Tolerability of an Anesthesia-free Tonometer Tip

NCT06585423 | Completed FDA Device

• 2 other identifiers: Pro00115919399000397
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Glaucoma

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline

Study Arms (5)

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

Interventions

Sterile commercially available bandage contact lens DIAGNOSTIC_TEST

Medical grade acrylic tip covered by a sterile commercially available bandage contact lens

Medical grade acrylic tip covered by a sterile commercially available bandage contact lens

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 acrylic tip coated with medical grade silicone of a thickness > 100 µm

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 blur tint

Medical grade acrylic tip coated with medical grade silicone of a thickness < 100 µm with blue tint

Standard tip in conjunction with a topical anesthetic DIAGNOSTIC_TEST

Standard tip in conjunction with a topical anesthetic

Standard tip in conjunction with a topical anesthetic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Presenting for a routine eye exam
• ≥ 18 years of age
• Able and willing to give consent

You may not qualify if:

• History of corneal scarring
• Active infection of the eye
• History of alternated corneal sensitivity
• History of corneal surgery

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke Eye Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Officials

• Joanne Wen, MD

  Duke Eye Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: September 3, 2024
• First Posted: September 5, 2024
• Study Start: October 17, 2024
• Primary Completion: February 25, 2026
• Study Completion: February 25, 2026
• Last Updated: June 9, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)