NCT05181046

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
420

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2021

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 6, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 16, 2021

Completed
21 days until next milestone

First Posted

Study publicly available on registry

January 6, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 19, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 19, 2022

Completed
Last Updated

January 18, 2023

Status Verified

January 1, 2023

Enrollment Period

1.1 years

First QC Date

December 16, 2021

Last Update Submit

January 13, 2023

Conditions

GlaucomaGlaucoma, Open-AngleGlaucoma, Primary Open AngleGlaucoma and Ocular HypertensionOcular Hypertension

Keywords

GlaucomaEyedropsMicrodrops

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (8)

  • 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

  • +3 more secondary outcomes

Study Arms (2)

Standard eyedrops of 0.5% timolol maleate

ACTIVE COMPARATOR

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

Other: Original eyedrop bottle/No Nanodropper

Nanodropper-mediated microdrops of 0.5% timolol maleate

EXPERIMENTAL

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

Interventions

Nanodropper adaptorDEVICE

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

Nanodropper-mediated microdrops of 0.5% timolol maleate
Original eyedrop bottle/No NanodropperOTHER

The original eyedrop bottle dispenses standard eyedrops.

Standard eyedrops of 0.5% timolol maleate

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥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

You may not qualify if:

  • \<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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Aravind Eye Hospital

Madurai, India

Location

Aravind Eye Hospital

Puducherry, India

Location

MeSH Terms

Conditions

GlaucomaGlaucoma, Open-AngleOcular Hypertension

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

  • Jennifer Steger, PhD

    Nanodropper, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2021

First Posted

January 6, 2022

Study Start

November 6, 2021

Primary Completion

December 19, 2022

Study Completion

December 19, 2022

Last Updated

January 18, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

IN(2)