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

Sponsor

Nanodropper, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05181046

Collaborator

Aravind Eye Care System (Other)

420

Enrollment

Locations

Arms

5.8

Anticipated Duration (Months)

210

Patients Per Site

36.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma Glaucoma, Open-Angle Glaucoma, Primary Open Angle Glaucoma and Ocular Hypertension Ocular Hypertension	Device: Nanodropper adaptor Other: Original eyedrop bottle/No Nanodropper	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

420 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 6, 2021

Anticipated Primary Completion Date :

May 1, 2022

Anticipated Study Completion Date :

May 1, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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