NCT06085352已完成早期 1 期
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)
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Efficacy of TetraLens BCL in the management of pain following surgical procedures
研究概览
简要总结
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)
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Receive Investigational TetraLens BCL
Experimental
At random, one eye will receive the contact lens that contains the tetracaine HCL
干预措施: TetraLens bandage contact lens (Drug)
Receive standard bandage contact lens
Sham Comparator
At random, one eye will receive the standard of care bandage contact lens
干预措施: Control Acuvue Oasys Bandage contact Lens (Device)
结局指标
主要结局
Efficacy of TetraLens BCL in the management of pain following surgical procedures
时间窗: 6 days post-operative
Cumulative number of daily pain medications up to Day 6 post-operative
Safety of TetraLens BCL
时间窗: 6 days post-operative
Corneal wound healing (re-epithelization)
次要结局
未报告次要终点
研究者
研究点 (1)
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