Effects of a Moisturizing Product on Dry Eye and Skin

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02683382

Acronym

SDE

Enrollment

Registered

2016-02-17

Start date

2016-03-31

Completion date

2016-07-31

Last updated

2016-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Eye Syndromes

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.

Interventions

DEVICEMoisturizing Eye Product in Liquid Formula

Moisturizing Eye Product in Liquid Formula for dry eyes and skin around the eyes

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

25 Years to 70 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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 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 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 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

Secondary

Measure	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

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026