Tear Film Break-up Time After Instillation of Artificial Tears
|ClinicalTrials.gov Identifier: NCT00681265|
Recruitment Status : Completed
First Posted : May 21, 2008
Results First Posted : October 26, 2012
Last Update Posted : October 26, 2012
|Condition or disease||Intervention/treatment||Phase|
|Keratoconjunctivitis Sicca||Drug: glycerin Drug: polyethylene glycol 400/propylene glycol||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Randomized, Masked Exploratory Trial Comparing the Effect of Two Different Over-the-Counter Artificial Tear Preparations on Tear Film Break-up Time|
|Study Start Date :||June 2008|
|Actual Primary Completion Date :||August 2008|
|Actual Study Completion Date :||August 2008|
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.
Eye drop with active agent glycerin 1%, new topical ophthalmic formulation with polylysine-graft-polyethylene glycol as an excipient, single instillation.
Other Name: Eyeon Protect(TM)
Active Comparator: polyethylene glycol 400/propylene glycol
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.
Drug: polyethylene glycol 400/propylene glycol
Eye drop with the active agents polyethylene glycol 400 0.4% /propylene glycol 0.3%, topical ophthalmic formulation, single instillation
Other Name: Systane(R)
- Noninvasive Tear Film Break-up Time [ Time Frame: 15 minutes after eye drop instillation ]State-of-the-art methodology to assess tear stability.
- Fluorescein Tear Film Break-up Time [ Time Frame: 120 minutes after eye drops instillation ]Standard clinical assessment methodology for assessing tear stability.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00681265
|United States, New York|
|University of Rochester Eye Institute|
|Rochester, New York, United States, 14642|
|Principal Investigator:||James V. Aquavella, MD||University of Rochester Eye Institute|