Tear Film Break-up Time After Instillation of Artificial Tears

Keratoconjunctivitis Sicca Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00681265
• Other study ID #: ET-001
• 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

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Keratoconjunctivitis
• Keratoconjunctivitis Sicca

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