Tear Film Break-up Time After Instillation of Artificial Tears

Tracking Information
First Submitted Date ICMJE	May 19, 2008
First Posted Date ICMJE	May 21, 2008
Results First Submitted Date	September 16, 2012
Results First Posted Date	October 26, 2012
Last Update Posted Date	October 26, 2012
Study Start Date ICMJE	June 2008
Actual Primary Completion Date	August 2008 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: October 24, 2012)	Noninvasive Tear Film Break-up Time [ Time Frame: 15 minutes after eye drop instillation ]; State-of-the-art methodology to assess tear stability.
Original Primary Outcome Measures ICMJE; (submitted: May 20, 2008)	Noninvasive Tear Film Break-up Time [ Time Frame: 15, 30, 60, 120 minutes after eye drop instillation ]
Change History	Complete list of historical versions of study NCT00681265 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: October 24, 2012)	Fluorescein Tear Film Break-up Time [ Time Frame: 120 minutes after eye drops instillation ]; Standard clinical assessment methodology for assessing tear stability.
Original Secondary Outcome Measures ICMJE; (submitted: May 20, 2008)	Fluorescein Tear Film Break-up Time [ Time Frame: 120 minutes ]
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Tear Film Break-up Time After Instillation of Artificial Tears
Official Title ICMJE	A Randomized, Masked Exploratory Trial Comparing the Effect of Two Different Over-the-Counter Artificial Tear Preparations on Tear Film Break-up Time
Brief Summary	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.
Detailed Description	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.
Study Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Single Group Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
Condition ICMJE	Keratoconjunctivitis Sicca
Intervention ICMJE	Drug: glycerin 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); 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)
Study Arms	Experimental: glycerin 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. Intervention: Drug: glycerin; 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. Intervention: Drug: polyethylene glycol 400/propylene glycol
Publications *	Nichols JJ, Nichols KK, Puent B, Saracino M, Mitchell GL. Evaluation of tear film interference patterns and measures of tear break-up time. Optom Vis Sci. 2002 Jun;79(6):363-9.; Ousler GW, Michaelson C, Christensen MT. An evaluation of tear film breakup time extension and ocular protection index scores among three marketed lubricant eye drops. Cornea. 2007 Sep;26(8):949-52.; Cho P, Douthwaite W. The relation between invasive and noninvasive tear break-up time. Optom Vis Sci. 1995 Jan;72(1):17-22.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: October 24, 2012)	16
Original Estimated Enrollment ICMJE; (submitted: May 20, 2008)	15
Actual Study Completion Date	August 2008
Actual Primary Completion Date	August 2008 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	Yes
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00681265
Other Study ID Numbers ICMJE	ET-001
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Eyeon Therapeutics, Inc.
Study Sponsor ICMJE	Eyeon Therapeutics, Inc.
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: James V. Aquavella, MD University of Rochester Eye Institute
PRS Account	Eyeon Therapeutics, Inc.
Verification Date	October 2012
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP