Andover Eye Associates
Andover, Massachusetts, 01810, United States
NCT Number: NCT05911555
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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Notify Me18 year and older
All sexes
Observational
Andover, Massachusetts, 01810, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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
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
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
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
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
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
Time frame: pre-CAE
conjunctival redness will be assessed by Ora Calibra™ Conjunctival Redness Scale
Time frame: 10-30 minutes Post CAE
conjunctival redness will be assessed by Ora Calibra™ Conjunctival Redness Scale
Time frame: 24 hours post-CAE
conjunctival redness will be assessed by Ora Calibra™ Conjunctival Redness Scale
Time frame: pre-CAE
Tear Film Break Up Time
Time frame: 10-30 minutes Post CAE
Tear Film Break Up Time
Time frame: 24 hours post-CAE
Tear Film Break Up Time
Time frame: pre-CAE
Blink Rate Analysis
Time frame: 10-30 minutes Post CAE
Blink Rate Analysis
Time frame: 24 hours post-CAE
Blink Rate Analysis
Time frame: pre-CAE
Symptom Collection
Time frame: 10-30 minutes Post CAE
Symptom Collection
Time frame: 24 hours post-CAE
Symptom Collection
Time frame: pre-CAE
Ora Calibra Ocular Protection Index 2.0
Time frame: 10-30 minutes Post CAE
Ora Calibra Ocular Protection Index 2.0
Time frame: 24 hours post-CAE
Ora Calibra Ocular Protection Index 2.0
Time frame: End of Visit 2 (Day 1 of study)
Schirmer's Test
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
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
Time frame: Beginning and end of Visit 1 (Day 0)
Best Corrected Visual Acuity
Time frame: Beginning of Visit 2 (Day 1)
Best Corrected Visual Acuity
Time frame: Beginning of Visit 1 (Day 0)
Urine Pregnancy test
ORA, Inc.
Industry
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
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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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