Topical Omega-3 Fatty Acids (REMOGEN® OMEGA) in the Treatment of Dry Eye (REMOTOP)

August 14, 2018 updated by: TRB Chemedica AG
The primary objective of this study is to evaluate the efficacy of REMOGEN® OMEGA in reducing Dry Eye Syndrome (DES) symptoms.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

81

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hamburg, Germany, 22459
        • Dr. Flamm & Böker: Augenärzte am Tibarg
    • Baden-Württemberg
      • Heidelberg, Baden-Württemberg, Germany, 69121
        • Praxis Dr. Kaercher
    • Bavaria
      • Munich, Bavaria, Germany, 80333
        • Praxis Prof. Dr. Anselm Kampik & Kollegen
      • Olching, Bavaria, Germany, 82140
        • Augenzentrum Olching
    • Nordrhein-Westfalen
      • Köln-Lindenthal, Nordrhein-Westfalen, Germany, 50931
        • Augenheilkunde Lindenthal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 81 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female patient between 18 and 80 years of age and in good general health condition.
  • Signed written informed consent.
  • Existence of moderate to severe DES symptoms defined as Break-up time (TBUT) ≤ 10 s (mean of 3 consecutive measurements) and OSDI questionnaire ≥ 20.

Exclusion Criteria:

  • Contraindication for the use of the products (e.g. hypersensitivity to the constituents of the test products) or any study procedure.
  • Concomitant or previous participation in a clinical investigation within the last 3 months.
  • Concomitant therapies/manipulations that affect either the tear film, tear secretion or ocular surface integrity or would alter the effect of the devices being evaluated.
  • Concurrent (systemic) DES-associated diseases that are not on a stable therapy since at least 1 month (therapy not expected to change)
  • Glaucoma that is not on a stable dosage since at least 2 weeks (therapy not expected to change)
  • Any diseases or characteristics judged by the investigator to be incompatible with the assessments and/or procedures for the study evaluation
  • Pregnant or lactating females.
  • Participants of childbearing age who do not use adequate methods of birth control.
  • Subjects unable to understand the informed consent or having a high probability of noncompliance to the study procedures and/or non-completion of the study according to investigator's judgment (e.g. illiteracy, insufficient knowledge of local language).
  • Subjects not capable of contracting and of understanding the nature, risks, significance and implications of the clinical investigation and unable to form a rational intention in the light of these facts.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: PUFA (polyunsaturated fatty acids)-group
REMOGEN OMEGA: Usage according to instructions for use.
Device: REMOGEN OMEGA
Lubricant eye drops: preservative-free, hypotonic microemulsion of polyunsaturated fatty acids and hydrating polymers provided in single-dose containers of 0.25 ml.
Other: C (control)-group
Povidone: Usage according to instructions for use.
Device: Povidone
Artificial tears: preservative-free eye drops containing 2% povidone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ocular Surface Disease Index (OSDI©) questionnaire
Time Frame: Week 4
Week 4
Tear film stability
Time Frame: Week 4
Tear film breakup time (unit: seconds)
Week 4

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OSDI questionnaire
Time Frame: Day 0, Week 12
Day 0, Week 12
Tear film stability
Time Frame: Day 0, Week 12
Tear film breakup time (unit: seconds)
Day 0, Week 12
Visual acuity (best corrected)
Time Frame: Day 0, Week 4, Week 12
Day 0, Week 4, Week 12
TearLab osmolarity test
Time Frame: Day 0, Week 4, Week 12
Day 0, Week 4, Week 12
Inflammation marker matrix metalloproteinase 9 (MMP9)
Time Frame: Day 0, Week 4, Week 12
Day 0, Week 4, Week 12
Lid-parallel conjunctival fold (LIPCOF) grading
Time Frame: Day 0, Week 4, Week 12
Day 0, Week 4, Week 12
Corneal staining
Time Frame: Day 0, Week 4, Week 12
Oxford grading scale
Day 0, Week 4, Week 12
Tear volume
Time Frame: Day 0, Week 4, Week 12
Schirmer test
Day 0, Week 4, Week 12
Conjunctival staining
Time Frame: Day 0, Week 4, Week 12
Oxford grading scale
Day 0, Week 4, Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TRB Chemedica AG

Investigators

  • Principal Investigator: Thomas Kaercher, Dr., Praxis Dr. Thomas Kaercher

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (Actual)

July 1, 2018

Study Completion (Actual)

July 1, 2018

Study Registration Dates

First Submitted

September 13, 2016

First Submitted That Met QC Criteria

September 16, 2016

First Posted (Estimate)

September 20, 2016

Study Record Updates

Last Update Posted (Actual)

August 15, 2018

Last Update Submitted That Met QC Criteria

August 14, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REMODES-DE-2015-12

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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