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, and Wearability Using the TetraLens, a Tetracaine Releasing Therapeutic Bandage Contact Lens in Patients Undergoing a Photorefractive Keratotomy Procedures (PRK)

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)

Study Overview

• Status: Recruiting
• Conditions: Ocular Pain Following Bilateral Photorefractive Keratotomy (PRK)
• Intervention / Treatment: Drug: TetraLens bandage contact lens; Device: Control Acuvue Oasys Bandage contact Lens

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.

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Kristin Dunne; Phone Number: 605-371-7037; Email: kristin.dunne@vancethompsonvision.com
• Study Contact Backup: Name: Elle Malmanger; Phone Number: 605-371-7083; Email: elle.malmanger@vancethompsonvision.com

Study Locations

• United States
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57108
      • Recruiting
      • Vance Thompson Vision
      • Sub-Investigator: Kayla Karpuk, OD
      • Contact: Keeley Puls; Phone Number: 605-371-7075; Email: keeley.puls@vancethompsonvision.com
      • Contact: Kristin Dunne; Phone Number: 6053613937; Email: kristin.dunne@vancethompsonvision.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Patients ≥ 22 years of age at time of surgery
2. patients who have been cleared to undergo PRK procedure
3. 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
4. Patients are able to wear bandage contact lens for 1 week
5. Patients able to attend all follow-up study visits

Exclusion Criteria:

1. Patients who have experienced complications during PRK procedures

2. Women of childbearing potential that are pregnant, nursing, or planning a pregnancy, and are not using effective methods of contraception. Effective contraception methods include:

   1. 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).
   2. 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
   3. 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
   4. Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository
   5. 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
   6. Placement of an intrauterine device (IUD) or intrauterine system (IUS).
3. Known allergy to Tetracaine or contraindications for its use
4. Significant anisometropia of greater than 2 diopters of manifest refraction spherical equivalent (MRSE) between eyes or hyperopes
5. Subjects having a history of previous eye surgery
6. Subjects with planned MRSE treatment of greater than 6.00D
7. Subjects with uncontrolled dry eye disease in the opinion of the investigator
8. 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
9. 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
10. Use of chronic glaucoma and or hypotensive topical medications than in the view of the investigator could cause epitheliopathy and affect the rate of re-epithelization
11. Visually significant cataract
12. Other pathology of the cornea or anterior segment including lagophthalmos, blepharitis, anterior membrane dystrophy, corneal neuropathy, recurrent erosions and/or scarring that would affect wound re-epithelization
13. Use of medications that may affect and/or decrease the rate of corneal healing [e.g., systemic and or topical medications (corticosteroids, antimetabolites such as mitomycin) and/or antiviral medications] and or recent use (within the past 6 months) of isotretinoin, amiodarone or any medications that can affect corneal integrity
14. Any other factors that in the opinion of the investigator could put the subject at safety risk

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Receive Investigational TetraLens BCL; At random, one eye will receive the contact lens that contains the tetracaine HCL	Drug: TetraLens bandage contact lens; Methafilcon-A contact lens eluding tetracaine ophthalmic solution
Sham Comparator: Receive standard bandage contact lens; At random, one eye will receive the standard of care bandage contact lens	Device: Control Acuvue Oasys Bandage contact Lens; Standard of care bandage contact lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess the 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 with respect to adverse reactions	Cumulative rate of adverse reactions and time to corneal wound healing (re-epithelization)	6 days post-operative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exploratory efficacy of Tetralens BCL management of pain and contact lens tolerability	Evaluate reported pain using Ocular Pain Assessment Survey, evaluate contact lens comfort and awareness	Cumulatively for 6 days post-operative
Safety of Tetralens BCL	Assess safety of TetraLens BCL using exploratory measures of rate of adverse events, corneal thickness, slit-lamp evaluation, rate of contact lens related deficiencies	Cumulative 6 days post-operative

Collaborators and Investigators

• Sponsor: Vance Thompson Vision
• Investigators: Principal Investigator: Vance Thompson, MD, Vance Thompson Vision

Study record dates

Study Major Dates

• Study Start (Actual): June 26, 2023
• Primary Completion (Estimated): January 31, 2024
• Study Completion (Estimated): February 25, 2024

Study Registration Dates

• First Submitted: September 26, 2023
• First Submitted That Met QC Criteria: October 12, 2023
• First Posted (Actual): October 16, 2023

Study Record Updates

• Last Update Posted (Actual): October 16, 2023
• Last Update Submitted That Met QC Criteria: October 12, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: ocular pain
• Additional Relevant MeSH Terms: Eye Diseases; Pain; Neurologic Manifestations; Eye Manifestations; Eye Pain
• Other Study ID Numbers: USPFOS-01

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: Yes
• Studies a U.S. FDA-regulated device product: No