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

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Device: Nanodropper adaptor
* Other: Original eyedrop bottle/No Nanodropper


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard eyedrops of 0.5% timolol maleate<br>Participants randomized to this arm will receive one standard drop of 0.5% timolol maleate in each eye. | Other: Original eyedrop bottle/No Nanodropper<br>* The original eyedrop bottle dispenses standard eyedrops.<br>|
| Experimental: Nanodropper-mediated microdrops of 0.5% timolol maleate<br>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<br>* The Nanodropper adaptor is a sterile medical device that reduces the size of administered eyedrops by coupling to the original bottle.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glaucoma, Eyedrops, Microdrops