Mucin Levels in Dry Eye and Normal Populations

A Single-Center Pilot Study To Evaluate the Effects of a Challenge Model on Mucin 16 Levels in Dry Eye Subjects Compared to Normal Subjects

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.

Study Overview

• Status: Completed
• Conditions: Dry Eye

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 Type: Observational
• Enrollment (Actual): 34

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Andover, Massachusetts, United States, 01810
      • Andover Eye Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Subjects with dry eye will be selected from a previous trial and subjects without dry eye will be also be enrolled.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Non-Dry Eye Subjects; Subjects with no reported history of dry eye disease will be enrolled
Dry Eye Disease; Subjects who have been diagnosed with dry eye disease in a previous trial will be enrolled.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mucin levels assayed from collected tears	Tears will be collected and mucin will be measured after subjects are exposed to the CAE.	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.	24 hours after being exposed to the CAE

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fluorescein staining	staining will be measured to detect presence of Superficial Punctate Keratitis and Confluency using Ora Calibra™ Corneal and Conjunctival Staining Scales	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	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	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	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	10-30 minutes 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	24 hours post-CAE
Presence of conjunctival redness	conjunctival redness will be assessed by Ora Calibra™ Conjunctival Redness Scale	pre-CAE
Presence of conjunctival redness	conjunctival redness will be assessed by Ora Calibra™ Conjunctival Redness Scale	10-30 minutes Post CAE
Presence of conjunctival redness	conjunctival redness will be assessed by Ora Calibra™ Conjunctival Redness Scale	24 hours post-CAE
Tear Film Break Up Time	Tear Film Break Up Time	pre-CAE
Tear Film Break Up Time	Tear Film Break Up Time	10-30 minutes Post CAE
Tear Film Break Up Time	Tear Film Break Up Time	24 hours post-CAE
Blink Rate Analysis	Blink Rate Analysis	pre-CAE
Blink Rate Analysis	Blink Rate Analysis	10-30 minutes Post CAE
Blink Rate Analysis	Blink Rate Analysis	24 hours post-CAE
Symptom Collection	Symptom Collection	pre-CAE
Symptom Collection	Symptom Collection	10-30 minutes Post CAE
Symptom Collection	Symptom Collection	24 hours post-CAE
Ora Calibra Ocular Protection Index 2.0	Ora Calibra Ocular Protection Index 2.0	pre-CAE
Ora Calibra Ocular Protection Index 2.0	Ora Calibra Ocular Protection Index 2.0	10-30 minutes Post CAE
Ora Calibra Ocular Protection Index 2.0	Ora Calibra Ocular Protection Index 2.0	24 hours post-CAE
Schirmer's Test	Schirmer's Test	End of Visit 2 (Day 1 of study)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Event Query	All adverse events that are reported during these visits will be followed up on until they are resolved or stabilized	Beginning of Visit 1 (Day 0)
Adverse Event Query	All adverse events that are reported during these visits will be followed up on until they are resolved or stabilized	End of Visit 2 (Day 1)
Best Corrected Visual Acuity	Best Corrected Visual Acuity	Beginning and end of Visit 1 (Day 0)
Best Corrected Visual Acuity	Best Corrected Visual Acuity	Beginning of Visit 2 (Day 1)
Urine Pregnancy test	Urine Pregnancy test	Beginning of Visit 1 (Day 0)

Collaborators and Investigators

• Sponsor: ORA, Inc.
• Investigators: Principal Investigator: Gail Torkildsen, MD

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: July 30, 2013
• First Submitted That Met QC Criteria: June 15, 2023
• First Posted (Actual): June 22, 2023

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 15, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca
• Other Study ID Numbers: 13-270-0004