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

Tracking Information

First Received Date ^ICMJE

May 19, 2008

Last Updated Date

October 24, 2012

Start Date ^ICMJE

June 2008

Primary Completion Date

August 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

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

Change History

Complete list of historical versions of study NCT00681265 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

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

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Tear Film Break-up Time After Instillation of Artificial Tears

Official Title ^ICMJE

A Randomized, Masked Exploratory Trial Comparing the Effect of Two Different Over-the-Counter Artificial Tear Preparations on Tear Film Break-up Time

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.

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 ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Keratoconjunctivitis Sicca

Intervention ^ICMJE

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)

Study Arm (s)

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

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

August 2008

Primary Completion Date

August 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00681265

Other Study ID Numbers ^ICMJE

ET-001

Has Data Monitoring Committee

Responsible Party

Eyeon Therapeutics, Inc.

Study Sponsor ^ICMJE

Eyeon Therapeutics, Inc.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

James V. Aquavella, MD

University of Rochester Eye Institute

Information Provided By

Eyeon Therapeutics, Inc.

Verification Date

October 2012

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

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