Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
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

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment Phase
Dry Eye Syndrome Healthy Device: Olixia pure eye drops Device: Placebo Phase 4

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effect of Olixia Pure® Eye Drops on Tear Film Thickness in Healthy Subjects
Study Start Date : October 2013
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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.
 Device: Olixia pure eye drops
Device: Placebo
0.9% physiological saline solution
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.
 Device: Olixia pure eye drops
Device: Placebo
0.9% physiological saline solution


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Tear film thickness [ Time Frame: up to one hour ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01970917


Locations
Layout table for location information
Austria
Department of Clinical Pharmacology
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Investigators
Layout table for investigator information
Principal Investigator: Gerhard Garhoefer, MD Department of Clinical Pharmacology, Medical University of Vienna
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Gerhard Garhofer, Assoc. Prof. PD Dr., Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01970917    
Other Study ID Numbers: OPHT-190313
First Posted: October 28, 2013    Key Record Dates
Last Update Posted: November 27, 2013
Last Verified: November 2013
Keywords provided by Gerhard Garhofer, Medical University of Vienna:
tear film thickness
optical coherence tomography
topical lubricants
tear film thickness in healthy subjects
Additional relevant MeSH terms:
Layout table for MeSH terms
Dry Eye Syndromes
Lacrimal Apparatus Diseases
Eye Diseases
Ophthalmic Solutions
Pharmaceutical Solutions