CTRI/2022/12/047937进行中（未招募）2 期
A Dose Escalating, Randomized, Phase 2b Study to Assess the Safety, Tolerability and Efficacy of Ocular Drug-Delivering Contact Lens LL-BMT1 in Subjects with Primary Open-Angle Glaucoma or Ocular Hypertension.
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 135
- 试验地点
- 4
- 主要终点
- To evaluate the ocular hypotensive efficacy of up to three doses of LL-BMT1 relative to timolol 0.5% and Bimatoprost ophthalmic solution 0.01% in subjects with POAG or OHT for up to 21 days.
研究概览
简要总结
This is a Dose Escalating, Randomized, Phase 2b Study to Assess the Safety, Tolerability and Efficacy of Ocular Drug-Delivering Contact Lens LL-BMT1 in Subjects with Primary Open-Angle Glaucoma or Ocular Hypertension.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects will be considered eligible for the study based on the following criteria:
- •Male or female subject of at least 18 years of age at the time of screening visit.
- •Diagnosed with POAG or OHT in both eyes.
- •At least one eye (called the study eye) must have an untreated IOP between 22 mmHg and 34 mmHg (both inclusive) as measured at 8 AM (± 1 hour) during the baseline visit.
- •For eyes receiving IOP treatment, untreated IOP will be assessed following a required washout period as outlined below: 4 days washout for parasympathomimetic and topical or systemic carbonic anhydrase inhibitors.
- •2 weeks washout for sympathomimetics and alpha agonists 4 weeks washout for beta adrenergic blocking agents, combination product, Rho kinase inhibitors, and prostaglandin agonists.
- •If the fellow eye does not meet inclusion criterion #3 above, it must have an untreated IOP (following washout, if applicable) within 5 mmHg of the study eye IOP without exceeding the 34 mmHg maximum (e.g., a study eye IOP of 22 mmHg and a fellow eye IOP of 17 mmHg is allowed).
- •BCVA of Early Treatment Diabetic Retinopathy Study (ETDRS) of 50 letters or better or BCVA of 20/100 or better on Snellen’s chart in each eye.
- •Female of child-bearing potential must not be pregnant or lactating, must have a negative urine pregnancy test at screening and must be practicing an adequate method of birth control, including intrauterine device (IUD); oral, dermal (“patchâ€), implant or injected contraceptives; tubal ligation; or barrier methods with spermicide.
- •No adverse reactions to nonmedicated contact lenses during the 2-week acclimation screening.
- •Score of 0-11 on CLDEQ-8 (Appendix-I), administered at the end of the 2-week acclimation screening
- •Willing and able to comply with the study procedure and sign a written informed consent.
排除标准
- •Subjects will be excluded from the study based on the following criteria:
- •Glaucoma or optic neuropathy due to anything other than POAG or OHT
- •Cup-to-disc ratio of >0.8 (horizontal or vertical measurements) in either eye in screening or baseline visit
- •Corneal thickness <480 or >620 Micro m
- •IOP >34 mmHg in either eye at the screening visit or baseline Visit
- •Significant visual field loss, in the opinion of the investigator
- •Any severe and uncontrolled comorbid medical conditions which, in the opinion of the investigator, may either put the subject at risk because of participation in the study or may influence the results of the study, or the subject’s ability to participate in the study.
- •Current contact lens use for vision correction/ cosmetic purposes (unless willing to switch to glasses for the duration of the study)
- •Subject with current or a last 3-month history of severe dry eye in either eye
- •Subjects with meibomian gland dysfunction.
- •History of treated allergic, vernal, or atopic conjunctivitis
- •History of contact lens intolerance, corneal scarring, corneal neovascularization, giant papillary conjunctivitis, or any other corneal pathology that is deemed by the investigator to constitute a contraindication for applying contact lenses
- •Aphakia or presence of anterior chamber intraocular lens in either eye
- •History of clinically significant macular pathology (i.e., progressive age-related macular degeneration, diabetic macular edema, proliferative diabetic retinopathy, etc.) in either eye.
- •History of corneal refractive surgery (i.e., laser-assisted in situ keratomileusis [LASIK], photorefractive keratectomy [PRK], radial keratotomy [RK], small incision lenticule extraction [SMILE], or corneal inlay, etc.) in either eye.
- •History of prior incisional glaucoma surgery (i.e., bleb, shunt, seton, etc.) in either eye.
- •History within past 6 months of any ocular anterior segment laser or other intraocular surgery in either eye
- •Use of laser of any type on retina in either eye within 3 months prior to the screening visit.
- •History of punctal cautery or planned use of punctal plugs during the study in either eye.
- •Cataract surgery in either eye within 3 months, or other intraocular surgery in either eye within 6 months prior to the Screening Visit or planned during the course of the study.
- •Required chronic use of topical or injectable ocular medications other than IOP-lowering medication, including artificial tears, or currently receiving chronic intravitreal injections.
- •Subjects with bronchial asthma, a history of bronchial asthma, severe chronic obstructive pulmonary disease, sinus bradycardia, second or third degree atrioventricular block, or cardiac failure, overactive thyroid gland, myasthenia gravis.
- •Congestive heart failure (New York Heart Association [NYHA] class III & class IV), angina, myocardial infarction, cerebrovascular accident, coronary/peripheral artery bypass graft surgery, transient ischemic attack, deep vein thrombosis (DVT), heart failure, Pulmonary Thromboembolism (PTE) or pulmonary embolism or any other established major cardiovascular disease prior to screening.
- •Known allergy or hypersensitivity to the IP or its components
- •Treatment with an investigational product or/ participation in a clinical trial within 30 days prior to the screening visit.
- •Employee of the sponsor, investigator, or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees of sponsor or the investigator.
结局指标
主要结局
To evaluate the ocular hypotensive efficacy of up to three doses of LL-BMT1 relative to timolol 0.5% and Bimatoprost ophthalmic solution 0.01% in subjects with POAG or OHT for up to 21 days.
时间窗: 21 Days.
次要结局
- To evaluate the ocular safety and tolerability of up to three doses of LL-BMT1 for up to 21 days(21 Days.)
研究者
研究点 (4)
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