Tear Film Break-up Time After Instillation of Artificial Tears

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eyeon Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT00681265
First received: May 19, 2008
Last updated: October 24, 2012
Last verified: October 2012

May 19, 2008
October 24, 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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Standard clinical assessment methodology for assessing tear stability.
Fluorescein tear film break-up time [ Time Frame: 120 minutes ] [ Designated as safety issue: No ]
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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, 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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00681265
ET-001
No
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