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Dry Eye OmniLenz Application of Omnigen Research Study

Launched by ASTON UNIVERSITY · Sep 11, 2020

Trial Information

Current as of July 21, 2025

Completed

Keywords

Dry Eye Disease Amniotic Membrane Bandage Contact Lenses Symptoms Tear Film Stability Ocular Surface Damage

ClinConnect Summary

The TFOS DEWS II report redefines dry eye as:

". . . a multifactorial disease of the ocular surface characterised by a loss of homeostasis of the tear film, and accompanied by ocular symptoms, in which tear film instability and hyperosmolarity, ocular surface inflammation and damage, and neurosensory abnormalities play etiological roles." Dry eye disease (DED) is a global problem, afflicting at least 344 million people worldwide, and is one of the most frequent causes of patient visits to eye care practitioners. However, the epidemiology of DED continues to be a challenge due to the lack o...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • A mean average score of 25 to 80 using more than one OSDI assessment in the last six weeks
  • DED present for at least 12 months
  • Informed consent
  • Aged 18 or over on date of Baseline assessment
  • Able to Attend Aston University
  • No changes to current DED therapy in the last six weeks
  • Presence of at least 1 of the following signs in the same eye at baseline visits
  • Corneal (≥5 punctate spots)
  • Conjunctival (≥9 punctate spots) staining present (Oxford scale)
  • Tear film break-up time (TBUT) less than or equal to 8 seconds
  • Received study information and expressed willingness to take part in this study
  • Confirmed able to attend the assessment visits described in the patient information
  • Able and willing to complete the patient information diaries
  • Exclusion Criteria:
  • Taking medication (except dry eye treatments) that is known to affect the tear film
  • Currently using moisture chamber or goggles
  • Active ocular surface pathology other than dry eye
  • Ocular topography that in the clinician opinion would make OmniLenz BCL treatment inappropriate
  • Allergic to ingredients within Omnigen (i.e. the antibiotics)
  • * History of:
  • Ocular herpetic keratitis
  • Ocular surgery in past 6 months
  • Use of glaucoma medicine
  • Surgery for glaucoma
  • Eyelid abnormalities or extensive ocular scarring

About Aston University

Aston University is a leading research institution based in Birmingham, UK, renowned for its commitment to advancing knowledge and innovation across various disciplines, including health sciences. As a clinical trial sponsor, Aston University leverages its strong academic foundation and interdisciplinary expertise to conduct rigorous and ethical research aimed at improving patient outcomes and healthcare practices. The university fosters collaboration with healthcare professionals, industry partners, and regulatory bodies to ensure that its clinical trials adhere to the highest standards of scientific integrity and compliance, ultimately contributing to the advancement of medical science and public health.

Locations

Birmingham, West Midlands, United Kingdom

Patients applied

0 patients applied

Trial Officials

Andrew Hopkinson, PhD

Study Director

NuVision

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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