Treatment of Dry Eye With Supplements

Study Description

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Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Dry Eye Syndromes	Dietary Supplement: Vitamac® Tag and Nacht capsules	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	0 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Basic Science
Official Title:	Treatment of Dry Eye With Supplements
Study Start Date :	July 2011
Actual Primary Completion Date :	November 2014
Actual Study Completion Date :	November 2014

Arms and Interventions

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Intervention Details:

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

Outcome Measures

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Primary Outcome Measures :

1. Improvement of subjective symptoms of dry eye syndrome [ Time Frame: 12 weeks ]
2. Break up time (BUT) [ Time Frame: 12 weeks ]

Secondary Outcome Measures :

1. Visual Acuity [ Time Frame: 12 weeks ]
2. Tear film osmolarity [ Time Frame: 12 weeks ]
3. OSI (Objective Scattering Index) [ Time Frame: 12 weeks ]
4. Schirmer I test [ Time Frame: 12 weeks ]
5. Staining of the cornea with fluorescein [ Time Frame: 12 weeks ]
6. Impression cytology [ Time Frame: 12 weeks ]
7. Tear cytokines/chemokines [ Time Frame: 12 weeks ]
8. Data from patient diary how often Hylo-Comod® eye drops were used [ Time Frame: 12 weeks ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

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

Locations

Austria
Department of Clinical Pharmacology, Medical University Vienna
Vienna, Austria, 1090

Sponsors and Collaborators

Medical University of Vienna

Investigators

Principal Investigator:	Doreen Schmidl, MD	Department of Clinical Pharmacology,Medical University of Vienna

More Information

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

Responsible Party:	Gerhard Garhofer, MD, Ass.-Prof., Department of Clinical Pharmacology, Medical University of Vienna
ClinicalTrials.gov Identifier:	NCT01364311 History of Changes
Other Study ID Numbers:	OPHT-120111
First Posted:	June 2, 2011
Last Update Posted:	April 15, 2015
Last Verified:	November 2014

Keywords provided by Medical University of Vienna:

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

Additional relevant MeSH terms:

Syndrome; Keratoconjunctivitis Sicca; Dry Eye Syndromes; Disease; Pathologic Processes; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases	Eye Diseases; Keratitis; Corneal Diseases; Lacrimal Apparatus Diseases; Vitamins; Micronutrients; Growth Substances; Physiological Effects of Drugs