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Completed

NCT Number: NCT01970917

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

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.

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Key information

Conditions

Dry Eye Syndrome Dry Eye Syndromes Eye Diseases Healthy Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Clinical Pharmacology

Vienna, State of Vienna, 1090, Austria

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Olixia pure eye drops

Device

PLACEBO

Device

0.9% physiological saline solution

Primary outcomes

  1. Tear film thickness

    Time frame: up to one hour

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Oct 28, 2013
Registry last updated
Nov 27, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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