An interventional study of Nanodropper adaptor and control in Glaucoma, Open-Angle and Ocular Hypertension, sponsored by University of Washington. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-14.
Sponsored by University of Washington · Not applicable, Interventional, and Supportive care
The purpose of this study is to evaluate the safety, efficacy, and usability of an eyedrop bottle adaptor that creates smaller eyedrops, Nanodropper, in an open-angle glaucoma/ocular hypertension patient population.
This 6-month prospective, randomized, single-masked, active-controlled, crossover (AB:BA) study aims to evaluate the safety, efficacy, and usability of Nanodropper-mediated microdrops of IOP-lowering medications (experimental intervention) compared to standard eyedrops of the same medications (active comparator) in open-angle glaucoma or ocular hypertension patients at Harborview Eye Institute, for which permission has been obtained. A pre-study visit will be held before the start of the trial in which participant clinical histories will be documented and an ocular examination will be performed. Patients will be enrolled in the study by satisfying all the inclusion and none of the exclusion criteria. This 6-month study will include three clinic visits: a baseline visit at t = 0, crossover visit at t = 3 months, and final visit at t = 6 months. At the baseline visit, patients will be randomly assigned to one of two treatment groups (1:1): Group 1 will administer standard eyedrops everyday for three months before crossing over to administering Nanodropper-mediated microdrops daily for three months and Group 2 will administer Nanodropper-mediated microdrops everyday for three months before crossing over to administering standard eyedrops daily for three months. At the visit that precedes the onset of the standard eyedrops treatment period, subjects will receive education on how to properly instill eyedrops. At the visit that precedes the onset of the Nanodropper treatment period, patients will receive education on how to properly instill eyedrops with the Nanodropper as well as one Nanodropper per bottle of prescription eyedrops. Patients will be instructed to use the Nanodropper with their bottle of eyedrops until the bottle is nearly depleted and they are due for a refill. Because the Nanodropper isn't reusable, subjects will be instructed to contact the clinic for additional Nanodroppers at the time that they refill their prescriptions. At each clinic visit, the IOP of each eye will be measured at 8 AM, 10 AM, and 12 PM using a calibrated Goldmann applanation tonometer by a masked evaluator. Additionally, surveys designed to assess whether Nanodropper impacts the financial burden and side effect profiles associated with chronic eyedrop use, as well as the usability of Nanodropper compared to standard eyedrop bottles, will be administered.
1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.
This study's planned enrollment of 150 is above the median of 65 across 1,272 interventional studies indexed under Glaucoma.
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Of its 154 completed or terminated interventional studies of FDA-regulated products, 132 (86%) have results posted.
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Exclusion Criteria:
Standard eyedrops of IOP-lowering medications
Device: control
Microdrops of IOP-lowering medications using Nanodropper adaptor
Device: Nanodropper adaptor
Patients will use their standard prescription for open-angle glaucoma or ocular hypertension with a Nanodropper attachment on the medication bottle.
Patients will use their prescribed IOP-lowering medication using standard eyedropper on the medication bottle.
IOP (mm Hg)
Mean IOP ± SEM following three months of treatment with each modality. The change in IOP from baseline and the percent change in IOP from baseline are supportive efficacy endpoints.
Time frame: 6 months
Adverse events
Survey scores of treatment-related adverse events that patients experience under each treatment modality will be compared
Time frame: 6 months
Premature bottle exhaustion
Survey scores of how frequently patients run out of their eyedrops before insurance will cover their next refill under each treatment modality will be compared
Time frame: 6 months
Socioeconomic strain
Survey scores of socioeconomic strain and the financial burden associated with chronic eyedrop use under each treatment modality will be compared
Time frame: 6 months
Plan to share: No
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