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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Fluorescein staining | staining will be measured to detect presence of Superficial Punctate Keratitis and Confluency using Ora Calibra™ Corneal and Conjunctival Staining Scales | pre-CAE |
| Fluorescein staining |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Event Query | All adverse events that are reported during these visits will be followed up on until they are resolved or stabilized | Beginning of Visit 1 (Day 0) |
| Adverse Event Query | All adverse events that are reported during these visits will be followed up on until they are resolved or stabilized |
Inclusion Criteria:
Exclusion Criteria:
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Subjects with dry eye will be selected from a previous trial and subjects without dry eye will be also be enrolled.
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| Name | Affiliation | Role |
|---|---|---|
| Gail Torkildsen, MD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Andover Eye Associates | Andover | Massachusetts | 01810 | United States |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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Tear collection
Staining will be measured to detect presence of Superficial Punctate Keratitis and Confluency using Ora Calibra™ Corneal and Conjunctival Staining Scales
| 10-30 minutes Post CAE |
| Fluorescein staining | Staining will be measured measured to detect presence of Superficial Punctate Keratitis and Confluency using Ora Calibra™ Corneal and Conjunctival Staining Scales | 24 hours post-CAE |
| Lissamine staining | Staining will be measured to detect presence of Superficial Punctate Keratitis and Confluency using Ora Calibra™ Corneal and Conjunctival Staining Scales | pre-CAE |
| Lissamine staining | Staining will be measured to detect presence of Superficial Punctate Keratitis and Confluency using Ora Calibra™ Corneal and Conjunctival Staining Scales | 10-30 minutes Post CAE |
| Lissamine staining | Staining will be measured to detect presence of Superficial Punctate Keratitis and Confluency using Ora Calibra™ Corneal and Conjunctival Staining Scales | 24 hours post-CAE |
| Presence of conjunctival redness | conjunctival redness will be assessed by Ora Calibra™ Conjunctival Redness Scale | pre-CAE |
| Presence of conjunctival redness | conjunctival redness will be assessed by Ora Calibra™ Conjunctival Redness Scale | 10-30 minutes Post CAE |
| Presence of conjunctival redness | conjunctival redness will be assessed by Ora Calibra™ Conjunctival Redness Scale | 24 hours post-CAE |
| Tear Film Break Up Time | Tear Film Break Up Time | pre-CAE |
| Tear Film Break Up Time | Tear Film Break Up Time | 10-30 minutes Post CAE |
| Tear Film Break Up Time | Tear Film Break Up Time | 24 hours post-CAE |
| Blink Rate Analysis | Blink Rate Analysis | pre-CAE |
| Blink Rate Analysis | Blink Rate Analysis | 10-30 minutes Post CAE |
| Blink Rate Analysis | Blink Rate Analysis | 24 hours post-CAE |
| Symptom Collection | Symptom Collection | pre-CAE |
| Symptom Collection | Symptom Collection | 10-30 minutes Post CAE |
| Symptom Collection | Symptom Collection | 24 hours post-CAE |
| Ora Calibra Ocular Protection Index 2.0 | Ora Calibra Ocular Protection Index 2.0 | pre-CAE |
| Ora Calibra Ocular Protection Index 2.0 | Ora Calibra Ocular Protection Index 2.0 | 10-30 minutes Post CAE |
| Ora Calibra Ocular Protection Index 2.0 | Ora Calibra Ocular Protection Index 2.0 | 24 hours post-CAE |
| Schirmer's Test | Schirmer's Test | End of Visit 2 (Day 1 of study) |
| End of Visit 2 (Day 1) |
| Best Corrected Visual Acuity | Best Corrected Visual Acuity | Beginning and end of Visit 1 (Day 0) |
| Best Corrected Visual Acuity | Best Corrected Visual Acuity | Beginning of Visit 2 (Day 1) |
| Urine Pregnancy test | Urine Pregnancy test | Beginning of Visit 1 (Day 0) |