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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00681265
Other study ID # ET-001
Secondary ID
Status Completed
Phase N/A
First received May 19, 2008
Last updated October 24, 2012
Start date June 2008
Est. completion date August 2008

Study information

Verified date October 2012
Source Eyeon Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 16
Est. completion date August 2008
Est. primary completion date August 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

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


Intervention

Drug:
glycerin
Eye drop with active agent glycerin 1%, new topical ophthalmic formulation with polylysine-graft-polyethylene glycol as an excipient, single instillation.
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

Locations

Country Name City State
United States University of Rochester Eye Institute Rochester New York

Sponsors (1)

Lead Sponsor Collaborator
Eyeon Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (3)

Cho P, Douthwaite W. The relation between invasive and noninvasive tear break-up time. Optom Vis Sci. 1995 Jan;72(1):17-22. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Noninvasive Tear Film Break-up Time State-of-the-art methodology to assess tear stability. 15 minutes after eye drop instillation No
Secondary Fluorescein Tear Film Break-up Time Standard clinical assessment methodology for assessing tear stability. 120 minutes after eye drops instillation No
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