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

Not Applicable

Completed

• Conditions: Dry Eye Syndromes
• Interventions: Device: Povidone; Device: REMOGEN OMEGA

• Registration Number: NCT02908282
• Lead Sponsor: TRB Chemedica AG

Brief Summary

The primary objective of this study is to evaluate the efficacy of REMOGEN® OMEGA in reducing Dry Eye Syndrome (DES) symptoms.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-09-13
• Study First Submitted QC: 2016-09-16
• Study First Posted: 2016-09-20
• Study Start: 2016-10
• Primary Completion: 2018-07
• Study Completion: 2018-07
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-14
• Last Update Posted: 2018-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
C (control)-group	Povidone	Povidone: Usage according to instructions for use.
PUFA (polyunsaturated fatty acids)-group	REMOGEN OMEGA	REMOGEN OMEGA: Usage according to instructions for use.

Primary Outcome Measures

Name	Time	Method
Tear film stability	Week 4	Tear film breakup time (unit: seconds)
Ocular Surface Disease Index (OSDI©) questionnaire	Week 4

Secondary Outcome Measures

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

Trial Locations

Locations (5)

Praxis Prof. Dr. Anselm Kampik & Kollegen; 🇩🇪 Munich, Bavaria, Germany

Augenzentrum Olching; 🇩🇪 Olching, Bavaria, Germany

Praxis Dr. Kaercher; 🇩🇪 Heidelberg, Baden-Württemberg, Germany

Augenheilkunde Lindenthal; 🇩🇪 Köln-Lindenthal, Nordrhein-Westfalen, Germany

Dr. Flamm & Böker: Augenärzte am Tibarg; 🇩🇪 Hamburg, Germany