Evaluation of Extended Tear Film Break Up Time (TFBUT) With an Ocular Emulsion

Sponsor

Alcon Research (Industry)

Overall Status

Completed

CT.gov ID

NCT01368198

Collaborator

Optometric Technology Group Ltd (Other)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

8.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective of this investigation will be to quantify the increase in tear film break-up time (TFBUT) associated with the instillation of a single eyedrop of an Ocular Emulsion in dry eye sufferers.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye	Other: Systane Balance Lubricating Eye Drops Other: OPTIVE™	N/A

Detailed Description

The secondary objective of this investigation will be to compare the tear film break up time measured with two different techniques.

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Basic Science

Official Title:

The Evaluation of Extended Tear Film Break Up Time (TFBUT) With an Ocular Emulsion

Study Start Date :

Mar 1, 2011

Actual Primary Completion Date :

Jun 1, 2011

Actual Study Completion Date :

Jun 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Ocular Emulsion An Ocular Emulsion	Other: Systane Balance Lubricating Eye Drops One instillation of the eye drop in each eye Other Names: Ocular Emulsion
Active Comparator: OPTIVE™ An OPTIVE™	Other: OPTIVE™ One instillation of the eye drop in each eye Other Names: Optive

Arm

Intervention/Treatment

Active Comparator: Ocular Emulsion

An Ocular Emulsion

Other: Systane Balance Lubricating Eye Drops

One instillation of the eye drop in each eye

Other Names:

Ocular Emulsion

Active Comparator: OPTIVE™

An OPTIVE™

Other: OPTIVE™

One instillation of the eye drop in each eye

Other Names:

Optive

Outcome Measures

Primary Outcome Measures

Measurement of the tear film break-up time using DET sodium fluorescein strips. [Enrollment Test visit 1]

Secondary Outcome Measures

Measurement of the tear film break-up time in a non invasive manner using the Tearscope®. Measurement of the tear film break-up time in a non invasive manner using the Tearscope®. [Enrollment Test visit 2]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

The subject must be 18 years of age or older;
The subject must have a best corrected visual acuity of 0.6 LogMAR (~6/24) or better in each eye
The subject must not have used any topical ocular drops for approximately 24 hours prior to the enrolment/screening visit
The subject must be classified as dry eye at enrolment/screening visit according to the following criteria:

Subjects' self-assessment of dry eye status (answer of at least "some of the time" to the question, "How often have your eyes felt dry enough to want to use eye drops?");
TFBUT measured with DET ≤ 5 seconds in at least one eye;
Grade 1 for meibomian gland expression in both eyes;
Evidence of missing meibomian glands in both eyes.

Exclusion Criteria:

History or evidence of ocular or intraocular surgery in either eye within the past six months.
History or evidence of serious ocular trauma in either eye within the past six months.
Current punctal occlusion of any type (e.g., collagen plugs, silicone plugs).
History or evidence of epithelial herpes simplex keratitis (dendritic keratitis); vaccinia; active or recent varicella viral disease of the cornea and/or conjunctiva; chronic bacterial disease of the cornea and/or conjunctiva and/or eyelids; mycobacterial infection of the eye; and/or fungal disease of the eye.
Use of any concomitant topical ocular medications during the study period.
Ocular conditions such as conjunctival infections, iritis, or any other ocular condition that may preclude the safe administration of either drop under investigation.
Participation in an investigational drug or device study within 30 days of entering this study.