Treatment of Dry Eye With Supplements

Study Overview
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Brief Summary
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Dry eye syndrome (DES) is a highly prevalent ocular condition inducing an inflammatory response on the ocular surface. Common symptoms include ocular discomfort, visual impairment and instability of the tear film with potential damage to the ocular surface. In addition, an intact tear film is important to provide a smooth optical surface, to act as a barrier to pathogens, to nourish the epithelial cells of the ocular surface and to prevent exsiccation. Alterations in the tear film composition, which can have their origin in several conditions, lead to tear film hyperosmolarity or instability resulting in DES. Regardless of the cause of DES, chronic dryness of the ocular surface leads to an increased susceptibility to oxidative stress, which is triggered by reactive oxygen species (ROS). This results in cell damage and activation of the immune system, keeping up inflammatory processes . In order to prevent ROS damage, several micronutrients such as vitamin C, E, and certain carotenoids, omega-3 free fatty acids, flavonoids and minerals have been used because of their antioxidant capacities. Based on this knowledge the potential of these antioxidant dietary supplements has been discussed as a treatment option for DES. Preliminary data support the hypothesis that antioxidant supplementations, in particular, supplementation with omega 3 fatty acids may be beneficial for patients with DES. The purpose of the present study is to test the hypothesis that treatment with dietary supplements improves subjective and objective symptoms of DES.

Official Title
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Treatment of Dry Eye With Supplements

Conditions
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Dry Eye Syndromes

Intervention / Treatment
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* Dietary Supplement: Vitamac® Tag and Nacht capsules


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women aged over 18 years History of dry eye syndrome for at least 3 months Tear Break Up Time (BUT) < 10 seconds or Schirmer I test < 7 mm At least 2 symptoms of dry eye syndrome (foreign body sensation, burning, photophobia, blurred vision, pain, itching) -Normal ophthalmic findings except dry eye syndrome Exclusion Criteria: Participation in a clinical trial in the 3 weeks preceding the study Symptoms of a clinically relevant illness in the 3 weeks before the first study day Presence or history of a severe medical condition that will interfere with the study aim as judged by the clinical investigator Wearing of contact lenses Intake of dietary supplements in the 3 months preceding the study Glaucoma Treatment with corticosteroids in the 4 weeks preceding the study Topical treatment with any ophthalmic drug except topical lubricants in the 4 weeks preceding the study Ocular infection or inflammation Ocular surgery in the 3 months preceding the study Sjögren's syndrome Stevens-Johnson syndrome Pregnancy, planned pregnancy or lactating

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Dietary Supplement: Vitamac® Tag and Nacht capsules|Vitamac® Tag und Nacht Kapseln: Dosage 1 capsule Vitamac® Tag per day ingested in the morning, 1 capsule Vitamac® Nacht per day ingested in the evening. Vitamac® Tag: Lutein 12mg, Vitamin C 300mg, Zinc 10mg, ginkgo biloba 10mg, Flavinoids 25mg, Fishoil 300mg, administered for 12 weeks Vitamac® Nacht: Zeaxanthin 5mg, Vitamin E 60mg, Copper 1mg, Selen 20µg, Ginkgo Biloba 10mg, Flavinoids 25mg, Alpha Lipon acid 150mg), administered for 12 weeks|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of subjective symptoms of dry eye syndrome |  | 12 weeks | 
| Break up time (BUT) |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Acuity |  | 12 weeks | 
| Tear film osmolarity |  | 12 weeks | 
| OSI (Objective Scattering Index) |  | 12 weeks | 
| Schirmer I test |  | 12 weeks | 
| Staining of the cornea with fluorescein |  | 12 weeks | 
| Impression cytology |  | 12 weeks | 
| Tear cytokines/chemokines |  | 12 weeks | 
| Data from patient diary how often Hylo-Comod® eye drops were used |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dry Eye Syndromes, Dietary Supplements, Vitamac® Tag and Nacht capsules, Lutein, Vitamin C, Zinc, ginkgo biloba, Flavinoids, Fishoil, Zeaxanthin, Vitamin E, Copper, Selen, Alpha Lipon acid, Break up time (BUT), Improvement of subjective symptoms of dry eye syndrome, Visual Acuity, Tear film osmolarity, OSI (Objective Scattering Index), Schirmer I test, Staining of the cornea with fluorescein, Impression cytology, Tear cytokines/chemokines, Data from patient diary how often Hylo-Comod® eye drops were used