Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Treatment of Dry Eye With Supplements

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Medical University of Vienna.
Recruitment status was  Not yet recruiting
Information provided by:
Medical University of Vienna Identifier:
First received: May 25, 2011
Last updated: June 17, 2011
Last verified: May 2011

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:

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 ]

Estimated Enrollment: 50
Study Start Date: July 2011
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
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


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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 identifier: NCT01364311

Contact: Gerhard Garhöfer, MD +43 1 40400 ext 2981

Department of Clinical Pharmacology, Medical University Vienna Not yet recruiting
Vienna, Austria, 1090
Contact: Doreen Schmidl, MD    + 43 1 40400 ext 2988      
Sponsors and Collaborators
Medical University of Vienna
Principal Investigator: Doreen Schmidl, MD Department of Clinical Pharmacology,Medical University of Vienna
  More Information

No publications provided

Responsible Party: Gerhard Garhofer, MD, Ass.-Prof., Department of Clinical Pharmacology, Medical University of Vienna Identifier: NCT01364311     History of Changes
Other Study ID Numbers: OPHT-120111
Study First Received: May 25, 2011
Last Updated: June 17, 2011
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
Vitamin C
ginkgo biloba
Vitamin E
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:
Dry Eye Syndromes
Keratoconjunctivitis Sicca
Conjunctival Diseases
Corneal Diseases
Eye Diseases
Lacrimal Apparatus Diseases processed this record on March 01, 2015