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

T

TRB Chemedica

Status

Completed

Conditions

Dry Eye Syndromes

Treatments

Device: Povidone
Device: REMOGEN OMEGA

Study type

Interventional

Funder types

Industry

Identifiers

NCT02908282
REMODES-DE-2015-12

Details and patient eligibility

About

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

Enrollment

81 patients

Sex

All

Ages

18 to 81 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

81 participants in 2 patient groups

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

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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