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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
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01364311
First received: May 25, 2011
Last updated: June 17, 2011
Last verified: May 2011

May 25, 2011
June 17, 2011
July 2011
July 2012   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01364311 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
50
November 2012
July 2012   (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
Both
18 Years and older
Yes
Contact: Gerhard Garhöfer, MD +43 1 40400 ext 2981
Austria
 
NCT01364311
OPHT-120111
Yes
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
May 2011

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