CTRI/2025/08/092829招募中不适用
A randomized, double-blind, placebo-controlled study to assess the efficacy of LN24214 in relieving dry eye symptoms
Laila Nutra private limited2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2025年8月19日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Main effects for treatment over the study period
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of LN24214 in relieving the dry eye symptoms. A total of 150 male and female subjects aged between 30 and 60 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 – 100 mg or LN24214 – 200 mg or placebo arms at 1:1:1 ratio. The subjects will be instructed to take One capsule daily in the morning after breakfast for 28 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
- 30.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male and female subjects aged between 30 and 60 years experiencing visual fatigue or eye strain or presenting with symptoms suggestive of dry eye like irritation, foreign body (sandy) sensation, feeling of dryness, itching, non-specific ocular discomfort etc.
- •2.Subjects who daily use video game consoles or a PC, or operate VDT for at least 4 hours per day.
- •3.Subjects who have total corrected visual acuity of at least 1.0 for both eyes, if a refractive error exists, it should be properly corrected.
- •4.Subjects who meet all the following dry eye criteria in either of the eye a)Schirmer’s test score without anesthesia between greater than or equal to 5 and less than or equal to 10 mm.
- •b)Ocular surface disease index (OSDI) scores for inclusion greater than or equal to 13 and less than or equal to
- •c)Tear film break up time between greater than or equal to 5 sec and less than or equal to 10 sec.
- •d)Tear osmolarity range between greater than or equal to 316 milliosmole/L and less than or equal to 360 milliosmole/L.
- •e)Fluorescein corneal staining greater than or equal to 1 and less than or equal to 3 or More than 5 spots of corneal staining or greater than 9 conjunctiva spots or lid margin staining (greater than or equal to 2mm length & greater than or equal to 25 percent width) in at least one eye.
- •f)Subjects with positive result for MMP 9 as assessed by Quidels test.
- •7.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.
- •8.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).
- •9.Has not taken carotenoid supplements (lutein, zeaxanthin, B-carotene, astaxanthin) for 3 months.
- •10.Has not taken fish oils/Omega oils for 2 weeks prior to study.
- •11.Free from any clinically significant disease that might interfere with the study evaluations.
- •12.Has not taken any type of medicine/pharmaceutical supplements/ herbal supplements for the past 3 months related to improve eye health.
- •13.ECG without clinically significant abnormalities.
- •14.Results of screening are within normal range or considered not clinically significant by the Principal Investigator.
- •15.Subjects willing to refrain from using eye drops during the study period.
排除标准
- •1.Diagnosis of dry eye disease 2.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 subject’s dry eye syndrome in the investigator’s opinion.
- •3.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.
- •4.Subjects with Sjogren syndrome.
- •5.Contraindication of pupil dilatation in the study eye.
- •6.Early or Mature cataract or media opacification in either eye which limits an adequate view of fundus.
- •7.Not willing to stop the use of ocular topical medications, steroids, oral contraceptive pills, estrogens replacement therapy, any other medication and contact lenses during the intervention that may adversely affect the outcome of the study.
- •8.With diagnosed diabetes mellitus, rheumatoid arthritis, systemic lupus erythematous, which cause dry eye syndrome.
- •10.Subject participating in another clinical trial or has received an investigational product or dietary supplement within thirty days prior to enrolment.
- •11.High alcohol intake (greater than 2 standard drinks per day), smokers (greater than 5 cigarettes per day) or use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc.).
- •12.Who are pregnant, lactating, planning a pregnancy during the study.
- •13.Subjects with congenital malformations.
- •14.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.
- •15.Subjects have known obstructive pulmonary disease or asthma or allergy to excipients of IP.
- •16.Subjects having post COVID symptoms or underwent treatment for COVID-19 within last 6 months or tested positive during the study will be excluded.
- •17.Subjects having known history of any Sexually transmitted diseases (STD).
- •18.Subject have a recent (less than or equal to 6 months) major surgery or surgery scheduled in the next 4 to 5 weeks.
- •19.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).
结局指标
主要结局
Main effects for treatment over the study period
时间窗: Screening & Randomization (V1)-Day 1, Follow up Visit (V2)-Day 7, Follow up Visit-(V3) Day 14 & Final Visit (V4)-Day 28
The Ocular Surface Disease Index (OSDI)
时间窗: Screening & Randomization (V1)-Day 1, Follow up Visit (V2)-Day 7, Follow up Visit-(V3) Day 14 & Final Visit (V4)-Day 28
次要结局
- Change in the scores before & after supplementation: Schirmer’s test
- Change in the scores before & after supplementation: Tear film break-up time (TBUT) using Fluoro Touch Fluorescein Sodium Ophthalmic Strips & ophthalmoscope(Screening & Randomization (V1)-Day 1, Follow up Visit (V2)-Day 7, Follow up Visit-(V3) Day 14 & Final Visit (V4)-Day 28)
- Change in the scores before & after supplementation: Tear osmolarity(Screening & Randomization (V1)-Day 1,Follow up Visit-(V3) Day 14 & Final Visit (V4)-Day 28)
- Change in the scores before & after supplementation: Tear meniscus height(Screening & Randomization (V1)-Day 1, Follow up Visit (V2)-Day 7, Follow up Visit-(V3) Day 14 & Final Visit (V4)-Day 28)
- Change in the scores before & after supplementation: MMP-9 in Quidel test(Screening & Randomization (V1)-Day 1 & Final Visit (V4)-Day 28)
- Change in the scores before & after supplementation: The national eye institute (NEI) visual function questionnaire (VFQ-25)(Screening & Randomization (V1)-Day 1, Follow up Visit (V2)-Day 7, Follow up Visit-(V3) Day 14 & Final Visit (V4)-Day 28)
研究者
Mr Prason Kumar J
Laila Nutra Private Limited
研究点 (2)
Loading locations...
相似试验
招募中
2 期
A Chronic Pain Master Protocol (CPMP): A Study of LY4065967 in Participants With Diabetic Peripheral Neuropathic PainNCT07285018Eli Lilly and Company150
招募中
2 期
LY4268989 in Adults With Moderately to Severely Active Ulcerative ColitisNCT07415044Eli Lilly and Company1,431
招募中
1 期
A Study of LY4213663 in Healthy Participants and Participants With Rheumatoid ArthritisNCT07258849Eli Lilly and Company141
招募中
1 期
A Study of LY4298445 in Healthy Participants and Participants With Systemic Lupus Erythematosus (SLE) or Rheumatoid Arthritis (RA)Rheumatoid ArthritisSystemic Lupus ErythematosusNCT07276958Eli Lilly and Company68
已完成
2 期
A study to test whether BI 706321 combined with ustekinumab helps people with Crohn's Disease2024-512756-38-00Boehringer Ingelheim International GmbH27