Effect of Olixia Pure® Eye Drops on Tear Film Thickness in Healthy Subjects
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ClinicalTrials.gov Identifier: NCT01970917 |
Recruitment Status :
Completed
First Posted : October 28, 2013
Last Update Posted : November 27, 2013
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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 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 |
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.
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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 |
- Tear film thickness [ Time Frame: up to one hour ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
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

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
Austria | |
Department of Clinical Pharmacology | |
Vienna, Austria, 1090 |
Principal Investigator: | Gerhard Garhoefer, MD | Department of Clinical Pharmacology, Medical University of Vienna |
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 |
tear film thickness optical coherence tomography topical lubricants tear film thickness in healthy subjects |
Dry Eye Syndromes Lacrimal Apparatus Diseases Eye Diseases Ophthalmic Solutions Pharmaceutical Solutions |