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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-15

Study Completion Date

2024-01-09

Brief Summary

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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

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Detailed Description

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Conditions

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Dry Eye Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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0.15% KIO-101

.15% KIO-101 eyedrops

Group Type EXPERIMENTAL

KIO-101

Intervention Type DRUG

Randomized, Controlled

0.3% KIO-101

0.3% KIO-101 eyedrops

Group Type EXPERIMENTAL

KIO-101

Intervention Type DRUG

Randomized, Controlled

Vehicle

Vehicle eyedrops

Group Type PLACEBO_COMPARATOR

KIO-101

Intervention Type DRUG

Randomized, Controlled

Interventions

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KIO-101

Randomized, Controlled

Intervention Type DRUG

Other Intervention Names

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DHODH inhibitor

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No