Tear Film Break-up Time After Instillation of Artificial Tears

Not Applicable

Completed

• Conditions: Keratoconjunctivitis Sicca
• Interventions: Drug: glycerin; Drug: polyethylene glycol 400/propylene glycol

• Registration Number: NCT00681265
• Lead Sponsor: Calm Water Therapeutics LLC

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 Timeline

• Study First Submitted: 2008-05-19
• Study First Submitted QC: 2008-05-20
• Study First Posted: 2008-05-21
• Study Start: 2008-06
• Primary Completion: 2008-08
• Study Completion: 2008-08
• Results First Submitted: 2012-09-16
• Status Verified: 2012-10
• Results First Submitted QC: 2012-10-24
• Last Update Submitted: 2012-10-24
• Results First Posted: 2012-10-26
• Last Update Posted: 2012-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
glycerin	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.
polyethylene glycol 400/propylene glycol	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.

Primary Outcome Measures

Name	Time	Method
Noninvasive Tear Film Break-up Time	15 minutes after eye drop instillation	State-of-the-art methodology to assess tear stability.

Secondary Outcome Measures

Name	Time	Method
Fluorescein Tear Film Break-up Time	120 minutes after eye drops instillation	Standard clinical assessment methodology for assessing tear stability.

Trial Locations

Locations (1)

University of Rochester Eye Institute; 🇺🇸 Rochester, New York, United States