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
• Status: Terminated
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Autoimmune Diseases
• Dry Eye Disease
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

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