Glaucoma, Ocular Hypertension, Open Angle Glaucoma
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICENanodropper
Device to apply liquid medication to eyes
Sponsors
University of California, San Francisco
Icare Finland Oy
Nanodropper, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Masking description
Study personnel who will evaluate the IOP and economic endpoints will be blinded to patients' assigned dispenser types for the duration of the study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 18 years old or older 2. Diagnosis of open-angle glaucoma (OAG) or ocular hypertension (OHT) 3. Use of prostaglandin analogue (PGA) eye drop 4. Stable disease status (no visual field loss progression or increase in IOP-lowering medications in the last 6 months)
Exclusion criteria
1. Uncontrolled glaucoma 2. Have had eye surgery (including laser procedures) within the past six months 3. Have a diagnosis of acute angle-closure glaucoma and/or other retinal diseases 4. Use of non-PGA class of IOP-lowering medication
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraocular Pressure (IOP) at Baseline | At Baseline | IOP measurement of the eye will be collected at the baseline visit using routine methods including Goldman applanation tonometry and pneumotonometer. |
| Intraocular Pressure (IOP) at Month 1 | 1 month | IOP measurement of the eye will be collected at the Month 1 visit using routine methods including Goldman applanation tonometry and pneumotonometer. |
| Intraocular Pressure (IOP) at Month 3 | 3 months | IOP measurement of the eye will be collected at the month 3 visit using routine methods including Goldman applanation tonometry and pneumotonometer. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Survey | 3 months | The following open-ended questions will be administered to participants randomized to the Nanodropper group at the end of the 3-month study. 1. Would you consider using the Nanodropper for your regular eye drop use in the future? (yes/no) 2. Did you find the Nanodropper easy to use? (yes/no) 3. Did using the Nanodropper cause more irritation compared to normal eye drop bottles? (yes/no) |
| Conjunctival Grading at Baseline | 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. |
| Conjunctival Grading at Month 3 | 3 months | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJulius Oatts, MD
University of California, San Francisco
Participant flow
Pre-assignment details
Baseline visit was done after a wash out period of 4-5 weeks was completed.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 70.2 number of years STANDARD_DEVIATION 10.3 |
| Participants with both Goldmann Applanation and Pneumotonometer IOP Measured | 6 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 6 Participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 6 |
| other Total, other adverse events | 0 / 7 | 0 / 6 |
| serious Total, serious adverse events | 0 / 7 | 0 / 6 |
Outcome results
None listed