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NCT05629364 Clinical Trial

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

Dry Eye Disease Clinical Trial

Official title:
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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT05629364
Other study ID # KIO-101-2201
Secondary ID
Status Terminated
Phase Phase 2
First received
Last updated
Start date March 15, 2023
Est. completion date January 9, 2024

Study information
Verified date January 2024
Source Kiora Pharmaceuticals, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Terminated
Enrollment 4
Est. completion date January 9, 2024
Est. primary completion date January 9, 2024
Accepts healthy volunteers No
Gender All
Age group 21 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• KIO-101
Randomized, Controlled

Locations
Country Name City State
Australia Ophthalmic Trials Australia Teneriffe Queensland

Sponsors (1)
Lead Sponsor Collaborator
Kiora Pharmaceuticals, Inc.

Country where clinical trial is conducted

Australia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in Schirmer's 1 test Change from Baseline to Week 12 for Schirmer's 1 test 12 weeks
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