Efficacy of the Nanodropper Device on Intraocular Pressure in Patients With Glaucoma
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Secondary Aim: Assess access to eye drops and frequency of pharmacy refill requests.
Stable glaucoma participants and ocular hypertension participants of all ages will be randomized to either use Nanodropper for drop administration in both eyes OR administer drops regularly (standard of care) in both eyes. Participants will be followed-up at 2, 4, and 6 months.
New bottles of medication and any prescription refills required during the study will be purchased and provided to study participants.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Glaucoma Arm: Nanodropper Participants will receive the Nanodropper with instructions and attend clinic visits at 2, 4, and 6 months. Surveys will be administered to adult participants and parents of child participants (under 18 years of age) in clinic at the end of the study that will be conducted as an open-ended interview expected to take less than 5 minutes |
Device: Nannodropper
Device to apply liquid medication to eyes
|
| Experimental: Glaucoma Arm: Nanodropper + iCARE Participants will receive the Nanodropper with instructions and attend clinic visits at 2, 4, and 6 months. Surveys will be administered to adult participants and parents of child participants (under 18 years of age) in clinic at the end of the study that will be conducted as an open-ended interview expected to take less than 5 minutes. Along with following protocol for the Nanodropper portion, participants 6 patients will also measure their IOP at home at Months 1, 3, 5 |
Device: Nannodropper
Device to apply liquid medication to eyes
Device: iCare
Device used at home to measure eye pressure
|
| Active Comparator: Glaucoma Arm: Standard of Care Dropper Participants will receive standard of care eye dropper with instructions and attend regular clinic visits. |
Device: Standard of care eye dropper
Device to apply liquid medication to eyes
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Mean intraocular pressure (IOP) over time [At baseline]
IOP a measurement of the fluid pressure inside the eye and will be collected at each visit using routine methods. The mean and standard deviation will be reported by group at Baseline
- Mean intraocular pressure (IOP) over time [2 months]
IOP a measurement of the fluid pressure inside the eye and will be collected at each visit using routine methods. The mean and standard deviation will be reported by group at the Month 2 clinic visit.
- Mean intraocular pressure (IOP) over time [4 months]
IOP a measurement of the fluid pressure inside the eye and will be collected at each visit using routine methods. The mean and standard deviation will be reported by group at the Month 4 clinic visit.
- Mean intraocular pressure (IOP) over time [6 months]
IOP a measurement of the fluid pressure inside the eye and will be collected at each visit using routine methods. The mean and standard deviation will be reported by group at the Month 6 clinic visit.
Eligibility Criteria
Criteria
Inclusion Criteria:
Glaucoma Arm: Children:
-
Patients with either stable glaucoma or ocular hypertension.
-
Patients who are 2-17 years old and younger than 18 years old will be enrolled.
-
Participants are on 1-2 IOP- lowering prescriptions, with no clinical indications of disease progression for at least12 months prior to the time of recruitment
Glaucoma Arm: Adult:
-
Patients with stable glaucoma.
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Patients who are 18+ years old.
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Participants are on 1-2 IOP- lowering prescriptions, with no clinical indications of disease progression for at least12 months prior to the time of recruitment
Exclusion Criteria:
Glaucoma Arm: Children:
-
Patients with uncontrolled glaucoma will not be enrolled.
-
Patients who are newborns, infants, or toddlers (< 2 years old) will not be enrolled.
Glaucoma Arm: Adult:
- Patients with uncontrolled glaucoma will not be enrolled.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of California, San Francisco | San Francisco | California | United States | 94143 |
Sponsors and Collaborators
- University of California, San Francisco
- Nanodropper, Inc.
- Icare Finland Oy
Investigators
- Principal Investigator: Julius Oatts, MD, University of California, San Francisco
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 20-32530