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A similar study has been published by other groups and this study is no longer needed.
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| Name | Class |
|---|---|
| Icare Finland Oy | INDUSTRY |
| Nanodropper, Inc. | INDUSTRY |
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Glaucoma is the leading cause of irreversible blindness worldwide. Previous studies demonstrate that smaller eye drops used in the treatment of glaucoma are just as efficacious as their larger counterparts. The proposed study hopes to demonstrate the non-inferiority of using Nanodropper to lower intraoccular pressure (IOP) in glaucoma patients compared to standard of care eye drops.
The proposed study strives to demonstrate the non-inferiority of using Nanodropper to lower IOP in glaucoma patients compared to standard of care (SOC) eye drops in a randomized trial.
Primary Aim: Demonstrate non-inferiority of using Nanodropper to lower IOP compared to standard of care eye drops in glaucoma patients.
Stable glaucoma participants and ocular hypertension participants of ages 18+ will be randomized to either use Nanodropper for eye drop administration in both eyes OR administer drops regularly (standard of care) in both eyes. Participants will be followed-up at 1 month and 3 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nanodropper | Experimental | Participants will receive the Nanodropper with instructions and attend clinic visits at baseline, 1, and 3 months. Participants will administer their eye drops using the Nanodropper. |
|
| Standard of Care Dropper | No Intervention | Participants will receive standard of care eye dropper with instructions and attend clinic visits at baseline, 1, and 3 months. Participants will administer their eye drops using the standard of care eye dropper. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nanodropper | Device | Device to apply liquid medication to eyes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intraocular Pressure (IOP) at Baseline | IOP measurement of the eye will be collected at the baseline visit using routine methods including Goldman applanation tonometry and pneumotonometer. | At Baseline |
| Intraocular Pressure (IOP) at Month 1 | IOP measurement of the eye will be collected at the Month 1 visit using routine methods including Goldman applanation tonometry and pneumotonometer. | 1 month |
| Intraocular Pressure (IOP) at Month 3 | IOP measurement of the eye will be collected at the month 3 visit using routine methods including Goldman applanation tonometry and pneumotonometer. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Survey | The following open-ended questions will be administered to participants randomized to the Nanodropper group at the end of the 3-month study.
| 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julius Oatts, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94143 | United States |
Individual participant data that underlie the results after deidentification(text, tables, figures, and appendices).
Immediately following publication. No end date.
Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose. For individual participant data meta-analysis.
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Baseline visit was done after a wash out period of 4-5 weeks was completed.
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard of Care | This group administered the IOP lowering eye drops as standard of care. |
| FG001 | Nanodropper | This group administered the IOP lowering eye drops using the Nanodropper. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Only the 13 patients with complete data were analyzed.
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard of Care | This group administered the IOP lowering eye drops as standard of care. |
| BG001 | Nanodropper | This group administered the IOP lowering eye drops using the Nanodropper. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Intraocular Pressure (IOP) at Baseline | IOP measurement of the eye will be collected at the baseline visit using routine methods including Goldman applanation tonometry and pneumotonometer. | Only patients with completed data was analyzed. | Posted | Mean | Standard Deviation | mmHg | At Baseline |
|
from enrollment until end of follow-up, up to 13 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard of Care | This group administered the IOP lowering eye drops as standard of care. |
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This study was terminated due to low enrollment numbers.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ying Han | UCSF | 415-353-2020 | ying.han@ucsf.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan: Study Protocol with SAP | Nov 2, 2020 | Jan 15, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005902 | Glaucoma, Open-Angle |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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Study personnel who will evaluate the IOP and economic endpoints will be blinded to patients' assigned dispenser types for the duration of the study.
| Conjunctival Grading at Baseline | Conjunctival grading will be performed by a masked ophthalmologist at the baseline study visit. Grading will be performed with redness graded on a scale of 0-100 using the bulbar redness 5-picture validated scale. A grade of 0 is considered to be the least red and therefore a better outcome. A grade of 100 is considered the most red and therefore a worse outcome. | At baseline |
| Conjunctival Grading at Month 3 | Conjunctival grading will be performed by a masked ophthalmologist the 3 month study visit. Grading will be performed with redness graded on a scale of 0-100 using the bulbar redness grading 5-picture validated scale. A grade of 0 is considered to be the least red and therefore a better outcome. A grade of 100 is considered the most red and therefore a worse outcome. | 3 months |
| BG002 | Total | Total of all reporting groups |
| number of years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Participants with both Goldmann Applanation and Pneumotonometer IOP Measured | Count of Participants | Participants |
|
|
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| Primary | Intraocular Pressure (IOP) at Month 1 | IOP measurement of the eye will be collected at the Month 1 visit using routine methods including Goldman applanation tonometry and pneumotonometer. | Only patients with completed data was analyzed. | Posted | Mean | Standard Deviation | mmHg | 1 month |
|
|
|
| Primary | Intraocular Pressure (IOP) at Month 3 | IOP measurement of the eye will be collected at the month 3 visit using routine methods including Goldman applanation tonometry and pneumotonometer. | Only data from participants who completed all visits were analyzed. | Posted | Mean | Standard Deviation | mmHg | 3 months |
|
|
|
| Secondary | Survey | The following open-ended questions will be administered to participants randomized to the Nanodropper group at the end of the 3-month study.
| Only the participants randomized to the nanodropper arm was surveyed. | Posted | Count of Participants | Participants | 3 months |
|
|
|
| Secondary | Conjunctival Grading at Baseline | Conjunctival grading will be performed by a masked ophthalmologist at the baseline study visit. Grading will be performed with redness graded on a scale of 0-100 using the bulbar redness 5-picture validated scale. A grade of 0 is considered to be the least red and therefore a better outcome. A grade of 100 is considered the most red and therefore a worse outcome. | We used the number of eyes not participants for this analysis. | Posted | Mean | Standard Deviation | scores on a scale | At baseline | Eyes | Eyes |
|
|
|
| Secondary | Conjunctival Grading at Month 3 | Conjunctival grading will be performed by a masked ophthalmologist the 3 month study visit. Grading will be performed with redness graded on a scale of 0-100 using the bulbar redness grading 5-picture validated scale. A grade of 0 is considered to be the least red and therefore a better outcome. A grade of 100 is considered the most red and therefore a worse outcome. | We used the number of eyes not participants for this analysis. | Posted | Mean | Standard Deviation | scores on a scale | 3 months | eyes | eyes |
|
|
|
| 0 |
| 7 |
| 0 |
| 7 |
| 0 |
| 7 |
| EG001 | Nanodropper | This group administered the IOP lowering eye drops using the Nanodropper. | 0 | 6 | 0 | 6 | 0 | 6 |
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| Pneumotonometer Right Eye |
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| Pneumotonometer Left Eye |
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| Pneumotonometer Right Eye |
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| Pneumotonometer Left Eye |
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| Missing |
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| 2. Did you find the Nanodropper easy to use? (yes/no) |
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| 3. Did using the Nanodropper cause more irritation compared to normal eye drop bottles? (yes/no) |
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| Eyes |
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| eyes |
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