Clincosm LogoSign in Get a demo

Mucin Levels in Dry Eye and Normal Populations

Sponsor
ORA, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT05911555
Collaborator
(none)
34
Enrollment
1
Location

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    34 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    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
    Study Start Date :
    May 1, 2013
    Actual Primary Completion Date :
    May 1, 2013
    Actual Study Completion Date :
    May 1, 2013

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Mucin levels assayed from collected tears [10-30 minutes Post CAE at Visit 1]

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

    2. 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

    1. Fluorescein staining [pre-CAE]

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

    2. Fluorescein staining [10-30 minutes Post CAE]

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

    3. 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

    4. Lissamine staining [pre-CAE]

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

    5. Lissamine staining [10-30 minutes Post CAE]

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

    6. 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

    7. Presence of conjunctival redness [pre-CAE]

      conjunctival redness will be assessed by Ora Calibra™ Conjunctival Redness Scale

    8. Presence of conjunctival redness [10-30 minutes Post CAE]

      conjunctival redness will be assessed by Ora Calibra™ Conjunctival Redness Scale

    9. Presence of conjunctival redness [24 hours post-CAE]

      conjunctival redness will be assessed by Ora Calibra™ Conjunctival Redness Scale

    10. Tear Film Break Up Time [pre-CAE]

      Tear Film Break Up Time

    11. Tear Film Break Up Time [10-30 minutes Post CAE]

      Tear Film Break Up Time

    12. Tear Film Break Up Time [24 hours post-CAE]

      Tear Film Break Up Time

    13. Blink Rate Analysis [pre-CAE]

      Blink Rate Analysis

    14. Blink Rate Analysis [10-30 minutes Post CAE]

      Blink Rate Analysis

    15. Blink Rate Analysis [24 hours post-CAE]

      Blink Rate Analysis

    16. Symptom Collection [pre-CAE]

      Symptom Collection

    17. Symptom Collection [10-30 minutes Post CAE]

      Symptom Collection

    18. Symptom Collection [24 hours post-CAE]

      Symptom Collection

    19. Ora Calibra Ocular Protection Index 2.0 [pre-CAE]

      Ora Calibra Ocular Protection Index 2.0

    20. Ora Calibra Ocular Protection Index 2.0 [10-30 minutes Post CAE]

      Ora Calibra Ocular Protection Index 2.0

    21. Ora Calibra Ocular Protection Index 2.0 [24 hours post-CAE]

      Ora Calibra Ocular Protection Index 2.0

    22. Schirmer's Test [End of Visit 2 (Day 1 of study)]

      Schirmer's Test

    Other Outcome Measures

    1. Adverse Event Query [Beginning of Visit 1 (Day 0)]

      All adverse events that are reported during these visits will be followed up on until they are resolved or stabilized

    2. Adverse Event Query [End of Visit 2 (Day 1)]

      All adverse events that are reported during these visits will be followed up on until they are resolved or stabilized

    3. Best Corrected Visual Acuity [Beginning and end of Visit 1 (Day 0)]

      Best Corrected Visual Acuity

    4. Best Corrected Visual Acuity [Beginning of Visit 2 (Day 1)]

      Best Corrected Visual Acuity

    5. Urine Pregnancy test [Beginning of Visit 1 (Day 0)]

      Urine Pregnancy test

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Andover Eye Associates Andover Massachusetts United States 01810

    Sponsors and Collaborators

    • ORA, Inc.

    Investigators

    • Principal Investigator: Gail Torkildsen, MD,

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    ORA, Inc.
    ClinicalTrials.gov Identifier:
    NCT05911555
    Other Study ID Numbers:
    • 13-270-0004
    First Posted:
    Jun 22, 2023
    Last Update Posted:
    Jun 22, 2023
    Last Verified:
    Jun 1, 2023
    Additional relevant MeSH terms:
    Dry Eye Syndromes
    Keratoconjunctivitis Sicca

    Study Results

    No Results Posted as of Jun 22, 2023