ACTRN12612000145808撤回未知
A prospective, randomised validation of corneal epithelial cell-counting with two instruments after 4 hours of bilateral contact lens wear and a prospective, randomised, masked, parallel group comparison of two commercially-available tear supplements utilising different preservatives, on corneal epithelial cell shedding when tear supplements are used unilaterally for two weeks
适应症
试验速览
- 阶段
- 未知
- 状态
- 撤回
- 入组人数
- 25
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Diagnosis
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent.
- •-Be at least 18 years old, male or female.
- •-Willing to comply with the wearing and clinical trial visit schedule as directed by the Investigator.
- •-Have ocular health findings considered to be normal” and which would not prevent the participant from safely wearing contact lenses.
- •-Be an experienced contact lens wearer (but willing to not wear contact lenses for the duration of the trial, except, during stage visits 2-3) or a non lens wearer (but willing to wear plano lenses for approximately four hours on one day during stage 1 visits 2-3).
排除标准
- •-Any pre-existing ocular irritation, injury or condition (including infection or disease) of the cornea, conjunctiva or eyelids that would preclude contact lens fitting and safe wearing of contact lenses.
- •-Any systemic disease that adversely affects ocular health e.g. diabetes, Graves disease, and auto immune diseases such as ankylosing spondylitis, multiple sclerosis, Sjögrens syndrome and systemic lupus erythematosus. Conditions such as systemic hypertension and arthritis do not automatically exclude prospective participants.
- •-Use of or a need for concurrent category S3 and above ocular medication at enrolment and/or during the clinical trial.
- •-Use of or a need for any systemic medication or topical medications which may alter normal ocular findings / are known to affect a participant’s ocular health / physiology or contact lens performance either in an adverse or beneficial manner at enrolment and/or during the clinical trial.
- •NB: Systemic antihistamines are allowed on an as needed basis”, provided they are not used prophylactically during the trial and at least 24 hours before the clinical trial product is used.
- •-Eye surgery within 12 weeks immediately prior to enrolment for this trial.
- •-Previous corneal refractive surgery.
- •-Known allergy or intolerance to ingredients in any of the clinical trial products.
- •-Currently enrolled in another clinical trial.
- •-Participation in a clinical trial within the previous 2 weeks for dispensing studies and 48 hours between in-house studies.
- •-Not willing to not wear contact lenses for the duration of the clinical trial.
- •-Pregnancy* (either at enrolment or during the course of the trial). Formal testing of pregnancy is not required. A participant’s verbal report is sufficient
- •-The Investigator may, at his / her discretion, exclude anyone who they believe may not be able to fulfil the clinical trial requirements or it is believed to be in the participant’s best interests.
研究者
相似试验
进行中（未招募）
Unknown
Assessing corneal integrity in healthy eyes and eyes after laser refractive surgeryPost-LASIKCorneal nerve functionEye - Diseases / disorders of the eyeEye - Normal eye development and functionACTRN12623000830695The University of Melbourne29
尚未招募
Unknown
A randomized comparative study of the Active Sentry handpiece versus the Ozil handpiece in phacoemulsificatioCorneal endothelial cell lossSurgery - Other surgeryEye - Diseases / disorders of the eyeCataractACTRN12624000425594RSSM Medical trading as Derwent Eye Specialists84
已完成
不适用
Evaluation for therapeutic effect of corneal photovetrification against macular degeneratioDry type age-related macular degeneration, wet type age-related macular degeneration, and myopic macular degenerationJPRN-UMIN000019629Minami Aoyama Eye Clinic15
进行中（未招募）
不适用
A Randomised, Clinical Trial of Corneal Collagen Cross-Linking in KeratoconusEye - Diseases / disorders of the eyekeratoconusACTRN12613000143729Royal Victorian Eye and Ear Hospital100
招募中
不适用
Prospective multicenter study corneal endothelial cell loss in cataract surgery with pseudoexfoliation syndromePseudoexfoliation syndromeJPRN-UMIN000040893Kyoto Prefectural University of Medicine120