Trial Outcomes & Findings for Controlled Adverse Environment: A Pilot Study to Evaluate Tear Film Stability and Tear Evaporation (NCT NCT01448356)

Results Overview

The rate of tear evaporation is measured by the use of ocular thermography. For each subject,his/her ocular surface temperature will be recorded twice, one for each eye. The subject at first rests his/her chin on a chin rest, with his/her forehead lean against a metal frame (which is part of the chin rest). Then the recording starts lasting approximately 20seconds for each eye. While recording, the subject needs to look straight into the lens, but can blink naturally. After this, the recording data will be analyzed to derive the evaporation rate using a mathematical model.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

10 participants

Primary outcome timeframe

20 minutes after the required temperature and humidity in the chamber is achieved

Results posted on

2012-12-12

Participant Flow

Participant milestones

Participant milestones
Measure	Temperature and Humidity All conditions were tested in a CAE chamber on the same day.
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Controlled Adverse Environment: A Pilot Study to Evaluate Tear Film Stability and Tear Evaporation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Temperature and Humidity n=10 Participants All conditions were tested in a CAE chamber on the same day.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	20.4 years STANDARD_DEVIATION 1.3 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Region of Enrollment Singapore	10 participants n=5 Participants

PRIMARY outcome

Timeframe: 20 minutes after the required temperature and humidity in the chamber is achieved

The rate of tear evaporation is measured by the use of ocular thermography. For each subject,his/her ocular surface temperature will be recorded twice, one for each eye. The subject at first rests his/her chin on a chin rest, with his/her forehead lean against a metal frame (which is part of the chin rest). Then the recording starts lasting approximately 20seconds for each eye. While recording, the subject needs to look straight into the lens, but can blink naturally. After this, the recording data will be analyzed to derive the evaporation rate using a mathematical model.

Outcome measures

Outcome measures
Measure	Temperature and Humidity n=10 Participants Tear evaporation of overall surface
Tear Evaporation Rate 30°C and 65% humidity	26.7 Watt/meter^2 Interval 21.3 to 32.0
Tear Evaporation Rate 25°C and 45% humidity	39.0 Watt/meter^2 Interval 33.0 to 45.0
Tear Evaporation Rate 25°C and 65% humidity	44.8 Watt/meter^2 Interval 39.4 to 50.3
Tear Evaporation Rate 30°C and 45% humidity	30.6 Watt/meter^2 Interval 25.9 to 35.4

SECONDARY outcome

Timeframe: 20 minutes after the required temperature and humidity in the chamber is achieved

After instillation of fluorescein, the participant will then be asked to open the eyes, look ahead at the observer's forehead and not blink for as long as possible. The break up time is defined as the time between the lid opening and the first appearance of any dry spot on the cornea. The participant will be requested to close his eyes for few seconds and the procedure will be repeated for the left eye.

Outcome measures

Outcome measures
Measure	Temperature and Humidity n=10 Participants Tear evaporation of overall surface
Tear Film Break up Time 30°C and 65% humidity	4.6 seconds Interval 3.0 to 6.2
Tear Film Break up Time 25°C and 45% humidity	5.9 seconds Interval 4.0 to 7.7
Tear Film Break up Time 25°C and 65% humidity	4.4 seconds Interval 3.1 to 5.7
Tear Film Break up Time 30°C and 45% humidity	5.0 seconds Interval 3.2 to 6.9

Adverse Events

Temperature and Humidity

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

Dr Andrea Petznick

Singapore Eye Research Institute

Phone: +65 6322

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place