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Treatment of Dry Eye With Supplements

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ClinicalTrials.gov Identifier: NCT01364311
Recruitment Status : Withdrawn
First Posted : June 2, 2011
Last Update Posted : April 15, 2015
Sponsor:
Information provided by:
Medical University of Vienna

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

Resource links provided by the National Library of Medicine


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, Older Adult)
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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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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    Key Record Dates
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