NCT02908282

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2016

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 20, 2016

Completed
11 days until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

August 15, 2018

Status Verified

August 1, 2018

Enrollment Period

1.7 years

First QC Date

September 13, 2016

Last Update Submit

August 14, 2018

Conditions

Dry Eye Syndromes

Keywords

tear filmomega-3 fatty acidseye drops

Outcome Measures

Primary Outcomes (2)

  • Ocular Surface Disease Index (OSDI©) questionnaire

    Week 4

  • Tear film stability

    Tear film breakup time (unit: seconds)

    Week 4

Secondary Outcomes (9)

  • OSDI questionnaire

    Day 0, Week 12

  • Tear film stability

    Day 0, Week 12

  • Visual acuity (best corrected)

    Day 0, Week 4, Week 12

  • TearLab osmolarity test

    Day 0, Week 4, Week 12

  • Inflammation marker matrix metalloproteinase 9 (MMP9)

    Day 0, Week 4, Week 12

  • +4 more secondary outcomes

Study Arms (2)

PUFA (polyunsaturated fatty acids)-group

OTHER

REMOGEN OMEGA: Usage according to instructions for use.

Device: REMOGEN OMEGA

C (control)-group

OTHER

Povidone: Usage according to instructions for use.

Device: Povidone

Interventions

REMOGEN OMEGADEVICE

Lubricant eye drops: preservative-free, hypotonic microemulsion of polyunsaturated fatty acids and hydrating polymers provided in single-dose containers of 0.25 ml.

PUFA (polyunsaturated fatty acids)-group
PovidoneDEVICE

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

C (control)-group

Eligibility Criteria

Age18 Years - 81 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Praxis Dr. Kaercher

Heidelberg, Baden-Wurttemberg, 69121, Germany

Location

Praxis Prof. Dr. Anselm Kampik & Kollegen

Munich, Bavaria, 80333, Germany

Location

Augenzentrum Olching

Olching, Bavaria, 82140, Germany

Location

Augenheilkunde Lindenthal

Köln-Lindenthal, North Rhine-Westphalia, 50931, Germany

Location

Dr. Flamm & Böker: Augenärzte am Tibarg

Hamburg, 22459, Germany

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Officials

  • Thomas Kaercher, Dr.

    Praxis Dr. Thomas Kaercher

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2016

First Posted

September 20, 2016

Study Start

October 1, 2016

Primary Completion

July 1, 2018

Study Completion

July 1, 2018

Last Updated

August 15, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

DE(5)