Treatment of Dry Eye With Supplements - Full Text View

Purpose

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	Intervention
Dry Eye Syndromes	Dietary Supplement: Vitamac® Tag and Nacht capsules


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Basic Science
Official Title:	Treatment of Dry Eye With Supplements

Resource links provided by NLM:

Genetics Home Reference related topics: keratitis-ichthyosis-deafness syndrome

MedlinePlus related topics: Dietary Supplements Tears

U.S. FDA Resources

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:

Improvement of subjective symptoms of dry eye syndrome [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Break up time (BUT) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Visual Acuity [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Tear film osmolarity [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
OSI (Objective Scattering Index) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Schirmer I test [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Staining of the cornea with fluorescein [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Impression cytology [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Tear cytokines/chemokines [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Data from patient diary how often Hylo-Comod® eye drops were used [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]


Enrollment:	0
Study Start Date:	July 2011
Study Completion Date:	November 2014
Primary Completion Date:	November 2014 (Final data collection date for primary outcome measure)

Intervention Details:

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

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01364311

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


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
Study First Received:	May 25, 2011
Last Updated:	April 14, 2015
Health Authority:	Austria: Agency for Health and Food Safety

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

ClinicalTrials.gov processed this record on September 27, 2016