search
Back to results

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

Primary Purpose

Dry Eye Disease

Status
Suspended
Phase
Phase 2
Locations
Australia
Study Type
Interventional
Intervention
KIO-101
Sponsored by
Kiora Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye Disease

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ophthalmic Trials Australia

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

0.15% KIO-101

0.3% KIO-101

Vehicle

Arm Description

.15% KIO-101 eyedrops

0.3% KIO-101 eyedrops

Vehicle eyedrops

Outcomes

Primary Outcome Measures

Change in Schirmer's 1 test
Change from Baseline to Week 12 for Schirmer's 1 test

Secondary Outcome Measures

Full Information

First Posted
November 17, 2022
Last Updated
September 20, 2023
Sponsor
Kiora Pharmaceuticals, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT05629364
Brief 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
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Suspended
Why Stopped
Study halted prematurely but potentially will resume
Study Start Date
March 15, 2023 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kiora Pharmaceuticals, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
132 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
0.15% KIO-101
Arm Type
Experimental
Arm Description
.15% KIO-101 eyedrops
Arm Title
0.3% KIO-101
Arm Type
Experimental
Arm Description
0.3% KIO-101 eyedrops
Arm Title
Vehicle
Arm Type
Placebo Comparator
Arm Description
Vehicle eyedrops
Intervention Type
Drug
Intervention Name(s)
KIO-101
Other Intervention Name(s)
DHODH inhibitor
Intervention Description
Randomized, Controlled
Primary Outcome Measure Information:
Title
Change in Schirmer's 1 test
Description
Change from Baseline to Week 12 for Schirmer's 1 test
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Hinds
Organizational Affiliation
Ophthalmic Trials Australia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ophthalmic Trials Australia
City
Teneriffe
State/Province
Queensland
ZIP/Postal Code
4005
Country
Australia

12. IPD Sharing Statement

Learn more about this 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

We'll reach out to this number within 24 hrs