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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2018-07-31

Brief Summary

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

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Detailed Description

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Conditions

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Dry Eye Syndromes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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PUFA (polyunsaturated fatty acids)-group

REMOGEN OMEGA: Usage according to instructions for use.

Group Type OTHER

REMOGEN OMEGA

Intervention Type DEVICE

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.

Group Type OTHER

Povidone

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type DEVICE

Povidone

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

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

81 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No