NCT06085352

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

An Investigator Initiated, Randomized, Single Center Clinical Study to Evaluate the Safety, Efficacy Using the TetraLens, a Tetracaine Releasing Therapeutic Bandage Contact Lens Undergoing a Photorefractive Keratotomy Procedure (PRK)

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Vance Thompson Vision · Academic / Other
• Sex: All
• Age: 22 Years
• Healthy volunteers: Accepted

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)

Detailed description

The safety and efficacy of the methafilcon A and tetracaine HCL components of the TetraLens BCL have safety and efficacy profiles that are well established. This study aims to obtain the initial assessment of the safety efficacy and wearability of the TetraLens BCL for use a therapeutic bandage contact lens for short-term topical pain relief following ocular surgery.

Conditions

• Ocular Pain

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-06-26
• Primary completion: 2023-12-31
• Completion: 2024-01-25
• First posted: 2023-10-16
• Last updated: 2025-09-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study