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

Aromtech

Status: Completed

Conditions: Dry Eye Syndromes

Treatments: Device: Moisturizing Eye Product in Liquid Formula

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT02683382

SDE

Details and patient eligibility

About

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.

Enrollment: 52 patients

Sex: All

Ages: 25 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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52 participants in 3 patient groups

Moisturizing Eye Product (product in development)

Experimental group

Description:

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.

Treatment:

Device: Moisturizing Eye Product in Liquid Formula

Moisturizing Eye Product, Comparison

Active Comparator group

Description:

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.

Treatment:

Device: Moisturizing Eye Product in Liquid Formula

No treatment

No Intervention group

Description:

Part 3 of the study: other eye is a control eye with no treatment for 45 days.