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

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12617000571370

Enrollment

Registered

2017-04-24

Start date

2017-08-03

Completion date

Unknown

Last updated

2021-02-16

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

Conditions

None listed

Brief summary

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.

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 Adherence Monitoring: Participants will be required to keep a dosage log and to return unused eye drops to monitor adherence

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) Adults aged between 18-40 2) Informed consent received 3) Have normal eye and general health 4) No reported allergy to atropine or preservatives 5) Willingness to comply with scheduled visits and other study procedures 6) No history of narrow-angle glaucoma or risk of glaucoma

Exclusion criteria

1) Atropine eye drop use prior to enrollment 2) Any ocular disease including inflammation or allergy 3) History of allergic reaction to any topical ophthalmic drugs 4) Contact lens wearer 5) Currently using topical ophthalmic drugs 6) Anyone who is taking any form of medication 7) Pregnant women, planning to become pregnant, or breast-feeding

Outcome results