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

NCT ID: NCT05181046

Last Updated: 2023-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 420 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-06
• Study Completion Date: 2022-12-19

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Original eyedrop bottle/No Nanodropper

Intervention Type: OTHER

The original eyedrop bottle dispenses standard eyedrops.

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.

Group Type: EXPERIMENTAL

Nanodropper adaptor

Intervention Type: DEVICE

The Nanodropper adaptor is a sterile medical device that reduces the size of administered eyedrops by coupling to the original bottle.

Interventions

Nanodropper adaptor

The Nanodropper adaptor is a sterile medical device that reduces the size of administered eyedrops by coupling to the original bottle.

Intervention Type: DEVICE

Original eyedrop bottle/No Nanodropper

The original eyedrop bottle dispenses standard eyedrops.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aravind Eye Care System

OTHER

Sponsor Role: collaborator

Nanodropper, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jennifer Steger, PhD

Role: STUDY_DIRECTOR

Nanodropper, Inc.

Locations

Aravind Eye Hospital

Madurai, , India

Aravind Eye Hospital

Puducherry, , India

Countries

India

Other Identifiers

nano001

Identifier Type: -

Identifier Source: org_study_id