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

Not Applicable

Completed

• Conditions: Glaucoma, Open-Angle; Glaucoma; Glaucoma and Ocular Hypertension; Ocular Hypertension; Glaucoma, Primary Open Angle
• Interventions: Other: Original eyedrop bottle/No Nanodropper; Device: Nanodropper adaptor

• Registration Number: NCT05181046
• Lead Sponsor: Nanodropper, Inc.

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2021-11-06
• Study First Submitted: 2021-12-16
• Study First Submitted QC: 2022-01-04
• Study First Posted: 2022-01-06
• Primary Completion: 2022-12-19
• Study Completion: 2022-12-19
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-13
• Last Update Posted: 2023-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 420

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard eyedrops of 0.5% timolol maleate	Original eyedrop bottle/No Nanodropper	Participants randomized to this arm will receive one standard drop of 0.5% timolol maleate in each eye.
Nanodropper-mediated microdrops of 0.5% timolol maleate	Nanodropper adaptor	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.

Primary Outcome Measures

Name	Time	Method
Intraocular pressure (mm Hg)	8 hours after drug administration

Secondary Outcome Measures

Name	Time	Method
Resting heart rate (bpm)	8 hours after drug administration
Resting systolic and diastolic blood pressure (mm Hg)	8 hours after drug administration

Trial Locations

Locations (1)

Aravind Eye Hospital; 🇮🇳 Pondicherry, India