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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
Sponsor:
Information provided by (Responsible Party):
Eyeon Therapeutics, Inc.

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.

Condition or disease Intervention/treatment Phase
Keratoconjunctivitis Sicca Drug: glycerin Drug: polyethylene glycol 400/propylene glycol Not Applicable

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 : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Care Tears
U.S. FDA Resources

Arm Intervention/treatment
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.
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)
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)



Primary Outcome Measures :
  1. Noninvasive Tear Film Break-up Time [ Time Frame: 15 minutes after eye drop instillation ]
    State-of-the-art methodology to assess tear stability.


Secondary Outcome Measures :
  1. Fluorescein Tear Film Break-up Time [ Time Frame: 120 minutes after eye drops instillation ]
    Standard clinical assessment methodology for assessing tear stability.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

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


Locations
United States, New York
University of Rochester Eye Institute
Rochester, New York, United States, 14642
Sponsors and Collaborators
Eyeon Therapeutics, Inc.
Investigators
Principal Investigator: James V. Aquavella, MD University of Rochester Eye Institute

Publications:
Responsible Party: Eyeon Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT00681265     History of Changes
Other Study ID Numbers: ET-001
First Posted: May 21, 2008    Key Record Dates
Results First Posted: October 26, 2012
Last Update Posted: October 26, 2012
Last Verified: October 2012

Keywords provided by Eyeon Therapeutics, Inc.:
ocular lubricants

Additional relevant MeSH terms:
Keratoconjunctivitis
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Glycerol
Lubricant Eye Drops
Cryoprotective Agents
Protective Agents
Physiological Effects of Drugs
Ophthalmic Solutions
Pharmaceutical Solutions