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

• ClinicalTrials.gov Identifier: NCT01970917
• Recruitment Status: Completed
• First Posted: October 28, 2013
• Last Update Posted: November 27, 2013
• Sponsor: Medical University of Vienna
• Information provided by (Responsible Party): Gerhard Garhofer, Medical University of Vienna

Tracking Information

• First Submitted Date: July 11, 2013
• First Posted Date: October 28, 2013
• Last Update Posted Date: November 27, 2013
• Study Start Date: October 2013
• Actual Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: October 25, 2013): Tear film thickness [ Time Frame: up to one hour ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effect of Olixia Pure® Eye Drops on Tear Film Thickness in Healthy Subjects
• Official Title: Effect of Olixia Pure® Eye Drops on 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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Single Group Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Basic Science

Condition

• Dry Eye Syndrome
• Healthy

Intervention

• Device: Olixia pure eye drops
• Device: Placebo
  0.9% physiological saline solution

Study Arms

• Healthy volunteers right eye
  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.
  Interventions:

  • Device: Olixia pure eye drops
  • Device: Placebo
• Healthy volunteers left eye
  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.
  Interventions:

  • Device: Olixia pure eye drops
  • Device: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 25, 2013): 16
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: November 2013
• Actual Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Austria

Administrative Information

• NCT Number: NCT01970917
• Other Study ID Numbers: OPHT-190313
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Gerhard Garhofer, Medical University of Vienna
• Study Sponsor: Medical University of Vienna
• Collaborators: Not Provided

Investigators

• Principal Investigator: Gerhard Garhoefer, MD; Department of Clinical Pharmacology, Medical University of Vienna

• PRS Account: Medical University of Vienna
• Verification Date: November 2013