Clinical trial NCT01364311: Treatment of Dry Eye With Supplements
Official title: Treatment of Dry Eye With Supplements
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
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
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2011-06-02
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: Improvement of subjective symptoms of dry eye syndrome
timeFrame: 12 weeks
measure: Break up time (BUT)
timeFrame: 12 weeks
Secondary outcomes:
measure: Visual Acuity
timeFrame: 12 weeks
measure: Tear film osmolarity
timeFrame: 12 weeks
measure: OSI (Objective Scattering Index)
timeFrame: 12 weeks
measure: Schirmer I test
timeFrame: 12 weeks
measure: Staining of the cornea with fluorescein
timeFrame: 12 weeks
measure: Impression cytology
timeFrame: 12 weeks
measure: Tear cytokines/chemokines
timeFrame: 12 weeks
measure: Data from patient diary how often Hylo-Comod® eye drops were used
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Department of Clinical Pharmacology, Medical University Vienna
Study officials:
affiliation: Department of Clinical Pharmacology,Medical University of Vienna
name: Doreen Schmidl, MD
role: PRINCIPAL_INVESTIGATOR
References: