Tear Film Break-up Time After Instillation of Artificial Tears
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|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|