Effect of Controlled Adverse Environment (CAE) on Tear Film Stability

Keratoconjunctivitis Sicca Clinical Trial

Official title:

A Single-Center Study Evaluating the Effect of the Controlled Adverse Environment (CAE) on Tear Film Stability Using the OPI 2.0 System, Ocular Protection Index (OPI), Tear Film Break-Up Time (TFBUT) and Mean Break up Area by Region (MBA) in Patients Diagnosed With Dry Eye Evaluated During Their Natural Blink Pattern

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01547936
• Other study ID #: 12-270-0002
• Status: Completed
• Phase: N/A
• First received: February 15, 2012
• Last updated: March 5, 2012
• Start date: February 2012
• Est. completion date: February 2012

Study information

• Verified date: March 2012
• Source: ORA, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to evaluate the effect of the controlled adverse environment (CAE) on Mean Break-Up Area in subjects diagnosed with Dry Eye Syndrome.

Description:

Single-Center, Pilot, controlled adverse environment (CAE) Study.

This is a single-center, one visit, pilot, CAE study. Dry Eye Subjects (N=30) who qualify will undergo tear film video recording, fluorescein staining, and break up time before CAE exposure and after CAE exposure.

All subjects will undergo baseline dry eye assessments including fluorescein staining, breakup time, conjunctival redness and tear film video recording. Subjects who qualify will then undergo CAE exposure for 90 minutes. At the end of CAE exposure subjects will undergo dry eye assessments again.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• At least 18 years of age & either sex, any race

• Willing and able to follow all instructions

• Positive history of dry eye disease

• Use or desire to use drops for dry eye within the past 6 months

Exclusion Criteria:

• Have planned surgery during trial period

• Female currently pregnant, planning a pregnancy or lactating

• Use of disallowed medications

• Have ocular infections, or ocular conditions that could affect study parameters

• Have used an investigational drug or device within 30 days of start of study

• Female that is currently pregnant, planning a pregnancy or lactating

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Keratoconjunctivitis
• Keratoconjunctivitis Sicca

Locations

Country	Name	City	State
United States	Andover Eye Associates	Andover	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
ORA, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in tear film break up area		change from baseline in tear film break up area at 30 minutes post-CAE at study visit	No
Secondary	change in Fluorescein Staining		change from baseline in staining at 30 minutes post-CAE	No
Secondary	Change in Tear film break up time (TFBUT)		change from baseline in tear film break up time at 30 minutes post-CAE	No
Secondary	Change in Conjunctival Redness		change from baseline in conjunctival redness at 30 minutes post-CAE	No