Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1R44EY037603-01 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Eye Institute (NEI) | NIH |
| National Institutes of Health (NIH) | NIH |
Not provided
Not provided
Not provided
Not provided
Most patients with glaucoma use eye drops to lower their intraocular pressure. However, poor adherence to prescribed eye drop regimens can lead to significant loss of vision-related quality of life. This study will test the iDrop Device (iD2), a device-on-cap electronic platform monitor designed to accurately track when a research participant removes an eye drop bottle cap, wirelessly communicate usage data to a database accessible to researchers, and send on-demand alerts when a medication is due. A device capable of tracking eye drop usage and sending dosage alerts will test the hypothesis that electronic reminders improve medication adherence and help research subjects improve their eye drop taking behavior. While our primary focus is on glaucoma adherence, this device could also benefit those with other chronic eye conditions requiring regular eye drop treatment, such as dry eye, corneal endothelial disease, eye infections, and uveitis.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reminders during Stage 2 of study | Experimental | Stage 2 of the study is a 45-day period with 1:1 random assignment to determine the effect of no reminders vs. smart cap reminders if the drop is not used within the designated time window. This arm will receive smart cap reminders. |
|
| No reminders during Stage 2 of study | No Intervention | Stage 2 of the study is a 45-day period with 1:1 random assignment to determine the effect of no reminders vs. smart cap reminders if the drop is not used within the designated time window. This arm will not receive smart cap reminders. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eye drop cap monitor | Device | Eye drop cap monitor for improving adherence |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Adherence when Using the Dose Monitor | The iD2 device will track when the bottle cap is removed as a measure of medication adherence. Adherence will be measured throughout the study, comparing adherence when dose reminders are given against when no dose reminders are given. | 150 days |
| Measure | Description | Time Frame |
|---|---|---|
| Participant Satisfaction with the Dose Monitor | A participant's satisfaction with the dose monitor is measured using a questionnaire administered during the last study visit. 8 questions will use a 1-5 Likert scale, with 1 corresponding to "Strongly Disagree" and 5 corresponding to "Strongly Agree" in response to statements regarding device satisfaction, such as "I would use this device again." 7 questions are open-ended. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Steven Mansberger, MD, MPH | Contact | 503-413-8495 | clinicaltrials@deverseye.org |
| Name | Affiliation | Role |
|---|---|---|
| Steven Mansberger, MD, MPH | U n i v e r s a l A d h e r e n c e , L L C | Principal Investigator |
| Robert Kinast, MD | U n i v e r s a l A d h e r e n c e , L L C | Principal Investigator |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 | Aug 12, 2025 | Jun 17, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 12, 2025 | Jun 17, 2026 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D055118 | Medication Adherence |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
Not provided
Not provided
The trial includes 4 stages: Stage 1) a 30-day run-in period using the iD2 smart cap monitor without any reminders; Stage 2) a 45-day period with 1:1 random assignment to determine the effect of no reminders vs. smart cap reminders if the drop is not used within the designated time window; Stage 3) A 45-day period in which all participants receive the reminders; and Stage 4) A 30-day period without any reminders.
Not provided
Not provided
Not provided
Not provided
| 150 days |
| Brian Breiling, MS, BS |
| U n i v e r s a l A d h e r e n c e , L L C |
| Principal Investigator |
| Vince O'Malley | U n i v e r s a l A d h e r e n c e , L L C | Principal Investigator |
| D000074822 |
| Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |