Tear Film Break-up Time After Instillation of Artificial Tears
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00681265 |
Recruitment Status
:
Completed
First Posted
: May 21, 2008
Results First Posted
: October 26, 2012
Last Update Posted
: October 26, 2012
|
Sponsor:
Eyeon Therapeutics, Inc.
Information provided by (Responsible Party):
Eyeon Therapeutics, Inc.
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Tracking Information | ||||
---|---|---|---|---|
First Submitted Date ICMJE | May 19, 2008 | |||
First Posted Date ICMJE | May 21, 2008 | |||
Results First Submitted Date | September 16, 2012 | |||
Results First Posted Date | October 26, 2012 | |||
Last Update Posted Date | October 26, 2012 | |||
Study Start Date ICMJE | June 2008 | |||
Actual 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 ] 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 ] | |||
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 ] Standard clinical assessment methodology for assessing tear stability.
|
|||
Original Secondary Outcome Measures ICMJE |
Fluorescein Tear Film Break-up Time [ Time Frame: 120 minutes ] | |||
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 Applicable | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment |
|||
Condition ICMJE | Keratoconjunctivitis Sicca | |||
Intervention ICMJE |
|
|||
Study Arms |
|
|||
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 | |||
Actual Enrollment ICMJE |
16 | |||
Original Estimated Enrollment ICMJE |
15 | |||
Actual Study Completion Date | August 2008 | |||
Actual Primary Completion Date | August 2008 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
|||
Sex/Gender |
|
|||
Ages | 18 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00681265 | |||
Other Study ID Numbers ICMJE | ET-001 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Eyeon Therapeutics, Inc. | |||
Study Sponsor ICMJE | Eyeon Therapeutics, Inc. | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
|
|||
PRS Account | 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 |