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

Glaucoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05181046
• Other study ID #: nano001
• Status: Completed
• Phase: N/A
• Start date: November 6, 2021
• Est. completion date: December 19, 2022

Study information

• Verified date: January 2023
• Source: Nanodropper, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 420
• Est. completion date: December 19, 2022
• Est. primary completion date: December 19, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 a-agonist or ß-blocker within 30 days of study commencement

• History of receiving general anesthesia within the previous 30 days

• Pregnant women and nursing mothers

Related Conditions & MeSH terms

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

Intervention

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

Other:
• Original eyedrop bottle/No Nanodropper
The original eyedrop bottle dispenses standard eyedrops.

Locations

Country	Name	City	State
India	Aravind Eye Hospital	Madurai
India	Aravind Eye Hospital	Pondicherry

Sponsors (2)

Lead Sponsor	Collaborator
Nanodropper, Inc.	Aravind Eye Care System

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraocular pressure (mm Hg)		1 hour after drug administration
Primary	Intraocular pressure (mm Hg)		2 hours after drug administration
Primary	Intraocular pressure (mm Hg)		5 hours after drug administration
Primary	Intraocular pressure (mm Hg)		8 hours after drug administration
Secondary	Resting heart rate (bpm)		1 hour after drug administration
Secondary	Resting heart rate (bpm)		2 hours after drug administration
Secondary	Resting heart rate (bpm)		5 hours after drug administration
Secondary	Resting heart rate (bpm)		8 hours after drug administration
Secondary	Resting systolic and diastolic blood pressure (mm Hg)		1 hour after drug administration
Secondary	Resting systolic and diastolic blood pressure (mm Hg)		2 hours after drug administration
Secondary	Resting systolic and diastolic blood pressure (mm Hg)		5 hours after drug administration
Secondary	Resting systolic and diastolic blood pressure (mm Hg)		8 hours after drug administration