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

Sponsor

Medical University of Vienna (Other)

Overall Status

Completed

CT.gov ID

NCT01970917

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

15.7

Patients Per Site Per Month

Study Details

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.

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

Study Design

Study Type:

Interventional

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 :

Oct 1, 2013

Actual Primary Completion Date :

Nov 1, 2013

Actual Study Completion Date :

Nov 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Other: 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
Other: 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

Arm

Intervention/Treatment

Other: 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

Other: 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

Primary Outcome Measures

Tear film thickness [up to one hour]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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