Dry Eye OmniLenz Application of Omnigen Research Study

NCT04553432 | Completed Phase 4

• 1 other identifier: Aston1612
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

Brief Summary

Dry eye disease (DED) is a disease of the ocular surface characterised by ocular surface inflammation and damage and neurosensory abnormalities. Tear film breakup leading to localised hyperosmolarity can result in ocular surface damage either directly or through the cascade of inflammation that it initiates. Transplantation of human amniotic membrane has been used for many ophthalmic indications including many related to inflammation of the ocular surface. A recent study published by McDonald and colleagues in 2018 conducted in 84 DED patients (97 eyes) receiving cryopreserved AM treatment (Prokera) in addition to prior maximal medical management demonstrated an improved ocular surface along with a notable reduction in disease severity scores. Omnigen is a dehydrated amniotic membrane derived from human sources and certified by the UK Human Tissue Authority. OmniLenz Bandage Contact Lens (BCL) is a bespoke bandage contact lens (BCL) designed to enable the application of Omnigen without the need for either sutures or glue. The application procedure takes approximately 15 minutes and the patients wear the lens continually. The McDonald study indicates that any improvement seen persists for at least three months. This study aims to expand on the work by McDonald et al. The study will be a randomised, parallel group study comparing Omnigen treatment applied with an OmniLenz BCL to OmniLenz BCL alone. The later treatment enables a degree of masking and for any difference to be attributable to the Omnigen rather than a contact lens. This is in line with the recommendations laid out be the DEWS group. Interim data and analysis will be conducted after enrolment of 20 patients. Following the first week application the eye will be assessed, and a further treatment applied for a further week. Therefore, the total treatment period will be two weeks with follow-up assessments at one and three months. At six months patients will complete an OSDI and EQ-5D assessment via email or post. The primary efficacy variability will be change in OSDI score, a patient reported scoring of dry eye symptoms. A number of clinical assessments of the ocular surface will also be performed as part of the secondary outcomes whilst the opportunity to measure a number of exploratory measures will enable further work following this study.

Conditions

Dry Eye

Keywords

dry eye disease; amniotic membrane; bandage contact lenses; symptoms; tear film stability; ocular surface damage

Outcome Measures

Primary Outcomes (1)

• Symptoms

  Symptoms assessed with the Ocular Surface Disease Index questionnaire \[0-100 range, higher worse\]

  12 weeks post baseline

Secondary Outcomes (7)

• Change in Symptoms over time

  2, 4,12 and 24 weeks post baseline

• Change in visual acuity over time

  2, 4, and 12 weeks post baseline

• Change in tear meniscus height over time

  2, 4, and 12 weeks post baseline

• Change in non-invasive tear breakup time over time

  2, 4, and 12 weeks post baseline

• Change in ocular surface staining over time

  2, 4, and 12 weeks post baseline

Other Outcomes (5)

• Exploratory sampling/imaging - tear film

  2, 4 and 12 weeks post baseline

• Exploratory sampling/imaging - keratocytes

  2, 4 and 12 weeks post baseline

• Exploratory sampling/imaging - corneal nerves

  2, 4 and 12 weeks post baseline

Study Arms (2)

Omnigen + OmniLenz

EXPERIMENTAL

Omnigen amniotic membrane 17mm disk with 6mm central aperture place under 18mm OmniLenz bandage contact lens

Device: Amniotic membrane Omnigen[TM]; Device: Bandage soft Contact Lens OmniLenz[R]

OmniLenz

ACTIVE COMPARATOR

Bandage contact lens alone

Device: Bandage soft Contact Lens OmniLenz[R]

Interventions

Amniotic membrane Omnigen[TM] DEVICE

17mm circular disk of processed amniotic tissue donated by mother after birth with a 6mm laser cut aperture to allow unimpeded vision https://www.nu-vision.co.uk/omnigen

Omnigen + OmniLenz

Bandage soft Contact Lens OmniLenz[R] DEVICE

18mm soft silicone-hydrogel contact lens https://www.nu-vision.co.uk/omnilenz

OmniLenz; Omnigen + OmniLenz

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aston University: lead
• NuVision: collaborator

Study Sites (1)

Aston University

Birmingham, West Midlands, B4 7ET, United Kingdom

Location

Related Publications (1)

• McDonald MB, Sheha H, Tighe S, Janik SB, Bowden FW, Chokshi AR, Singer MA, Nanda S, Qazi MA, Dierker D, Shupe AT, McMurren BJ. Treatment outcomes in the DRy Eye Amniotic Membrane (DREAM) study. Clin Ophthalmol. 2018 Apr 9;12:677-681. doi: 10.2147/OPTH.S162203. eCollection 2018.

  PMID: 29670328 BACKGROUND

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Andrew Hopkinson, PhD

  NuVision

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Patient will not be aware whether bandage contact lens has an amniotic membrane beneath in periphery or not Masked investigator will perform the clinical examinations
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Optometry

Model Details: 1 month baseline followed by randomisation into treatment or control and 6 months follow-up

Study Record Dates

• First Submitted: September 4, 2020
• First Posted: September 17, 2020
• Study Start: September 24, 2020
• Primary Completion: June 30, 2023
• Study Completion: July 30, 2023
• Last Updated: August 2, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After results publication
• Access Criteria: Contact j.s.w.wolffsohn@aston.ac.uk

Locations

GB (1)