Abstract
Background
One of the challenges of treating chronic ocular diseases like vernal keratoconjunctivitis (VKC), glaucoma, and ocular surface disease is patient adherence to topical medication. To support correct eye drop instillation, a variety of delivery aids have been developed for both single-dose and conventional multi-dose containers.
Methods
To evaluate Dropaid™ Single-dose, an eye drop delivery aid designed for single-dose containers, a usability study was conducted on 30 parents and caregivers of patients with VKC. After assessing the ability to squeeze a single eye drop from the single-dose container onto the eye of a pediatric medical dummy, the delivery aid was evaluated using an 11-point Likert scale on a variety of characteristics: from “very difficult” (−5) to “very easy” (+5).
Results
The majority of participants rated the task of opening the single-dose units (SDUs), preparing, and positioning the Dropaid™ Single-dose device as “very easy”. When providing a single eye drop from the container, 87% of participants rated the Dropaid™ Single-dose device as either “very easy” or “easy”, with a median rating score of +5.0 (interquartile range [IQR], 4.0–5.0). For general ease of use, 84% considered the delivery aid as either “very easy” or “easy”, with a median score of +4.0 (IQR, 3.0–5.0). Most participants (93%) rated Dropaid™ Single-dose as either “very comfortable” or “comfortable” to hold, with a median score of +5.0 (IQR, 4.0–5.0).
Conclusion
The Dropaid™ Single-dose delivery aid demonstrated rapid learning and ease of use across all stages of application, including opening the container, eye drop administration, and handling comfort. Although designed for use with single-dose containers to help eye drop instillation in patients with VKC, Dropaid™ Single-dose may provide a wider utility across a range of other ocular diseases such as glaucoma and dry eye.
Ethics Approval and Informed Consent
All study participants provided written informed consent to take part in the market research study and for their questionnaire responses to be analyzed and combined to produce a results report for sharing with the study sponsor, Santen SA. No Ethics Committee approval was required and confirmed by the Health Regulatory Authority. The study complied with the principles of the Declaration of Helsinki of 1964 as revised in 2013.
Acknowledgments
The authors acknowledge Richard Maver (Synergy Vision, UK) for medical writing and editorial assistance, based on the authors’ input and direction. This was funded by Santen SA in accordance with Good Publication Practice (GPP3) Guidelines (http://www.ismpp.org/gpp3).
Author Contributions
All authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article All authors made a significant contribution to the work reported, whether that is in the conception, study design, execution, acquisition of data, analysis and interpretation, or in all these areas; took part in drafting, revising or critically reviewing the article; gave final approval of the version to be published; have agreed on the journal to which the article has been submitted; and agree to be accountable for all aspects of the work.
Disclosure
A Dahlmann-Noor: Consultant/Advisor: Santen, SightGlass Vision, Théa. Honorarium recipient: CooperVision, Novartis, Santen, SightGlass Vision, Théa, Zeiss. Speaker: Santen, Zeiss. S Thomas: Consultant/Advisor: Glaucoma UK, Santen. Honorarium recipient: Santen. Speaker: Santen. JL Martin is an employee of Santen. K Lebrón Gutiérrez has no commercial or financial relationships to declare that could be construed as a potential conflict of interest.