Treatment of Dry Eye With Supplements

NCT01364311 | Withdrawn DMC

• 1 other identifier: OPHT-120111
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry Eye Syndromes

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Improvement of subjective symptoms of dry eye syndrome

  12 weeks

• Break up time (BUT)

  12 weeks

Secondary Outcomes (8)

• Visual Acuity

  12 weeks

• Tear film osmolarity

  12 weeks

• OSI (Objective Scattering Index)

  12 weeks

• Schirmer I test

  12 weeks

• Staining of the cornea with fluorescein

  12 weeks

Interventions

Vitamac® Tag and Nacht capsules DIETARY_SUPPLEMENT

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Department of Clinical Pharmacology, Medical University Vienna

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Doreen Schmidl, MD

  Department of Clinical Pharmacology,Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 25, 2011
• First Posted: June 2, 2011
• Study Start: July 1, 2011
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: April 15, 2015

Record last verified: 2014-11

Locations

AU (1)