Title
Tear Film Break-up Time After Instillation of Artificial Tears
A Randomized, Masked Exploratory Trial Comparing the Effect of Two Different Over-the-Counter Artificial Tear Preparations on Tear Film Break-up Time
Phase
N/ALead Sponsor
Eyeon Therapeutics, Inc.Study Type
InterventionalStatus
Completed Results PostedIndication/Condition
Keratoconjunctivitis SiccaIntervention/Treatment
glycerin polyethylene glycol ...Study Participants
16This 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.
Eye drop with active agent glycerin 1%, new topical ophthalmic formulation with polylysine-graft-polyethylene glycol as an excipient, single instillation.
Eye drop with the active agents polyethylene glycol 400 0.4% /propylene glycol 0.3%, topical ophthalmic formulation, single instillation
One eye will randomly receive a single instillation of one drop of a new formulation of an artificial tear containing glycerin 1% as an active with polylysine-graft-polyethylene glycol as an excipient.
The other eye will receive a single instillation of one drop of an artificial tear with propylene glycol (0.3%) and polyethylene glycol (0.4%) as active ingredients with hydroxypropyl-guar as a gelling agent.
Inclusion Criteria: Age > 18 years symptoms of dry eye no other history of ophthalmic problems Exclusion Criteria: 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
| Event Type | Organ System | Event Term |
|---|
State-of-the-art methodology to assess tear stability.
Standard clinical assessment methodology for assessing tear stability.
