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

Phase 2

Terminated

• Conditions: Dry Eye Disease
• Interventions: Drug: KIO-101

• Registration Number: NCT05629364
• Lead Sponsor: Kiora Pharmaceuticals, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-17
• Study First Submitted QC: 2022-11-17
• Study First Posted: 2022-11-29
• Study Start: 2023-03-15
• Status Verified: 2024-01
• Primary Completion: 2024-01-09
• Study Completion: 2024-01-09
• Last Update Submitted: 2024-01-09
• Last Update Posted: 2024-01-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
0.15% KIO-101	KIO-101	.15% KIO-101 eyedrops
0.3% KIO-101	KIO-101	0.3% KIO-101 eyedrops
Vehicle	KIO-101	Vehicle eyedrops

Primary Outcome Measures

Name	Time	Method
Change in Schirmer's 1 test	12 weeks	Change from Baseline to Week 12 for Schirmer's 1 test

Trial Locations

Locations (1)

Ophthalmic Trials Australia; 🇦🇺 Teneriffe, Queensland, Australia