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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01970917
• Other study ID #: OPHT-190313
• Status: Completed
• Phase: Phase 4
• First received: July 11, 2013
• Last updated: November 26, 2013
• Start date: October 2013
• Est. completion date: November 2013

Study information

• Verified date: November 2013
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Austrian Federal Office for Safety in Health Care
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Dry Eye Syndrome
• Dry Eye Syndromes
• Healthy
• Keratoconjunctivitis Sicca

Intervention

Device:
• Olixia pure eye drops

• Placebo
0.9% physiological saline solution

Locations

Country	Name	City	State
Austria	Department of Clinical Pharmacology	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tear film thickness		up to one hour	No