Tear Film Break-up Time After Instillation of Artificial Tears - Full Text View

Sponsored by:	Eyeon Therapeutics, Inc.
Information provided by:	Eyeon Therapeutics, Inc.
ClinicalTrials.gov Identifier:	NCT00681265

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

MedlinePlus related topics: Over-the-Counter Medicines

Drug Information available for: Glycerol Propylene glycol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Single Group Assignment, Efficacy Study
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

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

Primary Outcome Measures:

Noninvasive tear film break-up time [ Time Frame: 15, 30, 60, 120 minutes after eye drop instillation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Fluorescein tear film break-up time [ Time Frame: 120 minutes ] [ Designated as safety issue: No ]

Enrollment:	18
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
Treated eye: Experimental One eye will randomly receive a single instillation of a drop of artificial tear A.	Drug: glycerin Eye drop with active agent glycerin 1%, topical ophthalmic formulation, single instillation.
Fellow eye: Active Comparator The other eye will receive a single instillation of one drop of artificial tear B.	Drug: polyethylene glycol 400/propylene glycol Eye drop with the active agents polyethylene glycol 400 0.4% and propylene glycol 0.3%, topical ophthalmic formulation, single 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:

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.

Responsible Party:	Eyeon Therapeutics, Inc. ( David M. Kleinman, MD/President )
Study ID Numbers:	ET-001
Study First Received:	May 19, 2008
Last Updated:	September 21, 2008
ClinicalTrials.gov Identifier:	NCT00681265 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Eyeon Therapeutics, Inc.:

ocular lubricants

Study placed in the following topic categories:

Lacerations
Corneal Diseases
Eye Diseases
Lacrimal Apparatus Diseases
Dry Eye Syndromes
Conjunctivitis
Tetrahydrozoline

Keratoconjunctivitis
Conjunctival Diseases
Glycerol
Xerophthalmia
Keratitis
Keratoconjunctivitis Sicca

Additional relevant MeSH terms:

Corneal Diseases
Eye Diseases
Physiological Effects of Drugs
Lacrimal Apparatus Diseases
Dry Eye Syndromes
Conjunctivitis
Keratoconjunctivitis
Cryoprotective Agents

Protective Agents
Pharmacologic Actions
Conjunctival Diseases
Glycerol
Xerophthalmia
Keratitis
Keratoconjunctivitis Sicca

ClinicalTrials.gov processed this record on May 07, 2009