Mucin Levels in Dry Eye and Normal Populations

NCT05911555 | Completed

• 1 other identifier: 13-270-0004
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (22)

• Fluorescein staining

  pre-CAE

• Fluorescein staining

  10-30 minutes Post CAE

• Fluorescein staining

  24 hours post-CAE

• Lissamine staining

  pre-CAE

• Lissamine staining

  10-30 minutes Post CAE

Other Outcomes (5)

• Adverse Event Query

  Beginning of Visit 1 (Day 0)

• Adverse Event Query

  End of Visit 2 (Day 1)

• Best Corrected Visual Acuity

  Beginning and end of Visit 1 (Day 0)

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• ORA, Inc.: lead

Study Sites (1)

Andover Eye Associates

Andover, Massachusetts, 01810, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Tear collection

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Gail Torkildsen, MD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2013
• First Posted: June 22, 2023
• Study Start: May 1, 2013
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: June 22, 2023

Record last verified: 2023-06

Locations

US (1)