Dry Eye
Conditions
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.
Interventions
None listed
Sponsors
ORA, Inc.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tear Film Break Up Time | pre-CAE | Tear Film Break Up Time |
| Symptom Collection | pre-CAE | Symptom Collection |
| Ora Calibra Ocular Protection Index 2.0 | pre-CAE | Ora Calibra Ocular Protection Index 2.0 |
| Schirmer's Test | End of Visit 2 (Day 1 of study) | Schirmer's Test |
| 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 |
| 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 |
| Presence of conjunctival redness | pre-CAE | conjunctival redness will be assessed by Ora Calibra™ Conjunctival Redness Scale |
| Blink Rate Analysis | pre-CAE | Blink Rate Analysis |
Other
| Measure | Time frame | Description |
|---|---|---|
| Urine Pregnancy test | Beginning of Visit 1 (Day 0) | Urine Pregnancy test |
| Best Corrected Visual Acuity | Beginning and end of Visit 1 (Day 0) | Best Corrected Visual Acuity |
| 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 |
Countries
United States
Outcome results
None listed