CTRI/2026/01/102401尚未招募不适用
A randomized, double-blind, placebo-controlled study to assess the efficacy of LN24214 in adolescents with digital eye strain
Laila Nutra private limited2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2026年2月10日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 2
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of LN24214 in reducing digital eye strain. A total of 100 male and female subjects aged between 13 to 19 years will be included in the study. Assessment of inclusion and exclusion criteria will be done based on clinical and laboratory investigations. The eligible subjects will be randomized as per the computer generated randomization list. The subjects will be assigned to either LN24214 - 200 mg or placebo arms at 1:1 ratio. The subjects will be instructed to take One capsule daily in the morning after breakfast for 42 days. Apart from primary and secondary outcomes, the study will also record the vital signs and adverse events to evaluate the herbal compositions safety and tolerability. The safety assessment of the LN24214 will also include routine laboratory investigations on blood, urine and clinical chemistry at screening and the final visit of the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 13.00 Year(s) 至 19.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male and female adolescents age between 13 to 19 years with BMI of 18.5 to 26 kg per meter square.
- •2.Self-reported or parent-reported average daily digital screen time of greater than or equal to 4 hours per day for the last greater than or equal to 3 months.
- •3.Participants who have complained of eye strain on use of digital device.
- •4.Participant with CVS-Q score between 8 and
- •5.Best Corrected Visual Acuity (BCVA) of 20/
- •6.Participants with less than or equal to 12.5 cm and greater than or equal to 6 cm on Near Point Accommodation (NPA) test.
- •7.Willing to participate in the study and was able to read and write.
- •8.Parent or Guardian-reported general good health.
- •9.Sign informed consent and complete all tests and procedures as listed in the protocol.
- •10.Females of childbearing potential who are sexually active must agree to use adequate non-hormonal contraception during the study.
- •11.Subject willing to maintain diet tracker and agrees to maintain current dietary habits through end of study period.
- •12.Subject agrees not to consume any supplements including beverages, herbal, vitamins (Such as Folate, B12, and B6 containing multivitamins), drugs including OTC medications (pain relievers, antihistamines, other allergy medications, cold/ flu remedies), prescriptions, recreational drugs and nutritional products during the study period.
- •13.Subject agrees to limit their intake of coffee (less than or equal to 4 cups a day), tea (less than or equal to 3 cups a day), cola (less than or equal to 3 cups a day), energy drinks (less than or equal to 350 ml or 1.4 cans), chocolate (less than 10 gms of dark chocolate).
- •14.Has not taken carotenoid supplements (lutein, zeaxanthin, B-carotene, astaxanthin) for 3 months.
- •15.Has not taken fish oils or Omega oils for 2 weeks prior to study.
- •16.Free from any clinically significant disease that might interfere with the study evaluations.
- •17.Has not taken any type of medicine or pharmaceutical supplements or herbal supplements for the past 3 months related to improve eye health.
- •18.ECG without clinically significant abnormalities.
- •19.Results of screening are within normal range or considered not clinically significant by the Principal Investigator.
- •20.Subjects willing to refrain from using eye drops during the study period.
排除标准
- •1.Participants who wear contact lenses.
- •2.Participants with any diagnosed ocular motility disorder or accommodative or binocular vision issues.
- •3.Participants who are colour-blind.
- •4.Participant on any retinols and carotenoid supplements.
- •5.Participants who have immunosuppressive disorders or are taking immunosuppressive medication.
- •7.Participants who underwent Ophthalmic laser treatment (less than 3 months).
- •8.Systemic disease associated with dry eye or diagnosed with dry eye disease or Blepharitis 9.Having liver (chronic liver failure, cirrhosis, all types of hepatitis), kidney (chronic kidney disease, haemodialysis) or haematological (anaemia, thalassemia, haemophilia) disorders.
- •10.Psychiatric disease or mental retardation (bipolar disorder, depression, schizophrenia).
- •11.Cancer (all types), and endocrine disorders (Cushings disease, gigantism and hyperthyroidism).
- •12.Subjects with the presence of severe dry eye syndrome with complications such as perforated corneal ulcer, uveitis, glaucoma, that may interfere with the evaluation of the subjects dry eye syndrome in the investigators opinion.
- •13.Subjects with herpetic eye disease, history of lacrimal gland infections, laser in situ keratomileusis and with any ocular trauma or surgery that may affect corneal sensitivity and/or normal tear distribution (e.g., cataract surgery, refractive surgery) within the 6 previous months to study inclusion.
- •14.Subjects with Sjogren syndrome.
- •15.Subjects with contraindication of pupil dilatation in the study eye.
- •16.Early or Mature cataract or media opacification in either eye which limits an adequate view of fundus.
- •17.Not willing to stop the use of ocular topical medications, steroids, any other medication and contact lenses during the intervention that may adversely affect the outcome of the study.
- •18.Subjects with diagnosed diabetes mellitus, rheumatoid arthritis, systemic lupus erythematous, which cause dry eye syndrome.
- •20.Subject participating in another clinical trial or has received an investigational product or dietary supplement within thirty days prior to enrolment.
- •21.Consumption of alcohol, smoking cigarettes or use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc.).
- •22.Subjects with congenital malformations.
- •23.Subject has any medical condition or uses any medication, nutritional product, protein powder, dietary supplement or program, which in the opinion of the investigator, might interfere with the conduct of the study or place the subject at risk.
- •24.Subjects have known obstructive pulmonary disease or asthma or allergy to excipients of IP.
- •25.Subjects having post COVID symptoms or underwent treatment for COVID-19 within last 6 months or tested positive during the study will be excluded.
- •26.Subjects having known history of any Sexually transmitted diseases (STD).
- •27.Subjects have a recent (less than or equal to 6 months) major surgery or surgery scheduled in the next 4 to 5 weeks.
- •28.Subject has any findings on physical examination or results of laboratory analyses, which in the opinion of the investigator, are clinically significant deviations from the normal laboratory ranges (i.e., laboratory values greater than 2x the upper limit of normal values).
研究者
Mr Prason Kumar J
Laila Nutra Private Limited
研究点 (2)
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