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

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

Inclusion Criteria:Have a diagnosis of autoimmune disease (psoriatic arthritis, Systemic Lupus Erythematosus (SLE), or fibromyalgia) ≤ 10 yearsODS-VAS > 40 at Screening.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 0) visits, as confirmed by the investigatorHave a Best Spectacle Corrected Visual Accuity (BSCVA) score of 20/200 (+0.70 LogMAR) or better in both eyes at both the Screening and Baseline visitsHave a conjunctival hyperaemia score of Grade 2 or more on the Efron Scale in both eyesExclusion 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 safetyHave an autoimmune based vasculitisHave a history of RA > 10 years.Have a Schirmer's 1 test score of 0 to 1mm at ScreeningHave had a corneal transplant in either or both eyesHave 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