Effects of a Moisturizing Product on Dry Eye and Skin

NCT ID: NCT02683382

Last Updated: 2016-10-12

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

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2016-07-31

Brief Summary

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Dry eye is a common syndrome associated with symptoms of dryness, burning, itching and grittiness of eyes. The objective of this study is to investigate the effects of a moisturizing product in liquid formula on symptoms and signs of dry eye and on skin around the eyes.

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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Moisturizing Eye Product (product in development)

Moisturizing eye product in liquid form (medical device product in development). Part 1 of the study: Administered to both eyes 4 times/day for 1 day. Part 2: to one eye 4 times/day for 9 days. Part 3: to one eye 4 times/day for 45 days. Parts 2 \& 3: treatment eyes randomized.

Group Type EXPERIMENTAL

Moisturizing Eye Product in Liquid Formula

Intervention Type DEVICE

Moisturizing Eye Product in Liquid Formula for dry eyes and skin around the eyes

Moisturizing Eye Product, Comparison

Moisturizing eye product in liquid form (medical device CE-marked). Part 2 of the study: Administered to one eye 4 times/day for 9 days. Treatment eyes randomized.

Group Type ACTIVE_COMPARATOR

Moisturizing Eye Product in Liquid Formula

Intervention Type DEVICE

Moisturizing Eye Product in Liquid Formula for dry eyes and skin around the eyes

No treatment

Part 3 of the study: other eye is a control eye with no treatment for 45 days.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Moisturizing Eye Product in Liquid Formula

Moisturizing Eye Product in Liquid Formula for dry eyes and skin around the eyes

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Dry eye symptoms OSDI score 20 or higher
* Dryness, burning or foreign body sensation moderate or higher

Exclusion Criteria

* Severe eye diseases
* Known allergy to any of the ingredients of the product
* Laser surgery of eyes during the last year
Minimum Eligible Age

25 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Turun Silmäexpertit Oy, Turku, Finland

UNKNOWN

Sponsor Role collaborator

Tekes - The Finnish Funding Agency for Technology and Innovation

UNKNOWN

Sponsor Role collaborator

Finnsusp Oy, Lieto, Finland

UNKNOWN

Sponsor Role collaborator

Petra Larmo

INDUSTRY

Sponsor Role lead

Responsible Party

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Petra Larmo

Ph.D., R&D Manager

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Minna Sandberg-Lall, MD

Role: PRINCIPAL_INVESTIGATOR

Turun Silmäexpertit Oy, Turku, Finland

Locations

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Turun Silmäexpertit Oy

Turku, , Finland

Site Status

Countries

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Finland

Other Identifiers

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SDE

Identifier Type: -

Identifier Source: org_study_id

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