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Effects of a Moisturizing Product on Dry Eye and Skin (SDE)

Primary Purpose

Dry Eye Syndromes

Status

Completed

Phase

Not Applicable

Locations

Finland

Study Type

Interventional

Intervention

Moisturizing Eye Product in Liquid Formula

About this trial

This is an interventional treatment trial for Dry Eye Syndromes

Eligibility Criteria

25 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Turun Silmäexpertit Oy

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Moisturizing Eye Product (product in development)

Moisturizing Eye Product, Comparison

No treatment

Arm Description

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.

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.

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

Outcomes

Primary Outcome Measures

Change in symptoms of dry eye: Ocular Surface Disease Index (OSDI), scores of dryness, burning and foreign body sensation of eyes

Change in tear film osmolarity (mOsm/L)

Change in tear film break-up time (s)

Change in tear secretion, Schirmer test (mm/min)

Change in signs of irritation of eyes, scoring by an eye specialist

Change in transepidermal water loss from skin around the eyes (g/m2h)

Secondary Outcome Measures

Change in other symptoms of dry eye: soreness, grittiness, watery eyes, redness, blurring of eyes (daily symptom logbooks: scoring in scale from 0 to 3)

Full Information

NCT ID

NCT02683382

First Posted

February 2, 2016

Last Updated

October 11, 2016

Sponsor

Petra Larmo

Collaborators

Turun Silmäexpertit Oy, Turku, Finland, Tekes - The Finnish Funding Agency for Technology and Innovation, Finnsusp Oy, Lieto, Finland

1. Study Identification

Unique Protocol Identification Number

NCT02683382

Brief Title

Effects of a Moisturizing Product on Dry Eye and Skin

Acronym

SDE

Study Type

Interventional

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Completed

Study Start Date

March 2016 (undefined)

Primary Completion Date

June 2016 (Actual)

Study Completion Date

July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Petra Larmo

Collaborators

Turun Silmäexpertit Oy, Turku, Finland, Tekes - The Finnish Funding Agency for Technology and Innovation, Finnsusp Oy, Lieto, Finland

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dry Eye Syndromes

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

52 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Moisturizing Eye Product (product in development)

Arm Type

Experimental

Arm Description

Arm Title

Moisturizing Eye Product, Comparison

Arm Type

Active Comparator

Arm Description

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.

Arm Title

No treatment

Arm Type

No Intervention

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Moisturizing Eye Product in Liquid Formula

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in symptoms of dry eye: Ocular Surface Disease Index (OSDI), scores of dryness, burning and foreign body sensation of eyes

Time Frame