rate Analysis
Symptom Collection	24 hours post-CAE	Symptom Collection
Schirmer's Test	End of Visit 2 (Day 1 of study)	Schirmer's Test
Fluorescein staining	24 hours post-CAE	Staining will be measured measured to detect presence of Superficial Punctate Keratitis and Confluency using Ora Calibra™ Corneal and Conjunctival Staining Scales
Tear Film Break Up Time	24 hours post-CAE	Tear Film Break Up Time
Lissamine staining	24 hours post-CAE	Staining will be measured to detect presence of Superficial Punctate Keratitis and Confluency using Ora Calibra™ Corneal and Conjunctival Staining Scales
Presence of conjunctival redness	24 hours post-CAE	conjunctival redness will be assessed by Ora Calibra™ Conjunctival Redness Scale
Ora Calibra Ocular Protection Index 2.0	24 hours post-CAE	Ora Calibra Ocular Protection Index 2.0

Trial Locations

Locations (1)

Andover Eye Associates; 🇺🇸 Andover, Massachusetts, United States