CTRI/2025/02/080686已完成Phase 3 4
A randomized double-blind placebo-controlled clinical study for the comparative evaluation of efficacy and tolerability of XanMax® 2002 in adult subjects with dry eye symptoms
Katra Phytochem (India) Private Limited1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年2月28日最近更新:
试验速览
- 阶段
- Phase 3 4
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Ocular Surface Disease Index (OSDI): Change in OSDI scores from baseline to the end of the study, assessing symptoms of dry eye, visual function, and environmental triggers.
研究概览
简要总结
Building on the robust preclinical and clinical evidence, the current study aims to evaluate the efficacy and tolerability of XanMax® 2002, a novel formulation containing lutein and zeaxanthin, in adult subjects with DED. The present study is designed to confirm the efficacy and safety of lutein and zeaxanthin with the study title—“A randomized double-blind placebo-controlled clinical study for the comparative evaluation of efficacy and tolerability of XanMax® 2002 in adult subjects with dry eye symptoms.”
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Double
入排标准
- 年龄范围
- 40.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or female participants aged 40 to 75 years.
- •Participants who spend at least four hours per day engaged in screen-based activities (e.g., watching television, using a computer, laptop, or other digital devices).
- •Participants reporting symptoms of dry eye, such as irritation, pain, or itching, along with vision-related symptoms such as glare.
- •Participants with a tear break-up time (TBUT) of less than 10 seconds, as measured during screening.
- •Willingness and ability to attend scheduled follow-up visits and comply with the study protocol.
- •Ability to provide written informed consent prior to participation.
排除标准
- •Diagnosis of any significant ophthalmic disease.
- •Presence of ocular conditions, including but not limited to cataracts, corneal diseases, ocular surface disorders, glaucoma, retinal diseases, or severe myopia (mild to moderate myopia is permitted).
- •History of eye surgery or regular use of contact lenses for more than three days per week.
- •Diagnosis of any recent or uncontrolled medical conditions, including but not limited to hypertension, diabetes mellitus, cardiovascular disease, gastrointestinal disorders, gallbladder disease, rheumatoid arthritis, other autoimmune diseases, endocrine disorders, or active malignancy.
- •History or diagnosis of psychiatric or neurological conditions, excluding mild to moderate depression or anxiety.
- •Regular use of medications known to affect ocular health or study outcomes, including but not limited to corticosteroids, hormone replacement therapy, antihistamines, beta-blockers, tricyclic antidepressants, or ocular medications such as eye drops.
- •Recent changes in medication regimen within the past three months or an expectation to change medications during the study period.
- •Current use of vitamins, lutein, zeaxanthin, or other supplements that may interfere with study outcomes.
- •History of illicit drug use within the past 12 months or alcohol consumption exceeding 14 standard drinks per week.
- •Pregnant or breastfeeding women or those planning to conceive within six months of the study start date.
- •History of significant surgery within the past 12 months.
- •Planned major lifestyle changes (e.g., relocation, job changes) during the study period.
- •Use of artificial tears more than seven times per day.
- •Diagnosis of Sjögren’s syndrome or any other systemic condition associated with dry eye disease.
- •Individuals working regular late-night shifts.
- •Any condition that, in the opinion of the Principal Investigator, may interfere with the participant’s ability to comply fully with the study protocol, pose a significant safety risk, or affect the interpretation of study results.
结局指标
主要结局
Ocular Surface Disease Index (OSDI): Change in OSDI scores from baseline to the end of the study, assessing symptoms of dry eye, visual function, and environmental triggers.
时间窗: Screening Day 45 and Day 90
Tear Film Break-Up Time (TBUT): Change in TBUT from baseline to the end of the study, evaluating the stability of the tear film.
时间窗: Screening Day 45 and Day 90
次要结局
- 1. Visual Analog Scale (VAS) for Pain: Change in subjective pain scores on a 0 to 100 mm VAS scale from baseline to study completion.(2. Visual Fatigue Scale (VFS): Change in visual fatigue scores from baseline, measuring eye strain and discomfort during screen use.)
- 5. Fluorescein Staining: Change in ocular surface staining scores (e.g., corneal or conjunctival) using fluorescein dye to assess epithelial damage.(6. Computer Vision Syndrome Questionnaire (CVS Q): Change in CVS Q scores from baseline, evaluating symptoms of digital eye strain)
- Safety – Basic hematology biochemistry parameters and urine analysis
研究者
Dr P Seshu Babu
Government Medical College and Hospital (RIMS)
研究点 (1)
Loading locations...
相似试验
尚未招募
不适用
A Proof of Concept, Randomized, Double Blind, Placebo Controlled Clinical Trial to Assess the Effect of GH-LS-R1 on Respiratory Health.CTRI/2025/07/089984Verisearch Lab16
尚未招募
不适用
A Clinical Study to Assess the Safety and Efficacy of Scalp Cream in patients with DandruffCTRI/2025/07/090946Blossom Microbiotics LLC34
撤回
1 期
Phase I, double-blind, randomized, placebo-controlled study investigating the safety, tolerability and concentrations of the study product KAND145 in healthy volunteersOvarian cancer2023-503909-11-00Kancera AB80
招募中
1 期
Inhaled RB042 in Healthy Adult Volunteers, Healthy Adult Smokers and Patients With Chronic Obstructive Pulmonary DiseaseCOPD (Chronic Obstructive Pulmonary Disease)COPDNCT07285122Atisama Therapeutics105
已完成
不适用
A study to evaluate the effect of TruBlk™ Shilajit Resin on improving sexual health in malesCTRI/2025/07/090919Amaara Ayurveda100