Mucin Levels in Dry Eye and Normal Populations

Dry Eye Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05911555
• Other study ID #: 13-270-0004
• Status: Completed
• Start date: May 2013
• Est. completion date: May 2013

Study information

• Verified date: June 2023
• Source: ORA, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Locations

Country	Name	City	State
United States	Andover Eye Associates	Andover	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
ORA, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	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)
Other	Best Corrected Visual Acuity	Best Corrected Visual Acuity	Beginning and end of Visit 1 (Day 0)
Other	Best Corrected Visual Acuity	Best Corrected Visual Acuity	Beginning of Visit 2 (Day 1)
Other	Urine Pregnancy test	Urine Pregnancy test	Beginning of Visit 1 (Day 0)
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Presence of conjunctival redness	conjunctival redness will be assessed by Ora Calibra™ Conjunctival Redness Scale	pre-CAE
Secondary	Presence of conjunctival redness	conjunctival redness will be assessed by Ora Calibra™ Conjunctival Redness Scale	10-30 minutes Post CAE
Secondary	Presence of conjunctival redness	conjunctival redness will be assessed by Ora Calibra™ Conjunctival Redness Scale	24 hours post-CAE
Secondary	Tear Film Break Up Time	Tear Film Break Up Time	pre-CAE
Secondary	Tear Film Break Up Time	Tear Film Break Up Time	10-30 minutes Post CAE
Secondary	Tear Film Break Up Time	Tear Film Break Up Time	24 hours post-CAE
Secondary	Blink Rate Analysis	Blink Rate Analysis	pre-CAE
Secondary	Blink Rate Analysis	Blink Rate Analysis	10-30 minutes Post CAE
Secondary	Blink Rate Analysis	Blink Rate Analysis	24 hours post-CAE
Secondary	Symptom Collection	Symptom Collection	pre-CAE
Secondary	Symptom Collection	Symptom Collection	10-30 minutes Post CAE
Secondary	Symptom Collection	Symptom Collection	24 hours post-CAE
Secondary	Ora Calibra Ocular Protection Index 2.0	Ora Calibra Ocular Protection Index 2.0	pre-CAE
Secondary	Ora Calibra Ocular Protection Index 2.0	Ora Calibra Ocular Protection Index 2.0	10-30 minutes Post CAE
Secondary	Ora Calibra Ocular Protection Index 2.0	Ora Calibra Ocular Protection Index 2.0	24 hours post-CAE
Secondary	Schirmer's Test	Schirmer's Test	End of Visit 2 (Day 1 of study)