Status:
COMPLETED
Evaluate the TetraLens, a Tetracaine Releasing Therapeutic Bandage Contact Lens in Patients Undergoing PRK Procedure
Lead Sponsor:
Vance Thompson Vision
Conditions:
Ocular Pain
Eligibility:
All Genders
22+ years
Phase:
EARLY_PHASE1
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)...
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 asses...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 26 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 25 2024
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06085352
Start Date
June 26 2023
End Date
January 25 2024
Last Update
September 17 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Vance Thompson Vision
Sioux Falls, South Dakota, United States, 57108