Trial Outcomes & Findings for Non-invasive Ocular Surface Measurements Before and After Interventions (NCT NCT01228929)
NCT ID: NCT01228929
Last Updated: 2015-10-12
Results Overview
Objectively evaluate the ocular surface temperature prior to and after 30 minutes of acclimation to three different environmental conditions in a controlled-environmental chamber using thermal imaging. 10 eyes were analyzed for each group.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
18 participants
Primary outcome timeframe
baseline and 30 minutes
Results posted on
2015-10-12
Participant Flow
Participant milestones
| Measure |
Normal
Subjects with no clinical diagnosis or symptoms of dry eye. Each participant completed 3 environmental conditions. Nominal is 75 degrees F and 40% relative humidity. Low humidity is 20% relative humidity and 75 degrees F. High temperature is 85 degrees F and 40% relative humidity.
|
Aqueous Deficiency Dry Eye (ADDE)
Subjects with low tear volume measured by Schirmer's test less than 10 mm. Each participant completed 3 environmental conditions. Nominal is 75 degrees F and 40% relative humidity. Low humidity is 20% relative humidity and 75 degrees F. High temperature is 85 degrees F and 40% relative humidity.
|
Meibomian Gland Dysfunction (MGD)
Subjects having mild to moderate Meibomian Gland Dysfunction by slit lamp evaluation. Each participant completed 3 environmental conditions. Nominal is 75 degrees F and 40% relative humidity. Low humidity is 20% relative humidity and 75 degrees F. High temperature is 85 degrees F and 40% relative humidity.
|
|---|---|---|---|
|
Nominal Condition
STARTED
|
6
|
6
|
6
|
|
Nominal Condition
COMPLETED
|
6
|
6
|
6
|
|
Nominal Condition
NOT COMPLETED
|
0
|
0
|
0
|
|
Low Humidity Condition
STARTED
|
6
|
6
|
6
|
|
Low Humidity Condition
COMPLETED
|
6
|
6
|
6
|
|
Low Humidity Condition
NOT COMPLETED
|
0
|
0
|
0
|
|
High Temperature Condition
STARTED
|
6
|
6
|
6
|
|
High Temperature Condition
COMPLETED
|
6
|
6
|
6
|
|
High Temperature Condition
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Non-invasive Ocular Surface Measurements Before and After Interventions
Baseline characteristics by cohort
| Measure |
Normal
n=6 Participants
Subjects with no clinical diagnosis or symptoms of dry eye.
|
Aqueous Deficiency Dry Eye (ADDE)
n=6 Participants
Subjects with low tear volume measured by Schirmer's test less than 10 mm.
|
Meibomian Gland Dysfunction (MGD)
n=6 Participants
Subjects having mild to moderate Meibomian Gland Dysfunction by slit lamp evaluation.
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
6 participants
n=5 Participants
|
18 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: baseline and 30 minutesObjectively evaluate the ocular surface temperature prior to and after 30 minutes of acclimation to three different environmental conditions in a controlled-environmental chamber using thermal imaging. 10 eyes were analyzed for each group.
Outcome measures
| Measure |
Normal
n=10 eyes
Subjects with no clinical diagnosis or symptoms of dry eye.
|
Aqueous Deficiency Dry Eye (ADDE)
n=10 eyes
Subjects with low tear volume measured by Schirmer's test less than 10 mm.
|
Meibomian Gland Dysfunction (MGD)
n=10 eyes
Subjects having mild to moderate Meibomian Gland Dysfunction by slit lamp evaluation.
|
|---|---|---|---|
|
Change in Ocular Surface Temperature (OST)
Nominal
|
0.047 degree celsius
Standard Deviation 0.03
|
0.020 degree celsius
Standard Deviation 0.03
|
0.127 degree celsius
Standard Deviation 0.04
|
|
Change in Ocular Surface Temperature (OST)
Low humidity
|
0.015 degree celsius
Standard Deviation 0.02
|
0.062 degree celsius
Standard Deviation 0.02
|
0.013 degree celsius
Standard Deviation 0.03
|
|
Change in Ocular Surface Temperature (OST)
High temperature
|
-0.060 degree celsius
Standard Deviation 0.02
|
0.064 degree celsius
Standard Deviation 0.02
|
-0.011 degree celsius
Standard Deviation 0.02
|
Adverse Events
Normal
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Aqueous Deficiency Dry Eye (ADDE)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Meibomian Gland Dysfunction (MGD)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place