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Tear Film Break-up Time After Instillation of Artificial Tears

Primary Purpose

Keratoconjunctivitis Sicca

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
glycerin
polyethylene glycol 400/propylene glycol
Sponsored by
Calm Water Therapeutics LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Keratoconjunctivitis Sicca focused on measuring ocular lubricants

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Rochester Eye Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

glycerin

polyethylene glycol 400/propylene glycol

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Noninvasive Tear Film Break-up Time
State-of-the-art methodology to assess tear stability.

Secondary Outcome Measures

Fluorescein Tear Film Break-up Time
Standard clinical assessment methodology for assessing tear stability.

Full Information

First Posted
May 19, 2008
Last Updated
October 24, 2012
Sponsor
Calm Water Therapeutics LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00681265
Brief Title
Tear Film Break-up Time After Instillation of Artificial Tears
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Calm Water Therapeutics LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratoconjunctivitis Sicca
Keywords
ocular lubricants

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
glycerin
Arm Type
Experimental
Arm Description
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.
Arm Title
polyethylene glycol 400/propylene glycol
Arm Type
Active Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
glycerin
Other Intervention Name(s)
Eyeon Protect(TM)
Intervention Description
Eye drop with active agent glycerin 1%, new topical ophthalmic formulation with polylysine-graft-polyethylene glycol as an excipient, single instillation.
Intervention Type
Drug
Intervention Name(s)
polyethylene glycol 400/propylene glycol
Other Intervention Name(s)
Systane(R)
Intervention Description
Eye drop with the active agents polyethylene glycol 400 0.4% /propylene glycol 0.3%, topical ophthalmic formulation, single instillation
Primary Outcome Measure Information:
Title
Noninvasive Tear Film Break-up Time
Description
State-of-the-art methodology to assess tear stability.
Time Frame
15 minutes after eye drop instillation
Secondary Outcome Measure Information:
Title
Fluorescein Tear Film Break-up Time
Description
Standard clinical assessment methodology for assessing tear stability.
Time Frame
120 minutes after eye drops instillation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James V. Aquavella, MD
Organizational Affiliation
University of Rochester Eye Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Rochester Eye Institute
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
12086302
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. doi: 10.1097/00006324-200206000-00009.
Results Reference
background
PubMed Identifier
17721294
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. doi: 10.1097/ICO.0b013e3180de1c38.
Results Reference
background
PubMed Identifier
7731650
Citation
Cho P, Douthwaite W. The relation between invasive and noninvasive tear break-up time. Optom Vis Sci. 1995 Jan;72(1):17-22. doi: 10.1097/00006324-199501000-00004.
Results Reference
background

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Tear Film Break-up Time After Instillation of Artificial Tears

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