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

Status

Not yet recruiting

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12621000233820

Enrollment

Registered

2021-03-05

Start date

2021-03-15

Completion date

Unknown

Last updated

2021-03-16

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

Conditions

None listed

Brief 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.

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 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

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

18 Years to 40 Years

Healthy volunteers

Yes

Inclusion criteria

1) Normal general and ocular health 2) Adults aged 18-40 years 3) No allergy to atropine or preservatives 4) No history or risk of glaucoma

Exclusion criteria

1) Atropine eye drop use within 2 weeks prior to enrolment 2) Any eye diseases including inflammation, infection or allergy 3) History of allergic reaction to eye medications 4) Risk of glaucoma 5) Currently using any eye medications or systemic monoamine oxidase inhibitors (MAOIs) 6) Women who are pregnant, planning to become pregnant or breastfeeding\ 7) History of cardiac disease

Outcome results