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

Completed · Not applicable

Conditions studied: Dry Eye

In brief

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.

Key facts

Study ID

NCT01368198

Run by

Alcon Research

People needed

50

Starts

2011-03-01

Expected to finish

2011-06-01

Last updated by the study team

2012-02-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Contact Alcon Call Center for Trial Locations — Fort Worth, Texas, United States
• OTG Research & Consultancy — London, England, United Kingdom

Full record on ClinicalTrials.gov

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