Treatment of Dry Eye With Supplements

Sponsor

Medical University of Vienna (Other)

Overall Status

Withdrawn

CT.gov ID

NCT01364311

Collaborator

(none)

Enrollment

Location

Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Syndromes	Dietary Supplement: Vitamac® Tag and Nacht capsules	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Basic Science

Official Title:

Treatment of Dry Eye With Supplements

Study Start Date :

Jul 1, 2011

Actual Primary Completion Date :

Nov 1, 2014

Actual Study Completion Date :

Nov 1, 2014

Outcome Measures

Primary Outcome Measures

Improvement of subjective symptoms of dry eye syndrome [12 weeks]
Break up time (BUT) [12 weeks]

Secondary Outcome Measures

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]
Impression cytology [12 weeks]
Tear cytokines/chemokines [12 weeks]
Data from patient diary how often Hylo-Comod® eye drops were used [12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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