This trial is active, not recruiting.

Condition dry eye syndromes
Treatments sea buckthorn (hippophaë rhamnoides) oil, placebo comparison
Sponsor University of Turku
Collaborator Turku Municipal Health Department/evo-funding
Start date September 2008
End date March 2009
Trial size 80 participants
Trial identifier NCT00739713, DESB


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Sea buckthorn oil group
sea buckthorn (hippophaë rhamnoides) oil
Dosage 2 g/d, frequency twice/d, duration 3 months
(Placebo Comparator)
Placebo group
placebo comparison
Placebo comparison, dosage 2 g/d, frequency twice/d, duration 3 months

Primary Outcomes

Symptom severity: symptom questionnaires and clinical dry eye tests
time frame: 3 months intervention + 1 month after the intervention

Secondary Outcomes

Tear film lipid profile, tear cytokines, inflammation mediators in blood
time frame: 3 months intervention + 1 month after the intervention

Eligibility Criteria

Male or female participants from 20 years up to 75 years old.

Inclusion Criteria: - Dry eye symptoms Exclusion Criteria: - Severe illness - Anticholinergic drugs - Smoking

Additional Information

Official title Effects of Sea Buckthorn Oil on Dry Eye
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2010.
Information provided to ClinicalTrials.gov by University of Turku.