Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02683382
Recruitment Status : Completed
First Posted : February 17, 2016
Last Update Posted : October 12, 2016
Sponsor:
Collaborators:
Turun Silmäexpertit Oy, Turku, Finland
Tekes - The Finnish Funding Agency for Technology and Innovation
Finnsusp Oy, Lieto, Finland
Information provided by (Responsible Party):
Petra Larmo, Aromtech Ltd.

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.

Condition or disease Intervention/treatment Phase
Dry Eye Syndromes Device: Moisturizing Eye Product in Liquid Formula Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : March 2016
Actual Primary Completion Date : June 2016
Actual Study Completion Date : July 2016

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.



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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   25 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02683382


Locations
Layout table for location information
Finland
Turun Silmäexpertit Oy
Turku, Finland
Sponsors and Collaborators
Petra Larmo
Turun Silmäexpertit Oy, Turku, Finland
Tekes - The Finnish Funding Agency for Technology and Innovation
Finnsusp Oy, Lieto, Finland
Investigators
Layout table for investigator information
Principal Investigator: Minna Sandberg-Lall, MD Turun Silmäexpertit Oy, Turku, Finland
Layout table for additonal information
Responsible Party: Petra Larmo, Ph.D., R&D Manager, Aromtech Ltd.
ClinicalTrials.gov Identifier: NCT02683382    
Other Study ID Numbers: SDE
First Posted: February 17, 2016    Key Record Dates
Last Update Posted: October 12, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases