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

NCT01970917 | Completed Phase 4 DMC

• 1 other identifier: OPHT-190313
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry Eye Syndrome; Healthy

Keywords

tear film thickness; optical coherence tomography; topical lubricants; tear film thickness in healthy subjects

Outcome Measures

Primary Outcomes (1)

• Tear film thickness

  up to one hour

Study Arms (2)

Healthy volunteers right eye

OTHER

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

Healthy volunteers left eye

OTHER

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

Interventions

Olixia pure eye drops DEVICE

Healthy volunteers left eye; Healthy volunteers right eye

Placebo DEVICE

0.9% physiological saline solution

Healthy volunteers left eye; Healthy volunteers right eye

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Department of Clinical Pharmacology

Vienna, Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Gerhard Garhoefer, MD

  Department of Clinical Pharmacology, Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. PD Dr.

Study Record Dates

• First Submitted: July 11, 2013
• First Posted: October 28, 2013
• Study Start: October 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: November 27, 2013

Record last verified: 2013-11

Locations

AU (1)