Evaluation of Extended Tear Film Break Up Time (TFBUT) With an Ocular Emulsion
NCT ID: NCT01368198
Last Updated: 2012-02-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
50 participants
INTERVENTIONAL
2011-03-31
2011-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
DOUBLE
Study Groups
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Ocular Emulsion
An Ocular Emulsion
Systane Balance Lubricating Eye Drops
One instillation of the eye drop in each eye
OPTIVE™
An OPTIVE™
OPTIVE™
One instillation of the eye drop in each eye
Interventions
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Systane Balance Lubricating Eye Drops
One instillation of the eye drop in each eye
OPTIVE™
One instillation of the eye drop in each eye
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
Yes
Sponsors
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Optometric Technology Group Ltd
OTHER
Alcon Research
INDUSTRY
Responsible Party
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Locations
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Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, United States
OTG Research & Consultancy
London, England, United Kingdom
Countries
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Other Identifiers
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ID11-10
Identifier Type: -
Identifier Source: org_study_id
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