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Tear Film Break-up Time After Instillation of Artificial Tears

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00681265
First Posted: May 21, 2008
Last Update Posted: October 26, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Eyeon Therapeutics, Inc.
May 19, 2008
May 21, 2008
September 16, 2012
October 26, 2012
October 26, 2012
June 2008
August 2008   (Final data collection date for primary outcome measure)
Noninvasive Tear Film Break-up Time [ Time Frame: 15 minutes after eye drop instillation ]
State-of-the-art methodology to assess tear stability.
Noninvasive Tear Film Break-up Time [ Time Frame: 15, 30, 60, 120 minutes after eye drop instillation ]
Complete list of historical versions of study NCT00681265 on ClinicalTrials.gov Archive Site
Fluorescein Tear Film Break-up Time [ Time Frame: 120 minutes after eye drops instillation ]
Standard clinical assessment methodology for assessing tear stability.
Fluorescein Tear Film Break-up Time [ Time Frame: 120 minutes ]
Not Provided
Not Provided
 
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
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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Keratoconjunctivitis Sicca
  • 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)
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
August 2008
August 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00681265
ET-001
No
Not Provided
Not Provided
Eyeon Therapeutics, Inc.
Eyeon Therapeutics, Inc.
Not Provided
Principal Investigator: James V. Aquavella, MD University of Rochester Eye Institute
Eyeon Therapeutics, Inc.
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP