Tolerability of an Anesthesia-free Tonometer Tip

December 19, 2025 updated by: Duke University
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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Medical grade acrylic tip covered by a sterile commercially available bandage contact lens
Diagnostic test: Sterile commercially available bandage contact lens
Medical grade acrylic tip covered by a sterile commercially available bandage contact lens
Experimental: Medical grade acrylic tip coated with medical grade silicone of a thickness < 100 µm
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: Medical grade acrylic tip coated with medical grade silicone of a thickness > 100 µm
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: Medical grade acrylic tip coated with medical grade silicone of a thickness < 100 µm with blue tint
Diagnostic test: 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 blur tint
Active Comparator: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline
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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Investigators

  • Principal Investigator: Joanne Wen, MD, Duke Eye Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 17, 2024

Primary Completion (Estimated)

March 2, 2026

Study Completion (Estimated)

March 2, 2026

Study Registration Dates

First Submitted

September 3, 2024

First Submitted That Met QC Criteria

September 3, 2024

First Posted (Actual)

September 5, 2024

Study Record Updates

Last Update Posted (Actual)

December 23, 2025

Last Update Submitted That Met QC Criteria

December 19, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00115919
  • 399000397 (Other Grant/Funding Number: Gilhuly Accelerator Fund)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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