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Completed

NCT Number: NCT02683382

Effects of a Moisturizing Product on Dry Eye and Skin

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.

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Key information

Conditions

Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

25 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Turun Silmäexpertit Oy

Turku, Finland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Moisturizing Eye Product in Liquid Formula

Device

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

Primary outcomes

  1. Change in symptoms of dry eye: Ocular Surface Disease Index (OSDI), scores of dryness, burning and foreign body sensation of eyes

    Time frame: Part 1: baseline, 2, 4, and 6 hours. Part 2: baseline, 1 day, 3 and 9 days. Part 3: baseline and 45 days

  2. Change in tear film osmolarity (mOsm/L)

    Time frame: Part 1: baseline, 2, 4, and 6 hours. Part 2: baseline, 1 day, 3 and 9 days. Part 3: baseline and 45 days

  3. Change in tear film break-up time (s)

    Time frame: Part 1: baseline, 2, 4, and 6 hours. Part 2: baseline, 1 day, 3 and 9 days. Part 3: baseline and 45 days

  4. Change in tear secretion, Schirmer test (mm/min)

    Time frame: Part 1: baseline, 2, 4, and 6 hours. Part 2: baseline, 1 day, 3 and 9 days. Part 3: baseline and 45 days

  5. Change in signs of irritation of eyes, scoring by an eye specialist

    Time frame: Part 1: baseline, 2, 4, and 6 hours. Part 2: baseline, 1 day, 3 and 9 days. Part 3: baseline and 45 days

  6. Change in transepidermal water loss from skin around the eyes (g/m2h)

    Time frame: Part 1: baseline, 2, 4, and 6 hours. Part 2: baseline, 1 day, 3 and 9 days. Part 3: baseline and 45 days

Secondary outcomes

  1. 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)

    Time frame: Part 2: change from baseline to 9 days; Part 3: change from baseline to 45 days

Sponsors and collaborators

Lead sponsor

Petra Larmo

Industry

Collaborators

  • Finnsusp Oy, Lieto, Finland
  • The Finnish Funding Agency for Technology and Innovation
  • Turun Silmäexpertit Oy, Turku, Finland

Registry information

Acronym: SDE

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Feb 17, 2016
Registry last updated
Oct 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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