Clinical Evaluation of a Novel Electromechanical Topical Ocular Drug Delivery System: Two Phase 1 Proof of Concept Studies

Clinical Evaluation of a Novel Electromechanical Topical Ocular Drug Delivery System: Two Phase 1 Proof of Concept Studies

Self-administration of topical ophthalmic therapies remains challenging for many patients as errors due to improper technique are common. The aim of the current studies was to evaluate a novel electromechanical topical ocular drug delivery device designed to facilitate precise dosing and accurate de...

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Bibliographic Details
Published in:Clinical ophthalmology (Auckland, N.Z.) Vol. 14; pp. 139 - 147
Main Authors: Quiroz-Mercado, Hugo, Ivri, Ehud, Gonzalez-Salinas, Roberto, Kourtis, Iraklis C, Gilbert, Joseph, Pérez-Vázquez, José Francisco, Blumenkranz, Mark, Jiménez-Román, Jesús, Marcellino, George
Format: Journal Article
Language:English
Published: New Zealand Dove Medical Press Limited 2020
Taylor & Francis Ltd
Dove
Dove Medical Press
Subjects:
Care and treatment
Comparative analysis
Cornea
Dosage and administration
Drug delivery systems
Drug dosages
Glaucoma
intraocular pressure
Latanoprost
mydriasis
Novels
Ophthalmic agents
Original Research
Patient compliance
Patients
phenylephrine
safety
Studies
topical ocular drug delivery
Transdermal drug delivery systems
Tropicamide
Mexico
latanoprost
intraocular pressure
mydriasis
glaucoma
phenylephrine
safety
tropicamide
topical ocular drug delivery
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Summary:Self-administration of topical ophthalmic therapies remains challenging for many patients as errors due to improper technique are common. The aim of the current studies was to evaluate a novel electromechanical topical ocular drug delivery device designed to facilitate precise dosing and accurate delivery with substantially lower drug exposure than conventional eye drops. Two randomized Phase 1 studies were performed to evaluate the efficacy and safety of a single dose of a topical ophthalmic solution administered as a ~9 μL microfluid stream via the test device compared with a ~30-40 μL drop delivered via conventional dropper in healthy subjects (Trial 1) and glaucoma patients (Trial 2). In Trial 1, a 1% tropicamide/2.5% phenylephrine solution was administered via the test device in one eye and by conventional dropper in the contralateral eye. Pupil dilation was measured at 30 min intervals post-instillation and subject comfort was assessed using a visual analogue scale (range, 0-100). In Trial 2, patients were randomized to receive latanoprost 0.005% via the test device or conventional dropper. Intraocular pressure was measured at baseline and 4-8 hrs post-instillation. In Trial 1 (N=20), mean (SD) pupil diameter 30 mins post-instillation increased by 3.4 (0.9) and 3.5 (1.0) mm in the test and control eyes, respectively. The mean comfort score was 81.7 for the test device versus 57.3 for conventional dropper delivery. In Trial 2 (N=18), the mean change in intraocular pressure following administration of latanoprost was -5.0 (1.8) and -4.3 (3.3) mm Hg in the test and control groups, respectively. No serious adverse events were observed in either study. Administration of a single dose of topical ophthalmic therapy via an electromechanical drug delivery device resulted in comparable effects on pupil dilation and intraocular pressure with lower drug exposure and increased patient comfort compared with conventional dropper delivery.
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ISSN:1177-5467
1177-5483
1177-5483
DOI:10.2147/OPTH.S221749