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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01970917

Enrollment

Registered

2013-10-28

Start date

2013-10-31

Completion date

2013-11-30

Last updated

2013-11-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Eye Syndrome, Healthy

Keywords

tear film thickness, optical coherence tomography, topical lubricants, 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.

Interventions

DEVICEOlixia pure eye drops

DEVICEPlacebo

0.9% physiological saline solution

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Tear film thickness	up to one hour

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026