Evaluation of Nanodropper-mediated Microdrops vs. Standard Drops of 0.5% Timolol Maleate in Glaucoma Patients

Nanodropper

Status: Completed

Conditions: Glaucoma, Primary Open Angle; Glaucoma; Ocular Hypertension; Glaucoma and Ocular Hypertension; Glaucoma, Open-Angle

Treatments: Other: Original eyedrop bottle/No Nanodropper; Device: Nanodropper adaptor

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05181046

nano001

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 420 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ≥18 years old
• Recent diagnosis of primary OAG or OHT
• Treatment-naive (not currently using ophthalmic medication)
• Baseline IOP between 21-35 mm Hg
• Corrected Snellen visual acuity of 6/60 or better in each eye

Exclusion criteria

• <18 years old
• A recent history (within the past 6 months) of ocular trauma, infection, or uveitis
• Baseline IOP <21 mm Hg or >35 mm Hg
• History of cardiovascular, pulmonary, cerebrovascular, or chronic renal disease
• History of borderline or uncontrolled systemic arterial hypertension
• Use of any systemic α-agonist or β-blocker within 30 days of study commencement
• History of receiving general anesthesia within the previous 30 days
• Pregnant women and nursing mothers

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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420 participants in 2 patient groups

Standard eyedrops of 0.5% timolol maleate

Active Comparator group

Description:

Participants randomized to this arm will receive one standard drop of 0.5% timolol maleate in each eye.

Treatment:

Other: Original eyedrop bottle/No Nanodropper

Nanodropper-mediated microdrops of 0.5% timolol maleate

Experimental group

Description:

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.

Treatment:

Device: Nanodropper adaptor