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

Primary Purpose

Dry Eye Syndrome, Healthy

Status
Completed
Phase
Phase 4
Locations
Austria
Study Type
Interventional
Intervention
Olixia pure eye drops
Placebo
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Dry Eye Syndrome focused on measuring tear film thickness, optical coherence tomography, topical lubricants, tear film thickness in healthy subjects

Eligibility Criteria

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

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

Sites / Locations

  • Department of Clinical Pharmacology

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Healthy volunteers right eye

Healthy volunteers left eye

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Tear film thickness

Secondary Outcome Measures

Full Information

First Posted
July 11, 2013
Last Updated
November 26, 2013
Sponsor
Medical University of Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT01970917
Brief Title
Effect of Olixia Pure® Eye Drops on Tear Film Thickness in Healthy Subjects
Official Title
Effect of Olixia Pure® Eye Drops on Tear Film Thickness in Healthy Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndrome, Healthy
Keywords
tear film thickness, optical coherence tomography, topical lubricants, tear film thickness in healthy subjects

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healthy volunteers right eye
Arm Type
Other
Arm Description
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.
Arm Title
Healthy volunteers left eye
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Olixia pure eye drops
Intervention Type
Device
Intervention Name(s)
Placebo
Intervention Description
0.9% physiological saline solution
Primary Outcome Measure Information:
Title
Tear film thickness
Time Frame
up to one hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerhard Garhoefer, MD
Organizational Affiliation
Department of Clinical Pharmacology, Medical University of Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Clinical Pharmacology
City
Vienna
ZIP/Postal Code
1090
Country
Austria

12. IPD Sharing Statement

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

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