Not Yet RecruitingPhase 2ACTRN12619001325190

Topical Miotic Administered by the AcuStream Delivery System in Subjects with Presbyopia

A Double-Masked, Randomised Study of a Topical Miotic Administered by the AcuStream Delivery System on Near Visual Acuity in Subjects with Age-Related Presbyopia

Sponsor

Kedalion Therapeutics Australia Pty Ltd

Enrollment

60 participants

Start Date

Oct 1, 2019

Study Type

Interventional

Conditions

Presbyopia

Summary

KT-101-02 is a multi-centre, randomised, double-masked, exploratory study of topical ocular miotic agents when administered as a microdose with the Kedalion AcuStream™ delivery system to improve symptoms of presbyopia. Pre-clinical testing evaluation and previous clinical trials show that miotics delivered through the AcuStream™ device have shown efficacy and safety for the treatment of presbyopia. This study will further define the efficacy benefits as well as tolerability and side effects.

Eligibility

Sex: Both males and femalesMin Age: 50 Yearss

Inclusion Criteria2

Diagnosis of symptomatic age-related presbyopia
Best distance corrected near visual acuity between 20/50 and 20/200

Exclusion Criteria11

Myopic manifest refractive error greater than -1.5-diopter in either eye
History of clinically significant or progressive retinal or ocular surface disease (including severe dry eye) in either eye
Clinically significant anisometropia, a difference in refractive power of two diopters or more between the two eyes
Unable to obtain best corrected photopic distance visual acuity of 20/25 or better in either eye
Maximal accommodative amplitude equal to 1.25-diopters in either eye
Prior cataract extraction with implantation of a multifocal IOL in either eye
Presence of untreated retinal tear, lattice degeneration or high-risk retinal lesion (in the
investigator’s opinion) in either eye
Clinically significant corneal dystrophy, epithelial or endothelial disease, corneal irregularities or scarring
Concurrent use of any topical ophthalmic medication(s) including artificial tears during trial participation
Women of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control

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Interventions

Dose: KT-101 will be self-administered by patients as a single, topical microdose (10ul) in 3 concentrations (1%, 2% and 4%) along with a placebo controlled arm. Adherence will be monitored through p

Dose: KT-101 will be self-administered by patients as a single, topical microdose (10ul) in 3 concentrations (1%, 2% and 4%) along with a placebo controlled arm. Adherence will be monitored through physician observation and record in clinic. Duration: Each patient will receive a single dose of randomized treatment in each eye for one day. Mode: Single stream, topical ophthalmic microdose (10ul) using AcuStream delivery system.