Clinical trial NCT01448356: Controlled Adverse Environment: A Pilot Study to Evaluate Tear Film Stability and Tear Evaporation
Official title: Controlled Adverse Environment: A Pilot Study to Evaluate Tear Film Stability and Tear Evaporation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Environmental Exposure
Keywords: Controlled adverse chamber
tear film stability
tear film evaporation
tear film break up time
humidity
temperature
Lead sponsor: Singapore Eye Research Institute
Sponsor class: OTHER
Collaborators: name: Singapore National Eye Centre
First posted: 2011-10-07
Enrollment: 10
Sex: ALL
Minimum age (years): 21
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

Detailed description: Study Objectives and Purpose:

1. A primary purpose of the study is to evaluate fluorescein tear break up times in participants under different humidity/ temperature conditions.
2. The second aim is to assess the tear evaporation rates in a dynamic fashion over 20 seconds (based on a non-invasive ocular thermography method) after exposure to different humidity/temperature conditions.

Study Design: Prospective, non-comparative, clinical study

Rationale:

The ocular surface research team who is based at the dry eye service of the Singapore National Eye Center is experienced in the assessment of the ocular surface in patients and clinical trial participants. Collaborators from the DSO National laboratory already have experience in conducting human studies in a controlled environment in Singapore that has been proven to be safe and has passed necessary regulatory approval. In addition, recent technological advances have allowed collaborators from NTU and Singapore Polytechnic to perform non-invasive tear evaporimetry in a dynamic way between blinks. Together, this is a strong research team that can address the important question of the influence of temperature and humidity on the tear film stability.

Methods:

We intend to use 10 volunteer/patients to establish whether tear film stability or tear film function can be altered after exposure to different combinations of humidity and temperature. This involves the assessment of tear film break up time (TBUT) and tear evaporimetry, a non-invasive procedure (like an auto-refractor where the patient places the chin on the chin rest and forehead on the head rest when the measurement is taken) which involves taking serial images with an infra red sensitive video camera. This process is performed at a facility which is closely monitored and proven to be safe for other research participants.

Participants and target sample size: Ten participants will be recruited.

Workflow:

We assume that approximately 45 minutes are required for the chamber to achieve the required temperature and humidity, and about 15 to 20 minutes for participants to adjust to the first environmental setting. Thermography measurement will take 1 minute (20 sec in each eye, with adjustment of camera between eyes). The participants will undergo slit lamp examination where the fluorescein tear break up time will be assessed and digital color image of the break up pattern will be taken. These will require a further 5 minutes. This means 3 participants can have measurements done in approximately 20 minutes. Measurements of 3 participants in a single condition will therefore take up to 20 minutes.In a session that will last up to 3 hours and 20 minutes, the investigators can complete the condition list for 3 participants. Since the overall session is quite long, a toilet break is permitted after each temperature condition.

The investigators estimate that 3 sessions with a further 'dry run' for the photography (without participants) before the first session will be necessary.

Visit schedules:

Volunteers or patients from the Singapore National Eye Center will be informed of this study. Screening will be performed at the regular dry eye clinic at the Singapore National Eye Center. If eligible, the volunteer or patient will sign consent and undergo baseline examination. Subsequent to this, the examination will be performed at the controlled adverse environment at the DSO facility.

Assessment of ocular parameters is outlined below:

At Screening visit, the investigators perform:

* Informed consent
* Subject background
* Anterior segment findings
* Tear film break up time

At Evaluation visit, the investigators perform:

* Tear film break up time
* Photography/Video to document tear break up
* Tear evaporimetry

Duration of study: Four weeks.

Eligibility criteria: Inclusion Criteria:

* must have undergone screening examination

Exclusion Criteria:

* unable to go to the DSO laboratory or undergo any of the study procedures

Primary outcomes:
measure: Tear Evaporation Rate
timeFrame: 20 minutes after the required temperature and humidity in the chamber is achieved
Secondary outcomes:
measure: Tear Film Break up Time
timeFrame: 20 minutes after the required temperature and humidity in the chamber is achieved
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Singapore Eye Research Institute
Study officials:
affiliation: Singapore Eye Research Institute
name: Andrea Petznick, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Wolkoff 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.