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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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Ocular Pain Following Bilateral Photorefractive Keratotomy (PRK)

Intervention / Treatment
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* Drug: TetraLens bandage contact lens
* Device: Control Acuvue Oasys Bandage contact Lens


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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 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 Visually significant cataract 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 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 Any other factors that in the opinion of the investigator could put the subject at safety risk

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ocular pain