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

Non-inferiority of Nanodropper-mediated Microdrops vs. Standard Drops of 0.5% Timolol Maleate in Patients With Open-angle Glaucoma or Ocular Hypertension

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 420
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Madurai, India
    • Aravind Eye Hospital
  • Pondicherry, India
    • Aravind Eye Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard eyedrops of 0.5% timolol maleate; Participants randomized to this arm will receive one standard drop of 0.5% timolol maleate in each eye.	Other: Original eyedrop bottle/No Nanodropper; The original eyedrop bottle dispenses standard eyedrops.
Experimental: Nanodropper-mediated microdrops of 0.5% timolol maleate; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Intraocular pressure (mm Hg)	1 hour after drug administration
Intraocular pressure (mm Hg)	2 hours after drug administration
Intraocular pressure (mm Hg)	5 hours after drug administration
Intraocular pressure (mm Hg)	8 hours after drug administration

Secondary Outcome Measures

Outcome Measure	Time Frame
Resting heart rate (bpm)	1 hour after drug administration
Resting heart rate (bpm)	2 hours after drug administration
Resting heart rate (bpm)	5 hours after drug administration
Resting heart rate (bpm)	8 hours after drug administration
Resting systolic and diastolic blood pressure (mm Hg)	1 hour after drug administration
Resting systolic and diastolic blood pressure (mm Hg)	2 hours after drug administration
Resting systolic and diastolic blood pressure (mm Hg)	5 hours after drug administration
Resting systolic and diastolic blood pressure (mm Hg)	8 hours after drug administration

Collaborators and Investigators

• Sponsor: Nanodropper, Inc.
• Collaborators: Aravind Eye Care System
• Investigators: Study Director: Jennifer Steger, PhD, Nanodropper, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2021
• Primary Completion (Actual): December 19, 2022
• Study Completion (Actual): December 19, 2022

Study Registration Dates

• First Submitted: December 16, 2021
• First Submitted That Met QC Criteria: January 4, 2022
• First Posted (Actual): January 6, 2022

Study Record Updates

• Last Update Posted (Actual): January 18, 2023
• Last Update Submitted That Met QC Criteria: January 13, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Glaucoma; Microdrops; Eyedrops
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension; Pharmaceutical Solutions; Ophthalmic Solutions
• Other Study ID Numbers: nano001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes