GlaucomaNCT05181046
Evaluation of Nanodropper-mediated Microdrops vs. Standard Drops of 0.5% Timolol Maleate in Glaucoma Patients
A study testing Nanodropper adaptor and Original eyedrop bottle/No Nanodropper in people with Glaucoma and Glaucoma, Open-Angle, run by Nanodropper, Inc. at 2 sites in India.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma, Glaucoma, Open-Angle, Glaucoma, Primary Open Angle
- What is being tested?
- Nanodropper adaptor and Original eyedrop bottle/No Nanodropper
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 2 sitesIndia
- Study dates
- 6 Nov 2021to 19 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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
Who cannot join
- <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
Trial locations and contacts
2 sites in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Glaucoma, Glaucoma, Open-Angle, Glaucoma, Primary Open Angle, Glaucoma and Ocular Hypertension, Ocular Hypertension
- Being tested
- Nanodropper adaptor, Original eyedrop bottle/No Nanodropper
- Keywords
- Glaucoma, Eyedrops, Microdrops
- Medical subject headings
- Glaucoma, Glaucoma, Open-Angle, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nanodropper adaptorDevice
The Nanodropper adaptor is a sterile medical device that reduces the size of administered eyedrops by coupling to the original bottle.
Original eyedrop bottle/No NanodropperOther
The original eyedrop bottle dispenses standard eyedrops.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Nanodropper adaptor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular pressure (mm Hg)
Measured: 1 hour after drug administration
Intraocular pressure (mm Hg)
Measured: 2 hours after drug administration
Intraocular pressure (mm Hg)
Measured: 5 hours after drug administration
Intraocular pressure (mm Hg)
Measured: 8 hours after drug administration
Secondary outcomes (8)
Resting heart rate (bpm)
Measured: 1 hour after drug administration
Resting heart rate (bpm)
Measured: 2 hours after drug administration
Resting heart rate (bpm)
Measured: 5 hours after drug administration
Resting heart rate (bpm)
Measured: 8 hours after drug administration
Resting systolic and diastolic blood pressure (mm Hg)
Measured: 1 hour after drug administration
Resting systolic and diastolic blood pressure (mm Hg)
Measured: 2 hours after drug administration
Resting systolic and diastolic blood pressure (mm Hg)
Measured: 5 hours after drug administration
Resting systolic and diastolic blood pressure (mm Hg)
Measured: 8 hours after drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2022
- Study start6 Nov 2021
- Primary completion19 Dec 2022
- Study completion19 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 420 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanodropper, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Aravind Eye Care System
- Responsible party
- Sponsor
- Investigators
- Jennifer Steger, PhD, Study director, Nanodropper, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05181046
- Sponsor's protocol ID
- nano001
- Status last verified
- Jan 2023
- First submitted
- 16 Dec 2021
- Last updated
- 18 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05181046
- Acronym / sponsor ID
- nano001
- Conditions
- Glaucoma, Glaucoma, Open-Angle, Glaucoma, Primary Open Angle, Glaucoma and Ocular Hypertension, Ocular Hypertension
- Keywords
- Glaucoma, Eyedrops, Microdrops
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 420 participants (actual)
- Lead sponsor
- Nanodropper, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Aravind Eye Care System
- Study start
- 6 Nov 2021 (actual)
- Primary completion
- 19 Dec 2022 (actual)
- Study completion
- 19 Dec 2022 (actual)
- First posted
- 6 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard eyedrops of 0.5% timolol maleate | Active comparator | Other: Original eyedrop bottle/No NanodropperParticipants randomized to this arm will receive one standard drop of 0.5% timolol maleate in each eye. |
| Nanodropper-mediated microdrops of 0.5% timolol maleate | Experimental | Device: Nanodropper adaptorParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥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
Key exclusion criteria (8 listed)
- <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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nanodropper adaptorThe Nanodropper adaptor is a sterile medical device that reduces the size of administered eyedrops by coupling to the original bottle. | Device | Nanodropper-mediated microdrops of 0.5% timolol maleate |
| Original eyedrop bottle/No NanodropperThe original eyedrop bottle dispenses standard eyedrops. | Other | Standard eyedrops of 0.5% timolol maleate |
Primary outcome
Intraocular pressure (mm Hg)
Time frame: 1 hour after drug administration
Intraocular pressure (mm Hg)
Time frame: 2 hours after drug administration
Intraocular pressure (mm Hg)
Time frame: 5 hours after drug administration
Intraocular pressure (mm Hg)
Time frame: 8 hours after drug administration
8 secondary outcomes
Resting heart rate (bpm)
Time frame: 1 hour after drug administration
Resting heart rate (bpm)
Time frame: 2 hours after drug administration
Resting heart rate (bpm)
Time frame: 5 hours after drug administration
Resting heart rate (bpm)
Time frame: 8 hours after drug administration
Resting systolic and diastolic blood pressure (mm Hg)
Time frame: 1 hour after drug administration
Resting systolic and diastolic blood pressure (mm Hg)
Time frame: 2 hours after drug administration
Resting systolic and diastolic blood pressure (mm Hg)
Time frame: 5 hours after drug administration
Resting systolic and diastolic blood pressure (mm Hg)
Time frame: 8 hours after drug administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Steger, PhD study director
Nanodropper, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nanodropper adaptor and Original eyedrop bottle/No Nanodropper in people with Glaucoma and Glaucoma, Open-Angle, run by Nanodropper, Inc. at 2 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraocular pressure (mm Hg) (time frame: 1 hour after drug administration). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2023.