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

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.

Study Overview

• Status: Completed
• Conditions: Dry Eye Syndromes
• Intervention / Treatment: Device: Moisturizing Eye Product in Liquid Formula

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Turku, Finland
    • Turun Silmäexpertit Oy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 23 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Moisturizing Eye Product in Liquid Formula; Moisturizing Eye Product in Liquid Formula for dry eyes and skin around the eyes
Active Comparator: 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.	Device: Moisturizing Eye Product in Liquid Formula; Moisturizing Eye Product in Liquid Formula for dry eyes and skin around the eyes
No Intervention: No treatment; Part 3 of the study: other eye is a control eye with no treatment for 45 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in symptoms of dry eye: Ocular Surface Disease Index (OSDI), scores of dryness, burning and foreign body sensation of eyes	Part 1: baseline, 2, 4, and 6 hours. Part 2: baseline, 1 day, 3 and 9 days. Part 3: baseline and 45 days
Change in tear film osmolarity (mOsm/L)	Part 1: baseline, 2, 4, and 6 hours. Part 2: baseline, 1 day, 3 and 9 days. Part 3: baseline and 45 days
Change in tear film break-up time (s)	Part 1: baseline, 2, 4, and 6 hours. Part 2: baseline, 1 day, 3 and 9 days. Part 3: baseline and 45 days
Change in tear secretion, Schirmer test (mm/min)	Part 1: baseline, 2, 4, and 6 hours. Part 2: baseline, 1 day, 3 and 9 days. Part 3: baseline and 45 days
Change in signs of irritation of eyes, scoring by an eye specialist	Part 1: baseline, 2, 4, and 6 hours. Part 2: baseline, 1 day, 3 and 9 days. Part 3: baseline and 45 days
Change in transepidermal water loss from skin around the eyes (g/m2h)	Part 1: baseline, 2, 4, and 6 hours. Part 2: baseline, 1 day, 3 and 9 days. Part 3: baseline and 45 days

Secondary Outcome Measures

Outcome Measure	Time Frame
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)	Part 2: change from baseline to 9 days; Part 3: change from baseline to 45 days

Collaborators and Investigators

• Sponsor: Petra Larmo
• Collaborators: Tekes - The Finnish Funding Agency for Technology and Innovation; Turun Silmäexpertit Oy, Turku, Finland; Finnsusp Oy, Lieto, Finland
• Investigators: Principal Investigator: Minna Sandberg-Lall, MD, Turun Silmäexpertit Oy, Turku, Finland

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: February 2, 2016
• First Submitted That Met QC Criteria: February 11, 2016
• First Posted (Estimate): February 17, 2016

Study Record Updates

• Last Update Posted (Estimate): October 12, 2016
• Last Update Submitted That Met QC Criteria: October 11, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca
• Other Study ID Numbers: SDE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No