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

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

Inclusion Criteria6

  • Adults aged between 18-40
  • Informed consent received
  • Have normal eye and general health
  • No reported allergy to atropine or preservatives
  • Willingness to comply with scheduled visits and other study procedures
  • No history of narrow-angle glaucoma or risk of glaucoma

Exclusion Criteria7

  • Atropine eye drop use prior to enrollment
  • Any ocular disease including inflammation or allergy
  • History of allergic reaction to any topical ophthalmic drugs
  • Contact lens wearer
  • Currently using topical ophthalmic drugs
  • Anyone who is taking any form of medication
  • Pregnant women, planning to become pregnant, or breast-feeding

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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


Locations(1)

NSW, Australia

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ACTRN12617000571370


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