Clinical trial NCT02908282: Topical Omega-3 Fatty Acids (REMOGEN® OMEGA) in the Treatment of Dry Eye
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye Syndromes
Keywords: tear film
omega-3 fatty acids
eye drops
Lead sponsor: TRB Chemedica AG
Sponsor class: INDUSTRY
First posted: 2016-09-20
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 81
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Ocular Surface Disease Index (OSDI©) questionnaire
timeFrame: Week 4
measure: Tear film stability
timeFrame: Week 4
Secondary outcomes:
measure: OSDI questionnaire
timeFrame: Day 0, Week 12
measure: Tear film stability
timeFrame: Day 0, Week 12
measure: Visual acuity (best corrected)
timeFrame: Day 0, Week 4, Week 12
measure: TearLab osmolarity test
timeFrame: Day 0, Week 4, Week 12
measure: Inflammation marker matrix metalloproteinase 9 (MMP9)
timeFrame: Day 0, Week 4, Week 12
measure: Lid-parallel conjunctival fold (LIPCOF) grading
timeFrame: Day 0, Week 4, Week 12
measure: Corneal staining
timeFrame: Day 0, Week 4, Week 12
measure: Tear volume
timeFrame: Day 0, Week 4, Week 12
measure: Conjunctival staining
timeFrame: Day 0, Week 4, Week 12
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Praxis Dr. Kaercher
state: Baden-Württemberg
city: Munich
country: Germany
facility: Praxis Prof. Dr. Anselm Kampik & Kollegen
state: Bavaria
city: Olching
country: Germany
facility: Augenzentrum Olching
state: Bavaria
city: Köln-Lindenthal
country: Germany
facility: Augenheilkunde Lindenthal
state: Nordrhein-Westfalen
city: Hamburg
country: Germany
facility: Dr. Flamm & Böker: Augenärzte am Tibarg
Study officials:
affiliation: Praxis Dr. Thomas Kaercher
name: Thomas Kaercher, Dr.
role: PRINCIPAL_INVESTIGATOR
References: