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Treatment of Dry Eye With Supplements

Primary Purpose

Dry Eye Syndromes

Status

Withdrawn

Phase

Not Applicable

Locations

Austria

Study Type

Interventional

Intervention

Vitamac® Tag and Nacht capsules

About this trial

This is an interventional basic science trial for Dry Eye Syndromes focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Department of Clinical Pharmacology, Medical University Vienna

Outcomes

Primary Outcome Measures

Improvement of subjective symptoms of dry eye syndrome

Break up time (BUT)

Secondary Outcome Measures

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

Full Information

NCT ID

NCT01364311

First Posted

May 25, 2011

Last Updated

April 14, 2015

Sponsor

Medical University of Vienna

1. Study Identification

Unique Protocol Identification Number

NCT01364311

Brief Title

Treatment of Dry Eye With Supplements

Official Title

Treatment of Dry Eye With Supplements

Study Type

Interventional

2. Study Status

Record Verification Date

November 2014

Overall Recruitment Status

Withdrawn

Study Start Date

July 2011 (undefined)

Primary Completion Date

November 2014 (Actual)

Study Completion Date

November 2014 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Medical University of Vienna

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Dietary Supplement

Intervention Name(s)

Vitamac® Tag and Nacht capsules

Intervention Description

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

Primary Outcome Measure Information:

Title

Improvement of subjective symptoms of dry eye syndrome

Time Frame

12 weeks

Title

Break up time (BUT)

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Visual Acuity

Time Frame

12 weeks

Title

Tear film osmolarity

Time Frame

12 weeks

Title

OSI (Objective Scattering Index)

Time Frame

12 weeks

Title

Schirmer I test

Time Frame

12 weeks

Title

Staining of the cornea with fluorescein

Time Frame

12 weeks

Title

Impression cytology

Time Frame

12 weeks

Title

Tear cytokines/chemokines

Time Frame

12 weeks

Title

Data from patient diary how often Hylo-Comod® eye drops were used

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Doreen Schmidl, MD

Organizational Affiliation

Department of Clinical Pharmacology,Medical University of Vienna

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Clinical Pharmacology, Medical University Vienna

City

Vienna

ZIP/Postal Code

1090

Country

Austria

12. IPD Sharing Statement

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Treatment of Dry Eye With Supplements

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