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

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12619001325190

Enrollment

Registered

2019-09-27

Start date

2019-10-01

Completion date

2020-01-15

Last updated

2019-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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 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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

50 Years to No maximum

Healthy volunteers

Inclusion criteria

1) Diagnosis of symptomatic age-related presbyopia 2) Best distance corrected near visual acuity between 20/50 and 20/200

Exclusion criteria

1) Myopic manifest refractive error greater than -1.5-diopter in either eye 2) History of clinically significant or progressive retinal or ocular surface disease (including severe dry eye) in either eye 3) Clinically significant anisometropia, a difference in refractive power of two diopters or more between the two eyes 4) Unable to obtain best corrected photopic distance visual acuity of 20/25 or better in either eye 5) Maximal accommodative amplitude equal to 1.25-diopters in either eye 6) Prior cataract extraction with implantation of a multifocal IOL in either eye 7) Presence of untreated retinal tear, lattice degeneration or high-risk retinal lesion (in the investigator’s opinion) in either eye 8) Clinically significant corneal dystrophy, epithelial or endothelial disease, corneal irregularities or scarring 9) Concurrent use of any topical ophthalmic medication(s) including artificial tears during trial participation 10) Women of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control

Outcome results