An observational study in Dry Eye, sponsored by ORA, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-22.
Sponsored by ORA, Inc. · Observational
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.
1,292 studies on the registry are indexed under Dry Eye Syndromes; 191 are open to participants now.
This study's enrollment of 34 is below the median of 90 across 171 observational studies indexed under Dry Eye Syndromes.
Browse Dry Eye Syndromes studies →ORA, Inc. is the lead sponsor of 25 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Subjects with dry eye will be selected from a previous trial and subjects without dry eye will be also be enrolled.
Exclusion Criteria:
Subjects with no reported history of dry eye disease will be enrolled
Subjects who have been diagnosed with dry eye disease in a previous trial will be enrolled.
Mucin levels assayed from collected tears
Tears will be collected and mucin will be measured after subjects are exposed to the CAE.
Time frame: 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.
Time frame: 24 hours after being exposed to the CAE
Fluorescein staining
staining will be measured to detect presence of Superficial Punctate Keratitis and Confluency using Ora Calibra™ Corneal and Conjunctival Staining Scales
Time frame: pre-CAE
Fluorescein staining
Staining will be measured to detect presence of Superficial Punctate Keratitis and Confluency using Ora Calibra™ Corneal and Conjunctival Staining Scales
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 24 hours post-CAE
Presence of conjunctival redness
conjunctival redness will be assessed by Ora Calibra™ Conjunctival Redness Scale
Time frame: pre-CAE
Presence of conjunctival redness
conjunctival redness will be assessed by Ora Calibra™ Conjunctival Redness Scale
Time frame: 10-30 minutes Post CAE
Presence of conjunctival redness
conjunctival redness will be assessed by Ora Calibra™ Conjunctival Redness Scale
Time frame: 24 hours post-CAE
Tear Film Break Up Time
Tear Film Break Up Time
Time frame: pre-CAE
Tear Film Break Up Time
Tear Film Break Up Time
Time frame: 10-30 minutes Post CAE
Tear Film Break Up Time
Tear Film Break Up Time
Time frame: 24 hours post-CAE
Blink Rate Analysis
Blink Rate Analysis
Time frame: pre-CAE
Blink Rate Analysis
Blink Rate Analysis
Time frame: 10-30 minutes Post CAE
Blink Rate Analysis
Blink Rate Analysis
Time frame: 24 hours post-CAE
Symptom Collection
Symptom Collection
Time frame: pre-CAE
Symptom Collection
Symptom Collection
Time frame: 10-30 minutes Post CAE
Symptom Collection
Symptom Collection
Time frame: 24 hours post-CAE
Ora Calibra Ocular Protection Index 2.0
Ora Calibra Ocular Protection Index 2.0
Time frame: pre-CAE
Ora Calibra Ocular Protection Index 2.0
Ora Calibra Ocular Protection Index 2.0
Time frame: 10-30 minutes Post CAE
Ora Calibra Ocular Protection Index 2.0
Ora Calibra Ocular Protection Index 2.0
Time frame: 24 hours post-CAE
Schirmer's Test
Schirmer's Test
Time frame: End of Visit 2 (Day 1 of study)
Adverse Event Query
All adverse events that are reported during these visits will be followed up on until they are resolved or stabilized
Time frame: 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
Time frame: End of Visit 2 (Day 1)
Best Corrected Visual Acuity
Best Corrected Visual Acuity
Time frame: Beginning and end of Visit 1 (Day 0)
Best Corrected Visual Acuity
Best Corrected Visual Acuity
Time frame: Beginning of Visit 2 (Day 1)
Urine Pregnancy test
Urine Pregnancy test
Time frame: Beginning of Visit 1 (Day 0)
This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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ORA, Inc.