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

NCT06085352 | Completed Early Phase 1 FDA Drug

• 1 other identifier: USPFOS-01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

ocular pain

Outcome Measures

Primary Outcomes (2)

• Efficacy of TetraLens BCL in the management of pain following surgical procedures

  Cumulative number of daily pain medications up to Day 6 post-operative

  6 days post-operative

• Safety of TetraLens BCL

  Corneal wound healing (re-epithelization)

  6 days post-operative

Study Arms (2)

Receive Investigational TetraLens BCL

EXPERIMENTAL

At random, one eye will receive the contact lens that contains the tetracaine HCL

Drug: TetraLens bandage contact lens

Receive standard bandage contact lens

SHAM COMPARATOR

At random, one eye will receive the standard of care bandage contact lens

Device: Control Acuvue Oasys Bandage contact Lens

Interventions

TetraLens bandage contact lens DRUG

Methafilcon-A contact lens eluding tetracaine ophthalmic solution

Receive Investigational TetraLens BCL

Control Acuvue Oasys Bandage contact Lens DEVICE

Standard of care bandage contact lens

Receive standard bandage contact lens

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients ≥ 22 years of age at time of surgery
• patients who have been cleared to undergo PRK procedure
• Patients who are willing to have procedure in both eyes, at least 1 week apart randomized to receive the product under investigation in one eye and control lens in other eye
• Patients are able to wear bandage contact lens for 1 week
• Patients able to attend all follow-up study visits

You may not qualify if:

• Patients who have experienced complications during PRK procedures
• Women of childbearing potential that are pregnant, nursing, or planning a pregnancy, and are not using effective methods of contraception. Effective contraception methods include:
• Total abstinence (when this is in line with the preferred and usual lifestyle of the subject). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post ovulation methods) and withdrawal are not acceptable methods of contraception. (Occasional abstinence is not an effective contraceptive method).
• Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least 6 weeks before Baseline. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment
• Male sterilization (at least 6 months prior to Baseline). For female subjects in the study, the vasectomized male partner should be the sole partner for that subject
• Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository
• Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate \< 1%), for example hormone vaginal ring or transdermal hormone contraception
• Placement of an intrauterine device (IUD) or intrauterine system (IUS).
• Known allergy to Tetracaine or contraindications for its use
• Significant anisometropia of greater than 2 diopters of manifest refraction spherical equivalent (MRSE) between eyes or hyperopes
• Subjects having a history of previous eye surgery
• Subjects with planned MRSE treatment of greater than 6.00D
• Subjects with uncontrolled dry eye disease in the opinion of the investigator
• History of systemic disorder such as diabetes, connective tissue disorder (systemic lupus erythematosis, rheumatoid arthritis, Sjögren syndrome, mucous membrane pemphigoid), thyroid disease, or immunosuppressive disorders (Human Immunodeficiency Virus \[HIV\], long-term steroid use, transplant recipient), that may affect post-operative healing
• Corneal disease that may affect outcomes including keratoconus, form fruste keratoconus, limbal stem cell deficiency, pellucid marginal degeneration, contact lens warpage, and/or herpes keratitis

Sponsors & Collaborators

• Vance Thompson Vision: lead

Study Sites (1)

Vance Thompson Vision

Sioux Falls, South Dakota, 57108, United States

Location

MeSH Terms

Conditions

Eye Pain

Condition Hierarchy (Ancestors)

Eye Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations

Study Officials

• Vance Thompson, MD

  Vance Thompson Vision

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2023
• First Posted: October 16, 2023
• Study Start: June 26, 2023
• Primary Completion: December 31, 2023
• Study Completion: January 25, 2024
• Last Updated: September 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)