This study is an exploratory trial evaluating the tear film break-up time after a single eye
drop instillation of over-the-counter artificial tears. The primary hypothesis is that tear
film break up time will be greater for test than control eye.
Subjects with varying degrees of dry eye syndrome were enrolled in a randomized, controlled,
double masked, single site study. A new formulation of an artificial tear containing
glycerin 1% as an active with polylysine-graft-polyethylene glycol as an excipient was
compared against a leading commercial product with propylene glycol (0.3%) and polyethylene
glycol (0.4%) as active ingredients with hydroxypropyl-guar as a gelling agent. The primary
outcome was a comparison of tear film stability after eye drop instillation.
- Age > 18 years
- symptoms of dry eye
- no other history of ophthalmic problems
- Use of any ocular lubricant or ointment in the past 36 hours
- use of contact lenses or excessive eye lid cosmetics on the study day