Clinical trial NCT01368198: Evaluation of Extended Tear Film Break Up Time (TFBUT) With an Ocular Emulsion
Official title: The Evaluation of Extended Tear Film Break Up Time (TFBUT) With an Ocular Emulsion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye
Keywords: Ocular Emulsion
OPTIVE™ Lubricant
Tear Film Break Up Time
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
Collaborators: name: Optometric Technology Group Ltd
First posted: 2011-06-07
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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

Eligibility criteria: Inclusion Criteria:

1. The subject must be 18 years of age or older;
2. The subject must have a best corrected visual acuity of 0.6 LogMAR (\~6/24) or better in each eye
3. The subject must not have used any topical ocular drops for approximately 24 hours prior to the enrolment/screening visit
4. 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:

1. History or evidence of ocular or intraocular surgery in either eye within the past six months.
2. History or evidence of serious ocular trauma in either eye within the past six months.
3. Current punctal occlusion of any type (e.g., collagen plugs, silicone plugs).
4. 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.
5. Use of any concomitant topical ocular medications during the study period.
6. Ocular conditions such as conjunctival infections, iritis, or any other ocular condition that may preclude the safe administration of either drop under investigation.
7. Participation in an investigational drug or device study within 30 days of entering this study.

Primary outcomes:
measure: Measurement of the tear film break-up time using DET sodium fluorescein strips.
timeFrame: Enrollment Test visit 1
Secondary outcomes:
measure: 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®.
timeFrame: Enrollment Test visit 2
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Contact Alcon Call Center for Trial Locations
state: Texas
city: London
country: United Kingdom
facility: OTG Research & Consultancy
state: England
Study officials:
References: