Clinical trial NCT05181046: Evaluation of Nanodropper-mediated Microdrops vs. Standard Drops of 0.5% Timolol Maleate in Glaucoma Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glaucoma
Glaucoma, Open-Angle
Glaucoma, Primary Open Angle
Glaucoma and Ocular Hypertension
Ocular Hypertension
Keywords: Glaucoma
Eyedrops
Microdrops
Lead sponsor: Nanodropper, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Aravind Eye Care System
First posted: 2022-01-06
Enrollment: 420
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Intraocular pressure (mm Hg)
timeFrame: 1 hour after drug administration
measure: Intraocular pressure (mm Hg)
timeFrame: 2 hours after drug administration
measure: Intraocular pressure (mm Hg)
timeFrame: 5 hours after drug administration
measure: Intraocular pressure (mm Hg)
timeFrame: 8 hours after drug administration
Secondary outcomes:
measure: Resting heart rate (bpm)
timeFrame: 1 hour after drug administration
measure: Resting heart rate (bpm)
timeFrame: 2 hours after drug administration
measure: Resting heart rate (bpm)
timeFrame: 5 hours after drug administration
measure: Resting heart rate (bpm)
timeFrame: 8 hours after drug administration
measure: Resting systolic and diastolic blood pressure (mm Hg)
timeFrame: 1 hour after drug administration
measure: Resting systolic and diastolic blood pressure (mm Hg)
timeFrame: 2 hours after drug administration
measure: Resting systolic and diastolic blood pressure (mm Hg)
timeFrame: 5 hours after drug administration
measure: Resting systolic and diastolic blood pressure (mm Hg)
timeFrame: 8 hours after drug administration
Other outcomes:
Locations:
city: Madurai
country: India
facility: Aravind Eye Hospital
city: Pondicherry
country: India
facility: Aravind Eye Hospital
Study officials:
affiliation: Nanodropper, Inc.
name: Jennifer Steger, PhD
role: STUDY_DIRECTOR
References: