Effects of a Moisturizing Product on Dry Eye and Skin
Not Applicable
Completed
- Conditions
- Dry Eye Syndromes
- Interventions
- Device: Moisturizing Eye Product in Liquid Formula
- Registration Number
- NCT02683382
- Lead Sponsor
- Petra Larmo
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 52
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Moisturizing Eye Product, Comparison Moisturizing Eye Product in Liquid Formula 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. Moisturizing Eye Product (product in development) Moisturizing Eye Product in Liquid Formula 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.
- Primary Outcome Measures
Name Time Method 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 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 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 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 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 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
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Turun Silmäexpertit Oy
🇫🇮Turku, Finland