A Single Center, Randomized, Contralateral, 6 Month Study to Evaluate the Safety, Analgesic Efficacy of ACUVAIL™ (Ketorolac Tromethamine Ophthalmic Solution) 0.45%, in Post-PRK Corneal Wound Healing
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Time to re-epithelialization
研究概览
简要总结
STUDY OBJECTIVE: To evaluate the safety and efficacy of Acuvail 0.45% administered BID for increasing corneal re-epithelialization, decreasing the time to zero pain in post-photorefractive keratectomy (PRK) surgery, and PRK enhancement assessment at 6 months post op
CLINICAL HYPOTHESES: Acuvail 0.45% administered twice daily is superior to Systane Ultra lubricant in treating post PRK pain
OVERAL STUDY DESIGN:
Structure: Single-center, randomized, open label, contralateral (one eye receives Acuvail, one eye Systane Ultra)
Treatment Group: Patients will be randomized to the eye that will receive Acuvail 0.45% Assignment: Acuvail 0.45% in one eye, Systane Ultra in contralateral eye
Duration: 6.5 months
Controls: Systane Ultra preservative-free lubricant
Dosage/Dose Regimen: Study medication will be administered to the randomized eye through post op days 1-2 BID
Visit Schedule: Screening (baseline), Day 2-30 (Surgery), post surgery Day 1 and each day through corneal re-epithelialization, post surgery months 1, 3, and 6.
Number of Patients: 10 (20 eyes)
Condition/Disease: patients undergoing bilateral PRK surgery
详细描述
- INTRODUCTION
Laser Vision Correction is one of the most commonly performed elective procedures in the United States. Although the Laser in situ keratomileusis (LASIK) is the more popular vision correction procedure, a growing number of surgeons have switched to surface ablation techniques, including PRK, LASEK, and Epi-LASIK. In surface laser procedures, the epithelium (clear outer skin of the cornea) is removed, prior to laser reshaping of the cornea. This creates an epithelial defect that can take 3-6 days for the epithelium to regenerate. During this healing process, patients often report moderate to severe ocular pain.
A variety of treatments have been utilized to reduce postoperative pain. Placement of a contact lens on the eye immediate post PRK, has been shown to reduce patient discomfort as well as topical dilute tetracaine, oral medications, and even prednisone has been recommended as treatment options for pain control. Another method that has been shown in a number of studies to assist with the reduction of post operative pain is topical non steroidal anti inflammatory drops.
Pain management following PRK surgery has been minimized by more advanced surgical techniques, antibiotics, and pre- or post-operative use of topical NSAID solutions. We will compare the use of Acuvail 0.45% administered twice daily to Systane Ultra in treating post PRK pain. 2. STUDY OBJECTIVE
To evaluate the safety and efficacy of Acuvail 0.45% administered BID for increasing re-epithelialization time, decreasing the time to zero pain in post-photorefractive keratectomy (PRK) surgery and assessment of PRK enhancement needs at 6 months post op.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 39 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female patients, 18-39 yrs of age, in good general health
- •Patient is schedule to undergo bilateral PRK surgery
- •The difference between the two eyes ≤ 2 D
- •Refractive error -1 to -8 diopters (spherical equivalent) at baseline
- •Females of childbearing potiential must have a negative pregnancy test result at baseline. A female considered to be of non-childbearing potential is she is postmenopausal (no menses for 12 consecutive months) or is without a uterus.
- •Ability to follow study instructions and likely to complete the entire course of the study
- •Written informed consent has been obtained
- •Written HIPPA authorization has been obtained
排除标准
- •Uncontrolled systemic disease
- •Any active ocular disease, corneal abnormalities, lid abnormalities, or any ocular pathologies
- •History of serious eye disease, trauma, or previous ocular surgery
- •History of unstable myopia
- •History of herpes keratitis
- •Known allergy or hypersensitivity to the study medication
- •Anticipated wearing of contact lenses in addition to the required bandage contact lens post-PRK. Patients who wear soft contact lenses should discontinue wearing them at least 3 days prior to baseline visit. Patients wearing RGP or hard contact lenses should discontinue wearing them at least 3 weeks prior to baseline visit.
- •Females who are pregnant, breastfeeding, or trying to conceive.
- •Keratoconus or keratoconus suspect
- •Concurrent participation in an investigational drug study or participation within 30 days prior to study start
- •Any condition or situation which, in the investigator's opinion, may put patient at significant risk or may confound the study results
结局指标
主要结局
Time to re-epithelialization
时间窗: 3-7 days
Amount of days it takes for the cornea to re-epithelialize after PRK surgery, will be documented for each eye separately.
次要结局
- Time to zero pain(3-7 days)
- Occurence of enhancments(6 months post operative)
研究者
Daniel S. Durrie, MD
Presidenet
Durrie Vision