Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Olixia Pure® Eye Drops on Tear Film Thickness in Healthy Subjects

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: NCT01970917
Recruitment Status : Completed
First Posted : October 28, 2013
Last Update Posted : November 27, 2013
Sponsor:
Information provided by (Responsible Party):
Gerhard Garhofer, Medical University of Vienna

Tracking Information
First Submitted Date  ICMJE July 11, 2013
First Posted Date  ICMJE October 28, 2013
Last Update Posted Date November 27, 2013
Study Start Date  ICMJE October 2013
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 25, 2013)
Tear film thickness [ Time Frame: up to one hour ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Olixia Pure® Eye Drops on Tear Film Thickness in Healthy Subjects
Official Title  ICMJE Effect of Olixia Pure® Eye Drops on Tear Film Thickness in Healthy Subjects
Brief Summary

Dry eye syndrome (DES) is a common ocular disease, especially in the elderly population. Despite many treatment approaches, instillation of topical lubricants remains the mainstay of therapy. However, most of the topical lubricants available are not very well characterized and data about efficacy is sparse.

The aim of the present project is to investigate the effect of topically administered Olixia pure® eye drops on tear film thickness in healthy subjects.

Tear film thickness will be determined using ultra high-resolution optical coherence tomography (OCT). Measurements will be performed before instillation of the eye drops and every 10 minutes after instillation for one hour. One eye will receive Olixia pure® eye drops, the fellow eye will receive physiologic saline solution as placebo control. The study eye will be chosen randomly.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE
  • Dry Eye Syndrome
  • Healthy
Intervention  ICMJE
  • Device: Olixia pure eye drops
  • Device: Placebo
    0.9% physiological saline solution
Study Arms  ICMJE
  • Healthy volunteers right eye
    The medical device will be randomly assigned to the right or left eye on the study day (randomization 1:1) whereas the fellow eye will receive placebo.
    Interventions:
    • Device: Olixia pure eye drops
    • Device: Placebo
  • Healthy volunteers left eye
    The medical device will be randomly assigned to the right or left eye on the study day (randomization 1:1) whereas the fellow eye will receive placebo.
    Interventions:
    • Device: Olixia pure eye drops
    • Device: Placebo
Publications * Not Provided

*   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
 (submitted: October 25, 2013)
16
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2013
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Men and women aged over 18 years
  • Normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant
  • Normal ophthalmic findings, ametropia < 6 Dpt.
  • Schirmer I test > 10 mm and BUT > 10 sec

Exclusion Criteria:

  • Regular use of medication (except contraceptives), abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
  • Treatment in the previous 3 weeks with any drug
  • Symptoms of a clinically relevant illness in the 3 weeks before the first study day
  • Ametropia =/> 6 Dpt
  • Pregnancy
  • Difference of more than 5 mm in Schirmer I test or difference of > 3 sec in BUT between the two eyes
  • Known medical history of allergy, hypersensitivity or poor tolerance to any components of the medication or medical product used in the study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01970917
Other Study ID Numbers  ICMJE OPHT-190313
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gerhard Garhofer, Medical University of Vienna
Study Sponsor  ICMJE Medical University of Vienna
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gerhard Garhoefer, MD Department of Clinical Pharmacology, Medical University of Vienna
PRS Account Medical University of Vienna
Verification Date November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP