Investigation of the effect of contact lens disinfectants on signs and symptoms of contact lens discomfort in adult daily contact lens wearers
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 17
研究概览
简要总结
Contact lens disinfectants are known to alter the surface properties of contact lenses. However, few studies have investigated the potential effects of contact lens disinfectant-induced changes in contact lens surface properties on the eye and tear film, and none have attempted to correlate these changes with comfort during contact lens wear. Furthermore, the new contact lens disinfectants, which is the first product in the world to contain both polyhexamethylene biguanide hydrochloride and alexidine dihydrochloride, which are disinfectants. This contact lens disinfectant solution has recently been launched in Europe, the United States and other countries. In addition, this new contact lens disinfectant contains a hyaluronic acid derivative, which is expected to adhere to the lens surface and improve the lens's water-wettability over time. However, no studies have yet examined the new contact lens disinfectant and discomfort during lens wear. Therefore, this study will evaluate the effects of contact lens disinfectants on ocular physiology, tear fluid characteristics, and possible symptoms during contact lens wear in soft contact lens wearers with dry eye symptoms, using the new contact lens disinfectant already available in the other countries. The CLDEQ-8 score, used as a measure of discomfort when wearing contact lens (CLD) showed improvement from 17.9±4.2 to 10.2±4.0, and 11of the 17 patients had a decrease in their CLD score to 11 or less, indicating that they would now be classified as asymptomatic contact lens wearers. The function of meibomian gland, the thickness of lipid layer in tear fluid, and the amount of tear fluid in ocular suraface showed no change, while NIBUT on the lens, indicating tear fluid stability on the lens showed improvement from 5.8±1.9 to 10.9±4.7. The combination of Cleadew MPS and Comfilcon A can be expected to improve CLDEQ-8 scores and prolong NIBUT. However, from our results, we can't say more than that the combination of Cleadew MPS and Comfilcon A is useful; if we want to evaluate the performance of Cleadew alone, it is better to change the lens or components of disinfectants and then conduct comparative experiments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Aged 18 years or above
- •Willing to sign informed consent and comply with study schedule
- •Contact lens wearers who have worn lenses for at least 6 months, used contact lenses for 3 weeks before the evaluation visit and used these lenses at least four times a week. Contact lenses should have been worn on daily wear modality, where the lenses are worn for at least 6hours per day and remove the lenses before sleep.
- •Willing to wear their lenses a minimum of 6 hours per day at least 5 days per week for the duration of the study (6 weeks), and to cooperate with the required procedures of diagnostic agent installation, eyelid eversion, and examination.
- •Willing to not use any rewetting eye drops for the duration of the study and to refrain from swimming, showering and/or sleeping while wearing the contact lenses for the duration of the study
- •No noticeable scarring of the ocular surface that should avoid CL wear (no grade 2 or higher staining as a result of a single drop of nonconservative fluorescein solution and examination 1 minute after the drop).
排除标准
- •Any ocular or systemic disease that might influence the tear film or ability to safely wear contact lenses.
- •Any history of previous ocular surgery or trauma, including chalazion exclusion, oculoplastic surgery.
- •Be pregnant, planning to become pregnant during the 6 weeks of the study or be lactating (any participant that does become pregnant during the study should inform the study personnel immediately so that they can be withdrawn from the study since the increased level of hormones can impact ocular comfort during lens wear).
- •Current use of any prescription on non-prescription ocular or systemic medications, including antihistamines.
- •Would be likely to use artificial tear preparations during the period 4 hours before all visits. Use of any ocular ointment during the 3 days before all visits.