Treatment of Dry Eye With Supplements

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01364311
Recruitment Status : Withdrawn
First Posted : June 2, 2011
Last Update Posted : April 15, 2015
Information provided by:
Medical University of Vienna

May 25, 2011
June 2, 2011
April 15, 2015
July 2011
November 2014   (Final data collection date for primary outcome measure)
  • Improvement of subjective symptoms of dry eye syndrome [ Time Frame: 12 weeks ]
  • Break up time (BUT) [ Time Frame: 12 weeks ]
Same as current
Complete list of historical versions of study NCT01364311 on Archive Site
  • Visual Acuity [ Time Frame: 12 weeks ]
  • Tear film osmolarity [ Time Frame: 12 weeks ]
  • OSI (Objective Scattering Index) [ Time Frame: 12 weeks ]
  • Schirmer I test [ Time Frame: 12 weeks ]
  • Staining of the cornea with fluorescein [ Time Frame: 12 weeks ]
  • Impression cytology [ Time Frame: 12 weeks ]
  • Tear cytokines/chemokines [ Time Frame: 12 weeks ]
  • Data from patient diary how often Hylo-Comod® eye drops were used [ Time Frame: 12 weeks ]
Same as current
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Treatment of Dry Eye With Supplements
Treatment of Dry Eye With Supplements

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.

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Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Dry Eye Syndromes
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

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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
November 2014
November 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
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Not Provided
Gerhard Garhofer, MD, Ass.-Prof., Department of Clinical Pharmacology, Medical University of Vienna
Medical University of Vienna
Not Provided
Principal Investigator: Doreen Schmidl, MD Department of Clinical Pharmacology,Medical University of Vienna
Medical University of Vienna
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP