Controlled Adverse Environment: A Pilot Study to Evaluate Tear Film Stability and Tear Evaporation
2 other identifiers
interventional
10
1 country
1
Brief Summary
Dry eye and ocular surface disease account for a lot of morbidity and socio-economic burden in Asia and the rest of the world. This is a small pilot study to evaluate tear function under different conditions of humidity and temperature. This data will be useful for designing future trials in ocular surface and dry eye. The data will likely be used to propose a larger national funded project involving clinical trials. This study involves collaboration between engineers, ocular surface clinicians as well as specialists from the defence science organisation. When successfully completed, the project will increase the capability of Singapore Eye Research Institute and Singapore National Eye Centre to support future industry and academic research in the ocular surface.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2012
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 4, 2011
CompletedFirst Posted
Study publicly available on registry
October 7, 2011
CompletedStudy Start
First participant enrolled
January 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedResults Posted
Study results publicly available
December 12, 2012
CompletedDecember 12, 2012
November 1, 2012
3 months
October 4, 2011
July 17, 2012
November 14, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Tear Evaporation Rate
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.
20 minutes after the required temperature and humidity in the chamber is achieved
Secondary Outcomes (1)
Tear Film Break up Time
20 minutes after the required temperature and humidity in the chamber is achieved
Study Arms (1)
temperature and humidity
EXPERIMENTALThe volunteer is exposed to a controlled environment with a chamber setting of: 1. 25°C and 45% humidity; 2. 25°C and 65% humidity; 3. 30°C and 45% humidity; 4. 30°C and 65% humidity
Interventions
The volunteer is exposed to a controlled environment with a chamber setting of: 1. 25°C and 45% humidity; 2. 25°C and 65% humidity; 3. 30°C and 45% humidity; 4. 30°C and 65% humidity After an adaptation period of at least 20 minutes, participants underwent measurements of tear evaporation and tear film break up time. After collection of data, the chamber settings were adjusted to the next condition.
Eligibility Criteria
You may qualify if:
- must have undergone screening examination
You may not qualify if:
- unable to go to the DSO laboratory or undergo any of the study procedures
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Singapore Eye Research Institutelead
- Singapore National Eye Centrecollaborator
Study Sites (1)
Singapore Eye Research Institute
Singapore, Singapore, 168751, Singapore
Related Publications (2)
Gonzalez-Garcia MJ, Gonzalez-Saiz A, de la Fuente B, Morilla-Grasa A, Mayo-Iscar A, San-Jose J, Feijo J, Stern ME, Calonge M. Exposure to a controlled adverse environment impairs the ocular surface of subjects with minimally symptomatic dry eye. Invest Ophthalmol Vis Sci. 2007 Sep;48(9):4026-32. doi: 10.1167/iovs.06-0817.
PMID: 17724183BACKGROUNDWolkoff P. Ocular discomfort by environmental and personal risk factors altering the precorneal tear film. Toxicol Lett. 2010 Dec 15;199(3):203-12. doi: 10.1016/j.toxlet.2010.09.001. Epub 2010 Sep 15.
PMID: 20833234BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr Andrea Petznick
- Organization
- Singapore Eye Research Institute
Study Officials
- PRINCIPAL INVESTIGATOR
Andrea Petznick, PhD
Singapore Eye Research Institute
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Postdoctoral Research Fellow
Study Record Dates
First Submitted
October 4, 2011
First Posted
October 7, 2011
Study Start
January 1, 2012
Primary Completion
April 1, 2012
Study Completion
April 1, 2012
Last Updated
December 12, 2012
Results First Posted
December 12, 2012
Record last verified: 2012-11