Dose response measurements of low dose atropine eye drops over time

Phase 1

Recruiting

• Conditions: Myopia; Eye - Normal eye development and function; Eye - Diseases / disorders of the eye

• Registration Number: ACTRN12618000508279
• Lead Sponsor: SW Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-04-09
• Last Update Posted: 24 November 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 56

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) Recent atropine eye drop use 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in pupil size and responses as measured by a pupillometer[Baseline, 15 minutes post drop instillation, 30 minutes post drop instillation, 60 minutes post drop instillation (Primary time point), 360 minutes post drop instillation, 24 hours post drop instillation and 72 hours post drop instillation]

Secondary Outcome Measures

Name	Time	Method
Change in amplitude of accomodation as measured by push up tests[Baseline, 15 minutes post drop instillation, 30 minutes post drop instillation, 60 minutes post drop instillation, 360 minutes post drop instillation, 24 hours post drop instillation and 72 hours post drop instillation];Change in quality of vision as measured by the Quality of Vision Questionnaire[Baseline, 24 hours post drop instillation and 72 hours post drop instillation];Change in axial length as measured by IOLMaster[Baseline, 24 hours post drop instillation and 72 hours post drop instillation];Change in refractive error using autorefraction and subjective refraction[Baseline, 24 hours post drop instillation and 72 hours post drop instillation]