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Completed

NCT Number: NCT00739713

Effects of Sea Buckthorn Oil on Dry Eye

The objective is to study the effect of sea buckthorn oil on dry eye.

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Key information

Conditions

Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Turku

Turku, 20014, Finland

About this study

The objective is to study whether regular consumption of sea buckthorn berry oil can relieve the symptoms of dry eye syndrome. The study design is a parallel randomized double-blind placebo controlled trial. The participants daily consume sea buckthorn or placebo oil for 3 months. The dry eye symptoms will be monitored during the study using a validated questionnaire. In addition clinical dry eye tests are made by an ophthalmologist three time during the study. Samples will be taken for tear film lipid and cytokine analyses. Blood samples for the analyses of inflammatory markers are also obtained. The cytokine and other inflammation marker analyses are optional. The symptoms will be monitored and clinical tests made also 4 weeks after the participants have stopped consuming the study oils.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Dry eye symptoms

Exclusion criteria

  • Severe illness
  • Anticholinergic drugs
  • Smoking

Treatment and study plan

Sea buckthorn (Hippophaë rhamnoides) oil

Dietary Supplement

Dosage 2 g/d, frequency twice/d, duration 3 months

Placebo comparison

Dietary Supplement

Placebo comparison, dosage 2 g/d, frequency twice/d, duration 3 months

Primary outcomes

  1. Symptom severity: symptom questionnaires and clinical dry eye tests

    Time frame: 3 months intervention + 1 month after the intervention

Secondary outcomes

  1. Tear film lipid profile, tear cytokines, inflammation mediators in blood

    Time frame: 3 months intervention + 1 month after the intervention

Sponsors and collaborators

Lead sponsor

University of Turku

Other

Collaborators

  • Aromtech Ltd.
  • Finnsusp Ltd.
  • Shiny Horse Ltd
  • The Finnish Funding Agency for Technology and Innovation
  • Turku Municipal Health Department/evo-funding
  • Turku University Hospital
  • Valioravinto Ltd

Registry information

Acronym: DESB

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Aug 22, 2008
Registry last updated
Mar 20, 2018

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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