A Multicenter, Open-Label Study to Evaluate Perioperative Treatment of Dry Eye With Miebo® in Subjects Undergoing LASIK

Обзор

Compare eye dryness following laser-assisted in situ keratomileusis (LASIK) surgery to eye dryness prior to receiving perioperative Miebo in patients with dry eye disease (DED)

Вмешательства

• Препарат Miebo four times per day
  Single arm study where subjects dose with Miebo four times per day for one month before LASIK and for 1.5 months after LASIK

Первичные конечные точки

• Compare eye dryness following laser-assisted in situ keratomileusis (LASIK) surgery to eye dryness prior to receiving perioperative Miebo in patients with dry eye disease (DED) as measured by visual analog scale (VAS) eye dryness score [Срок оценки: 4 months]

Критерии участия

Критерии включения

• Be at least 18 years of age at the time of consent, able to provide written voluntary informed consent, willing to follow instructions and participate in all trial assessments and visits
• Be a candidate for routine, uncomplicated bilateral LASIK surgery (for spherical equivalent \[≤-8.00D\] myopia or myopic astigmatism correction, not combined with any other procedure; monovision myopic targets are allowed, however the myopic target eye will be the non-study \[fellow\] eye)
• No history of refractive surgery including implantable Collamer lens (ICL) or cataract surgery
• Total CFS score ≥1 and ≤6 using the National Eye Institute scale at Visit 1 (in at least one eye)
• Ocular Surface Disease Index (OSDI) ≥13 and ≤22 at Visit 1

Критерии исключения

• Have any clinically significant ocular surface slit-lamp findings in the study eye that, in the opinion of the Investigator, could interfere with outcomes of a routine, uncomplicated LASIK surgery, including but not limited to:

• History of eye trauma/surgery within the last 6 months that resulted in corneal scarring
• DED secondary to scarring, irradiation, alkali burns, cicatricial pemphigoid, or destruction of conjunctival goblet cells, Stevens-Johnson syndrome, active blepharitis, or lid margin inflammation
• Abnormal cornea (e.g., keratoconus or corneal epithelial defect, pterygium, or history of herpetic keratitis)
• Use of any of the following ocular therapies in the study eye within 30 days prior to Visit 1: topical ocular steroid treatments, prescription dry eye therapy (including nasal spray), or topical intraocular pressure-lowering medications
• Use of any eye drops (prescription or over the counter) in the study eye within 24 hours prior to Visit 1
• Use of any oral medications known to cause ocular drying (e.g., antihistamines, antidepressants, etc.) on a non-stable regimen within 1 month prior to Visit 1 or is expected to be unstable during the trial
• Had a LipiFlow®, intense pulsed light (IPL) therapy, etc. in the study eye within 3 months prior to Visit 1
• Had received or removed a permanent punctum plug in the study eye within 1 month (3 months for dissolvable punctum plugs) prior to Visit 1
• Have worn soft contact lenses within either 3 days prior to the study or rigid gas-permeable contact lenses for 1 month prior to Visit 1 or any planned wear during the study
• Have undergone intraocular surgery or ocular laser surgery in the study eye within 3 months prior to Visit 1
• Have ocular allergies that are/expected to be active during the trial period
• Have active ocular or systemic infection (bacterial, viral, or fungal), including fever
• Have any ocular findings or uncontrolled systemic disease that, in the opinion of the Investigator, will interfere with the trial
• Female subjects who are pregnant, nursing, or planning a pregnancy
• Female subjects of childbearing potential who are not using an acceptable means of birth control; acceptable methods of contraception include hormonal (oral, implantable, injectable, or transdermal) contraception; mechanical (spermicide in conjunction with a barrier such as a diaphragm or condom) contraception; intrauterine device; or surgical sterilization of partner. For non-sexually active female subjects, abstinence may be regarded as an adequate method of birth control; however, if the subject becomes sexually active during the trial, she must agree to use adequate birth control as defined above for the remainder of the trial.
• Have a known allergy and/or sensitivity or lack of desired efficacy in response to the investigational drug
• Are currently enrolled in an investigational drug or device study or had used an investigational drug or device within 30 days prior to Visit 1 -

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 4 центра

• Vance Thompson Vision- Bozeman — Bozeman
• Vance Thompson Vision- Omaha — Omaha
• Vance Thompson Vision- Fargo — Fargo
• Vance Thompson Vision- Sioux Falls — Sioux Falls

Идентификаторы

NCT: NCT07650708 · BL-RX01-SONORAN-1401

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗