Effects of a Moisturizing Product on Dry Eye and Skin

Dry Eye Syndromes Clinical Trial

— SDE  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02683382
• Other study ID #: SDE
• Status: Completed
• Phase: N/A
• First received: February 2, 2016
• Last updated: October 11, 2016
• Start date: March 2016
• Est. completion date: July 2016

Study information

• Verified date: October 2016
• Source: Aromtech Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Valvira - National Supervisory Authority for Welfare and Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: July 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

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

Locations

Country	Name	City	State
Finland	Turun Silmäexpertit Oy	Turku

Sponsors (4)

Lead Sponsor	Collaborator
Petra Larmo	Finnsusp Oy, Lieto, Finland, Tekes - The Finnish Funding Agency for Technology and Innovation, Turun Silmäexpertit Oy, Turku, Finland

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	Yes
Primary	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	Yes
Secondary	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	No