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Effects of Sea Buckthorn Oil on Dry Eye (DESB)

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ClinicalTrials.gov Identifier: NCT00739713
Recruitment Status : Completed
First Posted : August 22, 2008
Last Update Posted : March 20, 2018
Sponsor:
Collaborators:
Turku Municipal Health Department/evo-funding
Turku University Hospital
Finnsusp Ltd.
Aromtech Ltd.
Shiny Horse Ltd
Valioravinto Ltd
The Finnish Funding Agency for Technology and Innovation (TEKES)
Information provided by:
University of Turku

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The objective is to study the effect of sea buckthorn oil on dry eye.

Condition or disease Intervention/treatment Phase
Dry Eye Syndromes Dietary Supplement: Sea buckthorn (Hippophaë rhamnoides) oil Dietary Supplement: Placebo comparison Not Applicable

Detailed Description:
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.

Study Design
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Sea Buckthorn Oil on Dry Eye
Actual Study Start Date : September 2008
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Care
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: SB
Sea buckthorn oil group
 Dietary Supplement: Sea buckthorn (Hippophaë rhamnoides) oil
Dosage 2 g/d, frequency twice/d, duration 3 months
Placebo Comparator: PL
Placebo group
 Dietary Supplement: Placebo comparison
Placebo comparison, dosage 2 g/d, frequency twice/d, duration 3 months


Outcome Measures
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Symptom severity: symptom questionnaires and clinical dry eye tests [ Time Frame: 3 months intervention + 1 month after the intervention ]

Secondary Outcome Measures :
  1. Tear film lipid profile, tear cytokines, inflammation mediators in blood [ Time Frame: 3 months intervention + 1 month after the intervention ]

Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Dry eye symptoms

Exclusion Criteria:

  • Severe illness
  • Anticholinergic drugs
  • Smoking
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00739713


Locations
Finland
University of Turku
Turku, Finland, 20014
Sponsors and Collaborators
University of Turku
Turku Municipal Health Department/evo-funding
Turku University Hospital
Finnsusp Ltd.
Aromtech Ltd.
Shiny Horse Ltd
Valioravinto Ltd
The Finnish Funding Agency for Technology and Innovation (TEKES)
Investigators
Study Director: Heikki P Kallio, Professor University of Turku
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

Other Publications:

Responsible Party: Matti Viitanen/ Professor, University of Turku
ClinicalTrials.gov Identifier: NCT00739713     History of Changes
Other Study ID Numbers: DESB
First Posted: August 22, 2008    Key Record Dates
Last Update Posted: March 20, 2018
Last Verified: March 2017

Keywords provided by University of Turku:
dry eye
sea buckthorn
Hippophaë

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
 Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases