GlaucomaNCT06585423
Tolerability of an Anesthesia-free Tonometer Tip
A study testing Sterile commercially available bandage contact lens, Medical grade silicone of a thickness <100 µm and Medical grade silicone of a thickness >100 µm in people with Glaucoma, run by Duke University at 1 site in United States.
Trial summary
The purpose of this study is to compare the tolerability and comfort of 4 different prototype anesthesia-free tonometer tips with the standard tonometer tip in conjunction with anesthesia. The best-tolerated prototype anesthesia-free tonometer tip will be identified for further development for home tonometry. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma
- What is being tested?
- Sterile commercially available bandage contact lens, Medical grade silicone of a thickness <100 µm and Medical grade silicone of a thickness >100 µm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Oct 2024to 25 Feb 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presenting for a routine eye exam
- ≥ 18 years of age
- Able and willing to give consent
Who cannot join
- History of corneal scarring
- Active infection of the eye
- History of alternated corneal sensitivity
- History of corneal surgery
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to compare the tolerability and comfort of 4 different prototype anesthesia-free tonometer tips with the standard tonometer tip in conjunction with anesthesia. The best-tolerated prototype anesthesia-free tonometer tip will be identified for further development for home tonometry.
- Conditions
- Glaucoma
- Being tested
- Sterile commercially available bandage contact lens, Medical grade silicone of a thickness <100 µm, Medical grade silicone of a thickness >100 µm, Medical grade silicone of a thickness <100 µm with blur tint, Standard tip in conjunction with a topical anesthetic
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sterile commercially available bandage contact lensDiagnostic test
Medical grade acrylic tip covered by a sterile commercially available bandage contact lens
Medical grade silicone of a thickness <100 µmDiagnostic test
Medical grade acrylic tip coated with medical grade silicone of a thickness <100 µm
Medical grade silicone of a thickness >100 µmDiagnostic test
Medical grade acrylic tip coated with medical grade silicone of a thickness >100 µm
Medical grade silicone of a thickness <100 µm with blur tintDiagnostic test
Medical grade acrylic tip coated with medical grade silicone of a thickness <100 µm with blur tint
Standard tip in conjunction with a topical anestheticDiagnostic test
Standard tip in conjunction with a topical anesthetic
| Study group | Role | What they receive |
|---|---|---|
| Medical grade acrylic tip covered by a sterile commercially available bandage contact lens | Experimental | Not described Receives: Diagnostic Test: Sterile commercially available bandage contact lens |
| Medical grade acrylic tip coated with medical grade silicone of a thickness < 100 µm | Experimental | Not described Receives: Diagnostic Test: Medical grade silicone of a thickness <100 µm |
| Medical grade acrylic tip coated with medical grade silicone of a thickness > 100 µm | Experimental | Not described Receives: Diagnostic Test: Medical grade silicone of a thickness >100 µm |
| Medical grade acrylic tip coated with medical grade silicone of a thickness < 100 µm with blue tint | Experimental | Not described Receives: Diagnostic Test: Medical grade silicone of a thickness <100 µm with blur tint |
| Standard tip in conjunction with a topical anesthetic | Active comparator | Not described Receives: Diagnostic Test: Standard tip in conjunction with a topical anesthetic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient tolerability rating of different tips
Tolerability of the different prototype anesthesia-free tonometer tips with the standard tonometer tip - based on a 0-5 scale the participants reports with higher score meaning more comfortable.
Measured: Baseline
Patient comfort rating of different tips
Comfort of the different prototype anesthesia-free tonometer tips with the standard tonometer tip - based on a 0-5 scale the participants reports with higher score meaning more comfortable.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2024
- Study start17 Oct 2024
- Primary completion25 Feb 2026
- Study completion25 Feb 2026
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.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intraocular pressure measurements using 4 different prototype tips. All standard equipment used to perform Goldmann Applanation Tonometry will be used with the only difference being the applanator tip. The 4 prototypes are as follows and are tested in random order: 1. \- Medical grade acrylic tip covered by a sterile commercially available bandage contact lens (Air Optix, Night and Day Contacts, Alcon). The bandage contact lens will be changed between subjects and the underlying acrylic tip sterilized per standard clinical procedure (bleach soak followed by soak and rinse in sterile water). 2. \- Medical grade acrylic tip coated with medical grade silicone of a thickness \< 100 µm. T 3. \- Medical grade acrylic tip coated with medical grade silicone of a thickness \> 100 µm. 4. \- Medical grade acrylic tip coated with medical grade silicone of a thickness \< 100 µm with blur tint. All tips will be sterilized between subjects 5. \- Standard tip in conjunction with a topical anesthetic
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joanne Wen, MD, Principal investigator, Duke Eye Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06585423
- Sponsor's protocol ID
- Pro00115919
- Other IDs
- 399000397
- Status last verified
- Nov 2026
- First submitted
- 3 Sep 2024
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tolerability of an Anesthesia-free Tonometer Tip
- ClinicalTrials.gov ID
- NCT06585423
- Acronym / sponsor ID
- Pro00115919
- Conditions
- Glaucoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 17 Oct 2024 (actual)
- Primary completion
- 25 Feb 2026 (actual)
- Study completion
- 25 Feb 2026 (actual)
- First posted
- 5 Sep 2024 (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.
The purpose of this study is to compare the tolerability and comfort of 4 different prototype anesthesia-free tonometer tips with the standard tonometer tip in conjunction with anesthesia. The best-tolerated prototype anesthesia-free tonometer tip will be identified for further development for home tonometry.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- Intraocular pressure measurements using 4 different prototype tips. All standard equipment used to perform Goldmann Applanation Tonometry will be used with the only difference being the applanator tip. The 4 prototypes are as follows and are tested in random order: 1. - Medical grade acrylic tip covered by a sterile commercially available bandage contact lens (Air Optix, Night and Day Contacts, Alcon). The bandage contact lens will be changed between subjects and the underlying acrylic tip sterilized per standard clinical procedure (bleach soak followed by soak and rinse in sterile water). 2. - Medical grade acrylic tip coated with medical grade silicone of a thickness < 100 µm. T 3. - Medical grade acrylic tip coated with medical grade silicone of a thickness > 100 µm. 4. - Medical grade acrylic tip coated with medical grade silicone of a thickness < 100 µm with blur tint. All tips will be sterilized between subjects 5. - Standard tip in conjunction with a topical anesthetic
| Arm | Type | Receives |
|---|---|---|
| Medical grade acrylic tip covered by a sterile commercially available bandage contact lens | Experimental | Diagnostic Test: Sterile commercially available bandage contact lens |
| Medical grade acrylic tip coated with medical grade silicone of a thickness < 100 µm | Experimental | Diagnostic Test: Medical grade silicone of a thickness <100 µm |
| Medical grade acrylic tip coated with medical grade silicone of a thickness > 100 µm | Experimental | Diagnostic Test: Medical grade silicone of a thickness >100 µm |
| Medical grade acrylic tip coated with medical grade silicone of a thickness < 100 µm with blue tint | Experimental | Diagnostic Test: Medical grade silicone of a thickness <100 µm with blur tint |
| Standard tip in conjunction with a topical anesthetic | Active comparator | Diagnostic Test: Standard tip in conjunction with a topical anesthetic |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Presenting for a routine eye exam
- ≥ 18 years of age
- Able and willing to give consent
Key exclusion criteria (4 listed)
- History of corneal scarring
- Active infection of the eye
- History of alternated corneal sensitivity
- History of corneal surgery
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 |
|---|---|---|
| Sterile commercially available bandage contact lensMedical grade acrylic tip covered by a sterile commercially available bandage contact lens | Diagnostic test | Medical grade acrylic tip covered by a sterile commercially available bandage contact lens |
| Medical grade silicone of a thickness <100 µmMedical grade acrylic tip coated with medical grade silicone of a thickness <100 µm | Diagnostic test | Medical grade acrylic tip coated with medical grade silicone of a thickness < 100 µm |
| Medical grade silicone of a thickness >100 µmMedical grade acrylic tip coated with medical grade silicone of a thickness >100 µm | Diagnostic test | Medical grade acrylic tip coated with medical grade silicone of a thickness > 100 µm |
| Medical grade silicone of a thickness <100 µm with blur tintMedical grade acrylic tip coated with medical grade silicone of a thickness <100 µm with blur tint | Diagnostic test | Medical grade acrylic tip coated with medical grade silicone of a thickness < 100 µm with blue tint |
| Standard tip in conjunction with a topical anestheticStandard tip in conjunction with a topical anesthetic | Diagnostic test | Standard tip in conjunction with a topical anesthetic |
Primary outcome
Patient tolerability rating of different tips
Time frame: Baseline
Tolerability of the different prototype anesthesia-free tonometer tips with the standard tonometer tip - based on a 0-5 scale the participants reports with higher score meaning more comfortable.
Patient comfort rating of different tips
Time frame: Baseline
Comfort of the different prototype anesthesia-free tonometer tips with the standard tonometer tip - based on a 0-5 scale the participants reports with higher score meaning more comfortable.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: No
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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.
Joanne Wen, MD principal investigator
Duke Eye Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sterile commercially available bandage contact lens, Medical grade silicone of a thickness <100 µm and Medical grade silicone of a thickness >100 µm in people with Glaucoma, run by Duke University at 1 site in United States.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 4 Nov 2026. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient tolerability rating of different tips (time frame: Baseline). The study lists 2 primary outcomes in all. 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 4 Nov 2026.