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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
History of Changes
  Purpose

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 Intervention
Keratoconjunctivitis Sicca
 Drug: glycerin
Drug: polyethylene glycol 400/propylene glycol

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Eyeon Therapeutics, Inc.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 16
Study Start Date: June 2008
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:

Responsible Party: Eyeon Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT00681265     History of Changes
Other Study ID Numbers: ET-001
Study First Received: May 19, 2008
Results First Received: September 16, 2012
Last Updated: October 24, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Eyeon Therapeutics, Inc.:
ocular lubricants

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
 Corneal Diseases
Lacrimal Apparatus Diseases
Glycerol
Cryoprotective Agents
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013