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

Dry Eye Syndromes Clinical Trial

— REMOTOP  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02908282
• Other study ID #: REMODES-DE-2015-12
• Status: Completed
• Phase: N/A
• Start date: October 2016
• Est. completion date: July 2018

Study information

• Verified date: August 2018
• Source: TRB Chemedica AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: July 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 81 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

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.
• Povidone
Artificial tears: preservative-free eye drops containing 2% povidone.

Locations

Country	Name	City	State
Germany	Dr. Flamm & Böker: Augenärzte am Tibarg	Hamburg
Germany	Praxis Dr. Kaercher	Heidelberg	Baden-Württemberg
Germany	Augenheilkunde Lindenthal	Köln-Lindenthal	Nordrhein-Westfalen
Germany	Praxis Prof. Dr. Anselm Kampik & Kollegen	Munich	Bavaria
Germany	Augenzentrum Olching	Olching	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
TRB Chemedica AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ocular Surface Disease Index (OSDI©) questionnaire		Week 4
Primary	Tear film stability	Tear film breakup time (unit: seconds)	Week 4
Secondary	OSDI questionnaire		Day 0, Week 12
Secondary	Tear film stability	Tear film breakup time (unit: seconds)	Day 0, Week 12
Secondary	Visual acuity (best corrected)		Day 0, Week 4, Week 12
Secondary	TearLab osmolarity test		Day 0, Week 4, Week 12
Secondary	Inflammation marker matrix metalloproteinase 9 (MMP9)		Day 0, Week 4, Week 12
Secondary	Lid-parallel conjunctival fold (LIPCOF) grading		Day 0, Week 4, Week 12
Secondary	Corneal staining	Oxford grading scale	Day 0, Week 4, Week 12
Secondary	Tear volume	Schirmer test	Day 0, Week 4, Week 12
Secondary	Conjunctival staining	Oxford grading scale	Day 0, Week 4, Week 12