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

Phase 4CompletedNCT01970917

Medical University of Vienna16 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Enrollment

Conditions

Dry Eye Syndrome Healthy

Interventions

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes