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

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ClinicalTrials.gov Identifier: NCT02908282
Recruitment Status : Completed
First Posted : September 20, 2016
Last Update Posted : August 15, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Dry Eye Syndromes Device: REMOGEN OMEGA Device: Povidone Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 81 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : October 2016
Actual Primary Completion Date : July 2018
Actual Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Povidone

Arm Intervention/treatment
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.

C (control)-group
Povidone: Usage according to instructions for use.
Device: Povidone
Artificial tears: preservative-free eye drops containing 2% povidone.




Primary Outcome Measures :
  1. Ocular Surface Disease Index (OSDI©) questionnaire [ Time Frame: Week 4 ]
  2. Tear film stability [ Time Frame: Week 4 ]
    Tear film breakup time (unit: seconds)


Secondary Outcome Measures :
  1. OSDI questionnaire [ Time Frame: Day 0, Week 12 ]
  2. Tear film stability [ Time Frame: Day 0, Week 12 ]
    Tear film breakup time (unit: seconds)

  3. Visual acuity (best corrected) [ Time Frame: Day 0, Week 4, Week 12 ]
  4. TearLab osmolarity test [ Time Frame: Day 0, Week 4, Week 12 ]
  5. Inflammation marker matrix metalloproteinase 9 (MMP9) [ Time Frame: Day 0, Week 4, Week 12 ]
  6. Lid-parallel conjunctival fold (LIPCOF) grading [ Time Frame: Day 0, Week 4, Week 12 ]
  7. Corneal staining [ Time Frame: Day 0, Week 4, Week 12 ]
    Oxford grading scale

  8. Tear volume [ Time Frame: Day 0, Week 4, Week 12 ]
    Schirmer test

  9. Conjunctival staining [ Time Frame: Day 0, Week 4, Week 12 ]
    Oxford grading scale



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Ages Eligible for Study:   18 Years to 81 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02908282


Locations
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Germany
Praxis Dr. Kaercher
Heidelberg, Baden-Württemberg, Germany, 69121
Praxis Prof. Dr. Anselm Kampik & Kollegen
Munich, Bavaria, Germany, 80333
Augenzentrum Olching
Olching, Bavaria, Germany, 82140
Augenheilkunde Lindenthal
Köln-Lindenthal, Nordrhein-Westfalen, Germany, 50931
Dr. Flamm & Böker: Augenärzte am Tibarg
Hamburg, Germany, 22459
Sponsors and Collaborators
TRB Chemedica AG
Investigators
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Principal Investigator: Thomas Kaercher, Dr. Praxis Dr. Thomas Kaercher
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Responsible Party: TRB Chemedica AG
ClinicalTrials.gov Identifier: NCT02908282    
Other Study ID Numbers: REMODES-DE-2015-12
First Posted: September 20, 2016    Key Record Dates
Last Update Posted: August 15, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by TRB Chemedica AG:
tear film
omega-3 fatty acids
eye drops
Additional relevant MeSH terms:
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Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Povidone
Plasma Substitutes
Blood Substitutes