Effects of a Moisturizing Product on Dry Eye and Skin

Study Overview
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Brief Summary
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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.

Conditions
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Dry Eye Syndromes

Intervention / Treatment
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* Device: Moisturizing Eye Product in Liquid Formula


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Moisturizing Eye Product (product in development)<br>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<br>* Moisturizing Eye Product in Liquid Formula for dry eyes and skin around the eyes<br>|
| Active Comparator: Moisturizing Eye Product, Comparison<br>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<br>* Moisturizing Eye Product in Liquid Formula for dry eyes and skin around the eyes<br>|
| No Intervention: No treatment<br>Part 3 of the study: other eye is a control eye with no treatment for 45 days. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 |