Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06596733

Vit-A-Vision® Clinical Investigation

Led by OmniVision GmbH · Updated on 2026-01-16

77

Participants Needed

1

Research Sites

45 weeks

Total Duration

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AI-Summary

What this Trial Is About

Symptoms of ocular discomfort include dryness, burning, stinging, photophobia, foreign body sensation and contact lens intolerance. These symptoms may affect basic daily activities, such as reading, driving, and working with computers. In case of moderate to severe conditions, dry eye disease is also associated with significant pain. Dry eye disease (DED) affects hundreds of millions of people throughout the world and is one of the most frequent causes of patient visits to eye care practitioners. Diagnosing, staging and determining the efficacy of therapy in DED is often challenging due to low correlation between signs and symptoms. Furthermore, its management is complicated because of its multifactorial aetiology. In general, management approaches begin with conventional, low-risk and easily accessible patient-applied therapies such as over-the-counter lubricants for early-stage disease, and progress to more advanced therapies for more severe forms of DED. In this regard, tear supplementation with ocular lubricants (artificial tears) is considered the first-line therapy and is often the only therapy used in mild to moderate disease. They are used in all stages of dry eye, either alone (in mild to moderate disease) or in combination with other treatments (in moderate to severe disease). Most tear supplements act as lubricants. Other actions may include replacement of deficient tear constituents, dilution of proinflammatory substances, reduction of tear osmolarity and protection against osmotic stress. A wide variety of artificial tear products is currently available. These products differ with respect to several variables, that include electrolyte composition, osmolarity/osmolality, viscosity, the presence or absence of preservatives and the presence or absence of compatible solutes. Although they are all considered as standard of care in treatment of dry eye disease, the effects of many of the available products have not been evaluated in clinical investigations. Vit-A-Vision is an ointment for ophthalmic application that relieves symptoms such as burning, irritation, slight irritation, dryness or tiredness of the eyes.

CONDITIONS

Official Title

Vit-A-Vision® Clinical Investigation

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • At least 18 years old
  • Ocular Surface Disease Index (OSDI) score of 16 or higher
  • Median of three consecutive non-invasive tear film break-up time (NIBUT) test results less than or equal to 10 seconds in at least one eye
  • Willingness to apply the medical device as directed during the entire study (about 33 days)
  • Willingness to attend follow-up visits at day 15 and day 33 after enrollment
  • Good understanding of the written and spoken languages used at the study center
Not Eligible

You will not qualify if you...

  • Known allergy to any ingredients of Vit-A-Vision (vaseline, paraffin, adeps lanae, vitamin A palmitate, dexpanthenol, alpha-Tocopherol acetate, or cetylstearyl alcohol)
  • Severe dry eye syndrome with OSDI greater than 55
  • Unwillingness to stop contact lens use during the study
  • Refractive surgery within the last 12 months or any other eye surgery or trauma within the last 4 months
  • Acute inflammatory or ocular surface diseases such as Sjögren's Syndrome, Stevens-Johnson Syndrome, ocular pemphigoid, or radiation-induced dry eye
  • Use of systemic medications affecting vision or dry eye, unless stable for over 3 months and unchanged during the study
  • Use of corticosteroids within 2 months before enrollment and during the study
  • Use of tetracyclines within 1 month before selection and during the study
  • Use of vitamin A supplements
  • Use of topical eye medications other than artificial tears within 2 weeks before the first visit
  • Use of topical cyclosporine within 3 months before the first visit
  • Use of eye drops or sprays based on liposomic or oily products during the study
  • Abnormal nasolacrimal drainage
  • Permanent occlusion of lacrimal puncta in any eye
  • Use of temporary punctal plugs within 2 months before selection
  • Previous participation in this study
  • Participation in another clinical trial within 30 days before selection
  • Children, pregnant or breastfeeding women
  • Under influence of excessive alcohol, narcotics, or benzodiazepines
  • Medical or psychological conditions that interfere with assessments or reliable treatment use
  • Individuals deprived of liberty by administrative or court order

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Dept. of Ophthalmology Cologne Merheim

Cologne, Germany, 51109

Actively Recruiting

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Research Team

J

Joachim Kolter

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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