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

A

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

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.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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