Ocular surface disease, dry eye disease Eye Diseases
Conditions
Interventions
For each eye drop of the investigational medicinal product (IMP), one dose is considered to be a single drop to both eyes and, in all stages, participants will continue to use their standard eye treat
Sponsors
University of Birmingham
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. =16 years of age 2. Moderate to severe dry eye symptoms (Ocular surface disease index (OSDI) score =33) 3. Lubricant requirement = 2 hourly 4. Stable on their current Serum Eye Drop (SED) therapy for >3 months (defined as no need for acute intervention in preceding 3 months) or have previously used SED as part of their ocular therapy
Exclusion criteria
Exclusion criteria: For Stages 1 and 2: 1. Unwilling to stop wearing contact lenses for the duration of the trial 2. Active seasonal allergic conjunctivitis (hay fever) 3. Presence of active ophthalmic infection: bacterial, fungal or viral 4. Presence of persistent infective corneal ulcers or current eye condition impacting on the trial as judged by a clinician 5. Known hypersensitivity to any of the components of the trial or procedural medication 6. History of drug, medication or alcohol abuse or addiction 7. Unable to understand, speak and write the English language 8. Vision insufficient to be able to do all the assessments as judged by the participant 9. Use of any investigational agent within 4 weeks of trial entry 10. Participation in another investigational medicinal product (IMP) or ophthalmic interventional clinical trial at the same time as the present trial 11. Participant has received a live attenuated vaccine within 30 days of trial entry 12. Participants on an unstable dose of antidepressants or not willing to stay on the same dose throughout the trial duration 13. Participants on an unstable standard daily dose of inhaled steroids or not willing to stay on the same dose throughout the trial duration PRN may differ but the standard daily dose prescribed must not vary). 14. Participants who are not willing or able to adhere to trial procedures and/or schedule 15. Participants with evidence of significant acute or chronic medical or psychiatric condition that, in the judgement of the investigator, would compromise the participant’s safety or ability to complete the trial. 16. Participants who are currently pregnant or breast-feeding 17. A woman of child-bearing potential (WOCBP) who does not agree to use a method of birth control (including barrier methods) during heterosexual intercourse from screening until 1 day after last trial treatment (see notes below) 18. Females of childbearing potential using hormonal contraception for less than 3 months prior to trial entry, or using hormonal contraception and not willing to stay on it for the duration of trial 19. Females taking Hormone Replacement Therapy (HRT) not willing to remain on treatment for the trial duration or have started HRT within the last 3 months prior to trial entry or are on an unstable dose of HRT 20. Male, if not vasectomised, who does not agree to use barrier contraception (condom) during heterosexual intercourse from screening through to 1 day after the last dose of trial treatment. For Stage 2 only 1. Previous entry into the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability: 1. Occurrence of related serious adverse events (SAEs) measured using study records over the 3-day trial period in Stage 1 and up to Day 49 in Stage 2 2. Worsening of symptoms recorded as adverse events as defined by CTCAE v5.0 and measured using study records over the 3-day trial period in Stage 1 and up to Day 49 in Stage 2 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Impact on Symptoms and Quality of Life measures comprise: 1.1. Vision-related function, ocular symptoms and environmental triggers measured using the Ocular Surface Disease Index (OSDI) via 12 questions resulting in an overall score between 0-100 at Baseline, Day 0 and Day 3 in Stage 1 and at Baseline and Days 0, 14, 28, 42 and 49 in Stage 2 1.2. Frequency and severity of ocular dryness measured using the Symptoms Assessment questionnaire in Dry Eye (SANDE) via 2 visual analogue scales measuring from 0 -100mm at Baseline, Days 0, 1, 2 and 3 in Stage 1 and at Baseline and Days 0, 1, 7, 14, 21, 28, 35, 42 and 49 in Stage 2 1.3. Dye eye symptoms and the impact of the condition on daily life measured using the Impact of Dry Eye on Everyday Life (IDEEL) measures via 57 questions organised into 3 modules (dry eye symptom bother, dry eye impact on daily life and dry eye treatment satisfaction) resulting in an overall score between 0-100 at Baseline, Day 0 and Day 3 in Stage 1 and at Baseline and Days 0, 14, 28, 42 and 49 in Stage 2 1.4. The sensitivity of the other questionnaires measured using a Perceived Changed in Health Questionnaire (PCQ) developed by the trials team comprising 5 questions related to eye symptom changes and 3 questions related to environmental impact changes on Day 3 in Stage 1 and at Days 14, 28, 42 and 49 in Stage 2 2. Visual function measures comprise: 2.1. Visual acuity measured using the LogMAR score on a logMAR visual acuity chart ranging from 1.0 logMAR (low vision) to -0.3 logMAR (good vision) in 0.1 logMAR steps at Baseline, Days 0, 1, 2 and 3 in Stage 1 and at Baseline and Days 0, 14, 28, 42 and 49 in Stage 2 2.2. Ability to read fixed short sentences and near contrast sensitivity measured using the LogMAR score assessed on an electronic tablet-based functional vision test (Optom Central App) to give a score for reading 14 sentences of decreasing print size between 1.0 and -0.1 logMAR, each consisting of 14 words (Radner reading speed te | — |
Countries
England, United Kingdom
Contacts
Public ContactTrial Mailbox
Outcome results
None listed