Quantification of the Visual Benefits of Soft Toric Contact Lenses Compared to Soft Spherical Contact Lenses Over a Range of Refractive Astigmatism

Coopervision, Inc.1 个研究点分布在 1 个国家目标入组 59 人2021年9月28日

适应症Astigmatism

概览

阶段: 不适用
干预措施: 未指定
疾病 / 适应症: Astigmatism
发起方: Coopervision, Inc.
入组人数: 59
试验地点: 1
主要终点: Visual Acuity
状态: 已完成
最后更新: 2年前

概览研究者入排标准结局指标研究点相似试验

概览

简要总结

The aim of this work is to undertake a range of vision-related measures with soft toric contact lenses soft spherical contact lenses and spectacle lens correction across a range of levels of astigmatism.

详细描述

This will be a randomised, crossover, partially subject-masked (for contact lenses only), non-dispensing study, controlled by cross-comparison.

注册库

clinicaltrials.gov

开始日期

2021年9月28日

结束日期

2022年6月21日

最后更新

2年前

研究类型

Interventional

研究设计

Crossover

性别

All

研究者

发起方

Coopervision, Inc.

责任方

Sponsor

入排标准

入选标准

•Subjects will only be eligible for the study if:
•They are of legal age between 18 and 40 years.
•They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.
•They are willing and able to follow the protocol.
•They are current wearers of any soft contact lens (i.e. have worn lenses in the last six months).
•They have refractive ocular astigmatism between 0.00DC and -1.50DC in one or both eyes.
•They have a spherical component to their ocular refractive error between 0.00 and - 6.00 DS.
•They could attain at least 0.10 logMAR distance high contrast visual acuity in one eye with the study lenses within the available power range.
•They can be fitted satisfactorily with both lens types.
•They own an acceptable pair of spectacles.

排除标准

•Subjects will not be eligible to take part in the study if:
•They have an ocular disorder which would normally contra-indicate contact lens wear.
•They have a systemic disorder which would normally contra-indicate contact lens wear.
•They are using any topical medication such as eye drops or ointment.
•They have had corneal refractive surgery.
•They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
•They are pregnant or breastfeeding.
•They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear.
•They have an amblyopic eye, in which case only dominant eye will be assessed for that subject.
•They have an infectious disease (e.g. hepatitis), any immunosuppressive disease (e.g. HIV) or diabetes.

结局指标

主要结局

Visual Acuity

时间窗: After 30 minutes of dispense (High Contrast VA)

Visual acuity was assessed using logMAR for each intervention.

次要结局

Slit Lamp Biomicroscopy Findings - Corneal Staining(At Exit (After 30 minutes in each of three interventions))
Slit Lamp Biomicroscopy Findings - Corneal Oedema(At Exit (After 30 minutes in each of three interventions))
Slit Lamp Biomicroscopy Findings - Conjunctival Staining(At Exit (After 30 minutes in each of three interventions))
Slit Lamp Biomicroscopy Findings - Conjunctival Redness(At Exit (After 30 minutes in each of three interventions))
Slit Lamp Biomicroscopy Findings - Limbal Redness(At Exit (After 30 minutes in each of three interventions))
Slit Lamp Biomicroscopy Findings - Papillary Conjunctivitis(At Exit (After 30 minutes in each of three interventions))