Efficacy of the Nanodropper Device on Intraocular Pressure in Patients With Glaucoma

Glaucoma Clinical Trial

Official title:

Efficacy of the Nanodropper Device on Intraocular Pressure in Patients With Glaucoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05273385
• Other study ID #: 20-32530
• Status: Recruiting
• Phase: N/A
• Start date: October 10, 2022
• Est. completion date: December 10, 2024

Study information

• Verified date: November 2023
• Source: University of California, San Francisco
• Contact: Mari Costantini
• Phone: 415-353-2289
• Email: Mari.Costantini[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 10, 2024
• Est. primary completion date: December 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Ocular Hypertension
• Open Angle Glaucoma

Intervention

Device:
• Nanodropper
Device to apply liquid medication to eyes

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, San Francisco	Icare Finland Oy, Nanodropper, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	At Baseline
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.	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.	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.; Would you consider using the Nanodropper for your regular eye drop use in the future? (yes/no); Did you find the Nanodropper easy to use? (yes/no); Did using the Nanodropper cause more irritation compared to normal eye drop bottles? (yes/no)	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.	At baseline
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.	3 months