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Evaluate the TetraLens, a Tetracaine Releasing Therapeutic Bandage Contact Lens in Patients Undergoing PRK Procedure

NCT06085352 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-09-17

No results posted yet for this study

Summary

The goal of this clinical trial is to determine the safety, efficacy, and comfort of the investigational TetraLens bandage contact lens in patients who have undergone photorefractive keratectomy (PRK). The main question\[s\] it aims to answer are:

* Understand benefit of managing pain following the surgical procedure
* Understand the safety of the Tetralens Participants will be asked to wear theTetraLens BCL in one eye for 6 days post-operatively and: document the daily quantity of oral analgesics needed and report ocular pain and contact lens comfort.

Researchers will compare the study lens in one eye to a control lens in the contralateral (other eye)

Conditions

  • Ocular Pain

Interventions

DRUG

TetraLens bandage contact lens

Methafilcon-A contact lens eluding tetracaine ophthalmic solution

DEVICE

Control Acuvue Oasys Bandage contact Lens

Standard of care bandage contact lens

Sponsors & Collaborators

  • Vance Thompson Vision

    lead OTHER

Principal Investigators

  • Vance Thompson, MD · Vance Thompson Vision

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-06-26
Primary Completion
2023-12-31
Completion
2024-01-25
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06085352 on ClinicalTrials.gov