Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:26 PM
Ignite Modification Date:
2025-12-24 @ 9:26 PM
NCT ID:
NCT04553432
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04553432
Study Brief:
Protocol Section:
NCT04553432