Not Yet RecruitingPhase 2ACTRN12621000233820

Effects and recovery from daily and alternate-day instillation of various low-dose atropine eye drops

Effects on pupil size and recovery from daily and alternate-day instillation of various low-dose atropine eye drops in adults with healthy vision

Sponsor

UNSW Sydney

Enrollment

30 participants

Start Date

Mar 15, 2021

Study Type

Interventional

Conditions

Myopia

Summary

Atropine eye drops are known to affect pupil reactions and the ability of the eyes to focus on near objects. This study will quantify the effects of different concentrations of atropine eye drops on these ocular structures when given daily or in an alternate day dosing schedule.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 40 Yearss

Inclusion Criteria4

Normal general and ocular health
Adults aged 18-40 years
No allergy to atropine or preservatives
No history or risk of glaucoma

Exclusion Criteria7

Atropine eye drop use within 2 weeks prior to enrolment
Any eye diseases including inflammation, infection or allergy
History of allergic reaction to eye medications
Risk of glaucoma
Currently using any eye medications or systemic monoamine oxidase inhibitors (MAOIs)
Women who are pregnant, planning to become pregnant or breastfeeding\
History of cardiac disease

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Interventions

Arm 1: Drug Name: Atropine Sulphate Dose: 1 drop of 0.01% atropine sulphate eye drops in each eye Duration: Daily instillation for 7 days (7 doses) in one eye, every other day instillation for 7 da

Arm 1: Drug Name: Atropine Sulphate Dose: 1 drop of 0.01% atropine sulphate eye drops in each eye Duration: Daily instillation for 7 days (7 doses) in one eye, every other day instillation for 7 days (4 doses) in fellow eye Mode of administration: Topical eye drop instilled directly by subject before bed Adherence Monitoring: Participant compliance diary Arm 2: Drug Name: Atropine Sulphate Dose: 1 drop of 0.05% atropine sulphate eye drops in each eye Duration: Daily instillation for 7 days (7 doses) in one eye, every other day instillation for 7 days (4 doses) in fellow eye Mode of administration: Topical eye drop instilled directly by subject before bed Adherence Monitoring: Participant compliance diary