NCT01228929

Non-invasive Ocular Surface Measurements Before and After Interventions

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: University of Rochester · Academic / Other
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Accepted

Summary

Objectively evaluate the ocular surface (pre-corneal tear film) of individuals prior to and after an intervention (such as a dry eye treatment, environmental change, artificial tear use, or contact lens wear) in a controlled-environmental chamber, over time using non-contact instruments.

Detailed description

Most studies will set the environmental conditions (temperature, humidity, airflow) to mimic typical office and home environments (68 to 72F and 20 to 50%). For condition change studies, the chamber will operate between 65 and 85F and 25% and 80% RH with air flow turned off or set to a maximum of 3-4 m/s. For this type of study we will have the subject acclimate to a set of environmental conditions (approximately 20 minutes) and take a set of measurements. Then we will change the conditions (rate of change is 3F/hour and 3% RH/hour), have the subject acclimate to these conditions (later on the same day or on another day) and take another set of measurements. The expected study length is approximately two hours for a single visit.

Conditions

• Dry Eye Syndrome
• Healthy

Interventions

Type	Name	Description
OTHER	Environmental Chamber Condition Change Intervention	For condition change studies, the chamber will operate between 65 and 85 degrees F and 25% and 80% RH with air flow turned off or set to a maximum of 3-4 m/s. For this type of study, we will have the subject acclimate to a set of environmental conditions (approximately 20-30 minutes) and take a set of measurements. Then we will change the conditions (rate of change is 3 degrees F/hour and 3% RH/hour), have the subject acclimate to these conditions (later on the same day or on another day) and take another set of measurements. The expected study length is approximately two hours for a single visit. Subjects may be asked to return for additional visits to accommodate a variety of chamber conditions (temp, humidity, airflow) within the prescribed limits above.

Timeline

• Start date: 2010-07-01
• Primary completion: 2014-01-01
• Completion: 2014-01-01
• First posted: 2010-10-27
• Last updated: 2015-10-12
• Results posted: 2015-10-12

Locations

1 site across 1 country: United States