Treatment of Dry Eye With Supplements

Dry Eye Syndromes Clinical Trial

Official title:

Treatment of Dry Eye With Supplements

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01364311
• Other study ID #: OPHT-120111
• Status: Withdrawn
• Phase: N/A
• First received: May 25, 2011
• Last updated: April 14, 2015
• Start date: July 2011
• Est. completion date: November 2014

Study information

• Verified date: November 2014
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food Safety
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

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

Locations

Country	Name	City	State
Austria	Department of Clinical Pharmacology, Medical University Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of subjective symptoms of dry eye syndrome		12 weeks	No
Primary	Break up time (BUT)		12 weeks	No
Secondary	Visual Acuity		12 weeks	No
Secondary	Tear film osmolarity		12 weeks	No
Secondary	OSI (Objective Scattering Index)		12 weeks	No
Secondary	Schirmer I test		12 weeks	No
Secondary	Staining of the cornea with fluorescein		12 weeks	No
Secondary	Impression cytology		12 weeks	No
Secondary	Tear cytokines/chemokines		12 weeks	No
Secondary	Data from patient diary how often Hylo-Comod® eye drops were used		12 weeks	No