A Multi-Centre, Randomised, Controlled, Masked Phase 2 Study of the Safety and Efficacy of KIO-101 Ophthalmic Solution, Versus Vehicle Control in the Treatment of Dry Eye Disease in Patients With Autoimmune Disease

Study Overview
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Brief Summary
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A Multi-Centre, Randomised, Controlled, Masked Phase 2 Study of the Safety and Efficacy of KIO-101 Ophthalmic Solution, versus Vehicle Control in the treatment of Dry Eye Disease in Patients with Autoimmune Disease

Official Title
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A Multi-Centre, Randomised, Controlled, Masked Phase 2 Study of the Safety and Efficacy of KIO-101 Ophthalmic Solution, Versus Vehicle Control in the Treatment of Dry Eye Disease in Patients With Autoimmune Disease

Conditions
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Dry Eye Disease

Intervention / Treatment
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* Drug: KIO-101


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have a diagnosis of autoimmune disease (psoriatic arthritis, Systemic Lupus Erythematosus (SLE), or fibromyalgia) ≤ 10 years Have an Ocular Discomfort Score (ODS) score of ≥3 at Screening Have an average VAS score ≥ 50 at Screening; and ≥ 40 at Baseline, Visit 2/Day 1 Schirmer's 1 test >1 but < 10 mm at Screening. National Eye Institute (NEI) corneal fluorescein staining score of ≥ 4 at Screening (Day 14) provided that the total NEI score did not change > ± 2 grades from Screening (Day -14) to Baseline (Day 1) visits, as confirmed by the investigator Have a Best Spectacle Corrected Visual Accuity (BSCVA) score of 20/200 (+1.0 LogMAR) or better in both eyes at both the Screening and Baseline visits Have a conjunctival hyperaemia score of Grade 2 or more on the Efron Scale in both eyes Exclusion Criteria: Have a history or presence of any ocular disorder or condition (other than dry eye disease (DED)) in either eye that would, in the opinion of the investigator, likely interfere with the interpretation of the study results or subject safety Have an autoimmune based vasculitis Have a history of RA > 10 years. Have a Schirmer's 1 test score of 0 to 1mm at Screening Have had a corneal transplant in either or both eyes Have had puncta or intracanalicular plug present in either eyelid within 1 year prior to the Screening Visit or anticipated plug insertion or occlusion at any time during the study

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 0.15% KIO-101<br>.15% KIO-101 eyedrops | Drug: KIO-101<br>* Randomized, Controlled<br>* Other names: DHODH inhibitor;|
| Experimental: 0.3% KIO-101<br>0.3% KIO-101 eyedrops | Drug: KIO-101<br>* Randomized, Controlled<br>* Other names: DHODH inhibitor;|
| Placebo Comparator: Vehicle<br>Vehicle eyedrops | Drug: KIO-101<br>* Randomized, Controlled<br>* Other names: DHODH inhibitor;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Schirmer's 1 test | Change from Baseline to Week 12 for Schirmer's 1 test | 12 weeks |