Tear Film Break-up Time After Instillation of Artificial Tears

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eyeon Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT00681265
First received: May 19, 2008
Last updated: October 24, 2012
Last verified: October 2012
Results First Received: September 16, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Keratoconjunctivitis Sicca
Interventions: Drug: glycerin
Drug: polyethylene glycol 400/propylene glycol

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Dates: 5/18/2008 to 8/30/2008. Single site: Flaum Eye Institute at the University of Rochester.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Glycerin Eye Drop / PEG 400 and Propylene Glycol Eye Drop 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.

Participant Flow:   Overall Study
    Glycerin Eye Drop / PEG 400 and Propylene Glycol Eye Drop  
STARTED     16  
COMPLETED     16  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Glycerin Eye Drop / PEG 400 and Propylene Glycol Eye Drop 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.

Baseline Measures
    Glycerin Eye Drop / PEG 400 and Propylene Glycol Eye Drop  
Number of Participants  
[units: participants]
  16  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     16  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  44.5  ± 10.8  
Gender  
[units: participants]
 
Female     10  
Male     6  
Region of Enrollment  
[units: participants]
 
United States     16  



  Outcome Measures
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1.  Primary:   Noninvasive Tear Film Break-up Time   [ Time Frame: 15 minutes after eye drop instillation ]

2.  Secondary:   Fluorescein Tear Film Break-up Time   [ Time Frame: 120 minutes after eye drops instillation ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: David M. Kleinman
Organization: Eyeon Therapeutics, Inc.
phone: n/a
e-mail: dave@eyeontherapeutics.com


Publications:

Responsible Party: Eyeon Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT00681265     History of Changes
Other Study ID Numbers: ET-001
Study First Received: May 19, 2008
Results First Received: September 16, 2012
Last Updated: October 24, 2012
Health Authority: United States: Institutional Review Board