RecruitingPhase 4ACTRN12617000571370

Effects of preserved and unpreserved low dose topical atropine eye drops on the ocular surface

Effects of low dose topical 0.01% atropine eye drops with and without benzalkonium chloride (BAK) preservative on the ocular surface in healthy adults

Sponsor

UNSW Sydney

Enrollment

20 participants

Start Date

Aug 3, 2017

Study Type

Interventional

Conditions

Dry Eye Myopia Ocular Surface Disease

Summary

Preservatives in eye drops, such as benzalkonium chloride (BAK), are necessary to prevent microbial contamination, but have been known to affect the comfort and health of the eye's structures, especially if used for long periods of time. This study will investigate the impact of BAK in participants using preserved and unpreserved atropine eye drops on their ocular comfort and health, as well as on the action of the drug itself.

Eligibility

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

Plain Language Summary

Simplified for easier understanding

Preservatives in eye drops help stop germs from growing, but they can also irritate the eye over time. This study is looking at whether the preservative benzalkonium chloride (BAK) in atropine eye drops causes more eye discomfort or health issues compared to preservative-free versions of the same drops. You may be eligible if: - You are between 18 and 40 years old - You have healthy eyes and no eye diseases - You have no allergy to atropine or preservatives - You do not wear contact lenses You may NOT be eligible if: - You are currently using any eye drops or eye medications - You are taking any form of medication - You are pregnant, planning to become pregnant, or breastfeeding - You have a history of glaucoma or allergic eye reactions Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Drug Name: Atropine Sulphate Dose: 1 drop of 0.01% (unpreserved) atropine sulphate eye drops once daily (at night) in each eye Duration: Four weeks Mode of administration: Topical eye drop Adheren

Drug Name: Atropine Sulphate Dose: 1 drop of 0.01% (unpreserved) atropine sulphate eye drops once daily (at night) in each eye Duration: Four weeks Mode of administration: Topical eye drop Adherence Monitoring: Participants will be required to keep a dosage log and to return unused eye drops to monitor adherence