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Completed

NCT Number: NCT05911555

Mucin Levels in Dry Eye and Normal Populations

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Andover Eye Associates

Andover, Massachusetts, 01810, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Mucin levels assayed from collected tears

    Time frame: 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

    Time frame: 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 outcomes

  1. Fluorescein staining

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: pre-CAE

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

  8. Presence of conjunctival redness

    Time frame: 10-30 minutes Post CAE

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

  9. Presence of conjunctival redness

    Time frame: 24 hours post-CAE

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

  10. Tear Film Break Up Time

    Time frame: pre-CAE

    Tear Film Break Up Time

  11. Tear Film Break Up Time

    Time frame: 10-30 minutes Post CAE

    Tear Film Break Up Time

  12. Tear Film Break Up Time

    Time frame: 24 hours post-CAE

    Tear Film Break Up Time

  13. Blink Rate Analysis

    Time frame: pre-CAE

    Blink Rate Analysis

  14. Blink Rate Analysis

    Time frame: 10-30 minutes Post CAE

    Blink Rate Analysis

  15. Blink Rate Analysis

    Time frame: 24 hours post-CAE

    Blink Rate Analysis

  16. Symptom Collection

    Time frame: pre-CAE

    Symptom Collection

  17. Symptom Collection

    Time frame: 10-30 minutes Post CAE

    Symptom Collection

  18. Symptom Collection

    Time frame: 24 hours post-CAE

    Symptom Collection

  19. Ora Calibra Ocular Protection Index 2.0

    Time frame: pre-CAE

    Ora Calibra Ocular Protection Index 2.0

  20. Ora Calibra Ocular Protection Index 2.0

    Time frame: 10-30 minutes Post CAE

    Ora Calibra Ocular Protection Index 2.0

  21. Ora Calibra Ocular Protection Index 2.0

    Time frame: 24 hours post-CAE

    Ora Calibra Ocular Protection Index 2.0

  22. Schirmer's Test

    Time frame: End of Visit 2 (Day 1 of study)

    Schirmer's Test

Other outcomes

  1. Adverse Event Query

    Time frame: 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

    Time frame: 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

    Time frame: Beginning and end of Visit 1 (Day 0)

    Best Corrected Visual Acuity

  4. Best Corrected Visual Acuity

    Time frame: Beginning of Visit 2 (Day 1)

    Best Corrected Visual Acuity

  5. Urine Pregnancy test

    Time frame: Beginning of Visit 1 (Day 0)

    Urine Pregnancy test

Sponsors and collaborators

Lead sponsor

ORA, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jun 22, 2023
Registry last updated
Jun 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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