Treatment of Dry Eye With Supplements
Recruitment status was Not yet recruiting
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.
|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|
- 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 ]
- 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 ]
|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)|
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
Please refer to this study by its ClinicalTrials.gov 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|
|Principal Investigator:||Doreen Schmidl, MD||Department of Clinical Pharmacology,Medical University of Vienna|