Clinical trial NCT05911555: Mucin Levels in Dry Eye and Normal Populations
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dry Eye
Lead sponsor: ORA, Inc.
Sponsor class: INDUSTRY
First posted: 2023-06-22
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mucin levels assayed from collected tears
timeFrame: 10-30 minutes Post CAE at Visit 1
measure: Mucin levels assayed from collected tears
timeFrame: 24 hours after being exposed to the CAE
Secondary outcomes:
measure: Fluorescein staining
timeFrame: pre-CAE
measure: Fluorescein staining
timeFrame: 10-30 minutes Post CAE
measure: Fluorescein staining
timeFrame: 24 hours post-CAE
measure: Lissamine staining
timeFrame: pre-CAE
measure: Lissamine staining
timeFrame: 10-30 minutes Post CAE
measure: Lissamine staining
timeFrame: 24 hours post-CAE
measure: Presence of conjunctival redness
timeFrame: pre-CAE
measure: Presence of conjunctival redness
timeFrame: 10-30 minutes Post CAE
measure: Presence of conjunctival redness
timeFrame: 24 hours post-CAE
measure: Tear Film Break Up Time
timeFrame: pre-CAE
measure: Tear Film Break Up Time
timeFrame: 10-30 minutes Post CAE
measure: Tear Film Break Up Time
timeFrame: 24 hours post-CAE
measure: Blink Rate Analysis
timeFrame: pre-CAE
measure: Blink Rate Analysis
timeFrame: 10-30 minutes Post CAE
measure: Blink Rate Analysis
timeFrame: 24 hours post-CAE
measure: Symptom Collection
timeFrame: pre-CAE
measure: Symptom Collection
timeFrame: 10-30 minutes Post CAE
measure: Symptom Collection
timeFrame: 24 hours post-CAE
measure: Ora Calibra Ocular Protection Index 2.0
timeFrame: pre-CAE
measure: Ora Calibra Ocular Protection Index 2.0
timeFrame: 10-30 minutes Post CAE
measure: Ora Calibra Ocular Protection Index 2.0
timeFrame: 24 hours post-CAE
measure: Schirmer's Test
timeFrame: End of Visit 2 (Day 1 of study)
Other outcomes:
measure: Adverse Event Query
timeFrame: Beginning of Visit 1 (Day 0)
measure: Adverse Event Query
timeFrame: End of Visit 2 (Day 1)
measure: Best Corrected Visual Acuity
timeFrame: Beginning and end of Visit 1 (Day 0)
measure: Best Corrected Visual Acuity
timeFrame: Beginning of Visit 2 (Day 1)
measure: Urine Pregnancy test
timeFrame: Beginning of Visit 1 (Day 0)
Locations:
city: Andover
country: United States
facility: Andover Eye Associates
state: Massachusetts
Study officials:
name: Gail Torkildsen, MD
role: PRINCIPAL_INVESTIGATOR
References: