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

Alcon

Status

Completed

Conditions

Dry Eye

Treatments

Other: OPTIVE™

Other: Systane Balance Lubricating Eye Drops

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01368198

ID11-10

Details and patient eligibility

About

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.

Full description

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

Enrollment

50 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.