GlaucomaNCT03417453
Eye Drop Dispensers: Safety, Efficacy and Comfort.
A study testing Eye Drop Dispenser TYPE Opticare and Eye Drop Dispenser Autodrop in people with Glaucoma and Cataract, run by Wolfson Medical Center at 1 site in Israel.
Trial summary
One aspect to eye drop adherence is successful instillation of the drops; however, it is well known that many patients struggle with this task. Difficulties may include aiming their drops,extending their neck, preventing excess drop leakage, avoiding contamination of the bottle tip and generating enough force to expel… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Glaucoma, Cataract, Healthy Subjects
- What is being tested?
- Eye Drop Dispenser TYPE Opticare and Eye Drop Dispenser Autodrop
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Apr 2019to 1 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- glaucoma patients
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Asaf Achiron
Tel Aviv, 64512
asaf Achiron, MD, 524853549, achironasaf@gmail.com
Keren, +97235035713, achironasaf@gmail.com
About this study
One aspect to eye drop adherence is successful instillation of the drops; however, it is well known that many patients struggle with this task. Difficulties may include aiming their drops,extending their neck, preventing excess drop leakage, avoiding contamination of the bottle tip and generating enough force to expel a drop from the bottle. Instillation aids are devices that aim to ameliorate one or more of these barriers.
Several eye drop dispensers had been developed in order to improved outcomes of eye drop instillation, including improved rates of successful administration and increased patient satisfaction compared to standard eye drop bottles.
In this study we aim to compare the eye drops various installation aids
Read the detailed description
subject will evaluate 2 dispensers by questioners. efficacy and safety of each one will be evaluated.
- Conditions
- Glaucoma, Cataract, Healthy Subjects
- Being tested
- Eye Drop Dispenser TYPE Opticare, Eye Drop Dispenser Autodrop
- Keywords
- normal patients, eye drops dispensers, aids, glacuoma, cataract
- Medical subject headings
- Glaucoma, Cataract, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eye Drop Dispenser TYPE OpticareDevice
Subject will apply normal saline eye drops to them-self with various eye drop dispensers.
Assessment of ease of use will be conducted by questioners.
Eye Drop Dispenser AutodropDevice
Eye Drop Dispenser Autodrop
| Study group | Role | What they receive |
|---|---|---|
| Eye Drop Dispenser TYPE Opticare | Active comparator | subject will assess TYPE 1 dispenser Receives: Device: Eye Drop Dispenser TYPE Opticare |
| Eye Drop Dispenser Autodrop | Active comparator | subject will assess Autodrop dispenser Receives: Device: Eye Drop Dispenser Autodrop |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of correct application of eye drops to the eye without missing conducted by questioners.
assessment of correct application of eye drops to the eye without missing
Measured: 5 seconds after instillation of eye drops
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2018
- Study start1 Apr 2019 (estimated)
- Primary completion1 Jan 2020 (estimated)
- Study completion1 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wolfson Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Asaf Achiron, Wolfson Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03417453
- Sponsor's protocol ID
- Eye Drop Dispensers
- Status last verified
- Apr 2018
- First submitted
- 7 Jan 2018
- Last updated
- 1 May 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eye Drop Dispensers: Safety, Efficacy and Comfort.
- ClinicalTrials.gov ID
- NCT03417453
- Acronym / sponsor ID
- Eye Drop Dispensers
- Conditions
- Glaucoma, Cataract, Healthy Subjects
- Keywords
- normal patients, eye drops dispensers, aids, glacuoma, cataract
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Wolfson Medical CenterOther government
- Study start
- 1 Apr 2019 (estimated)
- Primary completion
- 1 Jan 2020 (estimated)
- Study completion
- 1 Jan 2020 (estimated)
- First posted
- 31 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
One aspect to eye drop adherence is successful instillation of the drops; however, it is well known that many patients struggle with this task. Difficulties may include aiming their drops,extending their neck, preventing excess drop leakage, avoiding contamination of the bottle tip and generating enough force to expel a drop from the bottle. Instillation aids are devices that aim to ameliorate one or more of these barriers.
Several eye drop dispensers had been developed in order to improved outcomes of eye drop instillation, including improved rates of successful administration and increased patient satisfaction compared to standard eye drop bottles.
In this study we aim to compare the eye drops various installation aids
Detailed description
subject will evaluate 2 dispensers by questioners. efficacy and safety of each one will be evaluated.
Study design
- Primary purpose
- Supportive care
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eye Drop Dispenser TYPE Opticare | Active comparator | Device: Eye Drop Dispenser TYPE Opticaresubject will assess TYPE 1 dispenser |
| Eye Drop Dispenser Autodrop | Active comparator | Device: Eye Drop Dispenser Autodropsubject will assess Autodrop dispenser |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- glaucoma patients
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eye Drop Dispenser TYPE OpticareSubject will apply normal saline eye drops to them-self with various eye drop dispensers. Assessment of ease of use will be conducted by questioners. | Device | Eye Drop Dispenser TYPE Opticare |
| Eye Drop Dispenser AutodropEye Drop Dispenser Autodrop | Device | Eye Drop Dispenser Autodrop |
Primary outcome
Number of correct application of eye drops to the eye without missing conducted by questioners.
Time frame: 5 seconds after instillation of eye drops
assessment of correct application of eye drops to the eye without missing
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Glaucoma
Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
Not yet recruiting
AI-Assisted vs Conventional Teleglaucoma Referral
Glaucoma
Recruiting
Brain Stimulation Effects on Orientation and Mobility Skills in Adults With Vision Impairment
Retinitis Pigmentosa (RP), Rod Cone Dystrophy
Recruiting
Automated Applanation Tonometry - Updated
Glaucoma, Glaucoma, Suspect
RecruitingPhase 2
A Phase 2a Study Comparing the Efficacy, Safety and Tolerability of Pregabalin Eye Drops Comparing With Timolol Eye Drops in Adults With Glaucoma or High Eye Pressure.
Primary Open - Angle Glaucoma (POAG), Ocular Hypertension (OHT)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eye Drop Dispenser TYPE Opticare and Eye Drop Dispenser Autodrop in people with Glaucoma and Cataract, run by Wolfson Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of correct application of eye drops to the eye without missing conducted by questioners. (time frame: 5 seconds after instillation of eye drops). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2018.