An interventional study of Nanodropper adaptor and Original eyedrop bottle/No Nanodropper in Glaucoma, Glaucoma, Open-Angle and Glaucoma, Primary Open Angle, sponsored by Nanodropper, Inc.. Completed at 2 sites in India. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-01-18.
Sponsored by Nanodropper, Inc. · Not applicable, Interventional, and Treatment
The purpose of this study is to evaluate the effect of microdrops vs. standard eyedrops of 0.5% timolol maleate in adults with primary open-angle glaucoma or ocular hypertension in terms of intraocular pressure-lowering efficacy and cardiovascular side effects.
This randomized, single-masked, parallel study aims to evaluate the safety and efficacy of microdrops of 0.5% timolol maleate administered with Nanodropper (experimental intervention) compared to standard drops of 0.5% timolol maleate (active comparator) in patients with primary open-angle glaucoma (OAG) or ocular hypertension (OHT) at Aravind Eye Hospital. At the beginning of the test day, baseline (pre-drug) intraocular pressure (IOP), resting heart rate (HR), and resting systolic and diastolic blood pressure (BP) measurements will be collected. Participants will be randomized to receive standard eyedrops or microdrops of 0.5% timolol maleate (one drop per eye), which will be administered by a trained technician at t = 0. IOP, HR, and BP measurements will be repeated by a masked investigator at t = 1, 2, 5, and 8 hours after drug administration.
1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.
This study's enrollment of 420 is above the median of 65 across 1,272 interventional studies indexed under Glaucoma.
Browse Glaucoma studies →This is the only study on the registry with Nanodropper, Inc. as lead sponsor.
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Exclusion Criteria:
Participants randomized to this arm will receive one standard drop of 0.5% timolol maleate in each eye.
Other: Original eyedrop bottle/No Nanodropper
Participants randomized to this arm will receive one microdrop of 0.5% timolol maleate in each eye. Microdrops will be dispensed from bottles with installed Nanodropper adaptors.
Device: Nanodropper adaptor
The Nanodropper adaptor is a sterile medical device that reduces the size of administered eyedrops by coupling to the original bottle.
The original eyedrop bottle dispenses standard eyedrops.
Intraocular pressure (mm Hg)
Time frame: 1 hour after drug administration
Intraocular pressure (mm Hg)
Time frame: 2 hours after drug administration
Intraocular pressure (mm Hg)
Time frame: 5 hours after drug administration
Intraocular pressure (mm Hg)
Time frame: 8 hours after drug administration
Resting heart rate (bpm)
Time frame: 1 hour after drug administration
Resting heart rate (bpm)
Time frame: 2 hours after drug administration
Resting heart rate (bpm)
Time frame: 5 hours after drug administration
Resting heart rate (bpm)
Time frame: 8 hours after drug administration
Resting systolic and diastolic blood pressure (mm Hg)
Time frame: 1 hour after drug administration
Resting systolic and diastolic blood pressure (mm Hg)
Time frame: 2 hours after drug administration
Resting systolic and diastolic blood pressure (mm Hg)
Time frame: 5 hours after drug administration
Resting systolic and diastolic blood pressure (mm Hg)
Time frame: 8 hours after drug administration
Plan to share: No
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This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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