CTRI/2021/01/030493已完成不适用
A prospective, randomized, double-blind, multiple dose, parallel, placebo-controlled, clinical interventional study of a dietary supplement of OmniActive Health Technologies, India, in adult Subjects with Dry Eye Syndrome (DES)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1.Schirmer’s Test
研究概览
简要总结
A prospective, randomized, double-blind, multipledose, parallel, placebo-controlled, clinical interventional study of a dietary supplementof OmniActive Health Technologies, India, in adult Subjects with Dry EyeSyndrome (DES).At Visit 2, eligible subjects shall receive sufficient capsules forrandomized study product (i.e., Test, or Placebo). Subjects shall be instructed to consume one capsule every morning after the breakfast,at the same time every day, for 56 days (8 weeks).
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male and/or female subjects aged between 18 and 65 years (both limits inclusive).
- •2.Clinical diagnosis of symptomatic Dry Eye Syndrome confirmed, at Baseline by presence of irritation, foreign body (sandy) sensation, feeling of dryness, itching, non-specific ocular discomfort and altered/effected QoL at least in any one of the eye.
- •3.Subjects shall be in good health and free from any clinically significant disease, other than Dry Eye Syndrome (DES), that might interfere with the study evaluations.
- •4.Subjects with (at least in any one of the eye) iv.Schirmer’s Test without anaesthesia ≤ 10 mm.
- •v.Ocular Surface Disease Index (OSDI) Test symptoms between 12 and
- •vi.Tear film break up time ≤ 10 seconds 5.Subjects with any of the following (at least in any one of the eye) iii.Tear Osmolarity ≥ 316 milliosmole /L.
- •iv.Subjects with Fluorescein corneal staining ≥ 1 and <
- •6.Subjects must have clinically acceptable results from all the screening laboratory parameters and investigations.
- •7.Female Subjects of child bearing potential practicing an acceptable method of birth control such as Intrauterine Device in place for at least 3 months prior to the start of the study and remaining in place during the study period, contraceptive transdermal, injection or implants, non-hormonal or hormonal, abstinence; Subjects who shall be practicing abstinence shall agree to have a documented second acceptable method of birth control should the subject become sexually active during the course of her study participation for the duration of the study as judged by the Investigator(s)/study physician and agree to follow the same should be used during treatment.
- •OR Postmenopausal for at least 1 year.
- •OR Surgically sterile (bilateral tubal ligation/bilateral oophorectomy/ hysterectomy has been performed on the Subject).
- •8.Subject willing to provide written consent.
- •9.Subjects shall be willing and able to understand and comply with the requirements of the study, apply the medication as instructed, return for the required treatment period visits, comply with therapy prohibitions, and be able to complete the study.
排除标准
- •1.Subjects who are pregnant, nursing, or planning a pregnancy within the study participation period.
- •2.Subject with positive Urine Pregnancy Test at screening/randomization.
- •3.History of allergy or sensitivity to Lutein, Zeaxanthin, Curcumin or Vitamin D3, related compounds or any component of the formulation.
- •4.Presence of severe dry eye syndrome with complications such as perforated Corneal Ulcer, Uveitis and Glaucoma, in the Investigator’s opinion that may interfere with the evaluation of the Subject’s Dry Eye Syndrome (DES).
- •5.Current evidence of ocular infections or inflammatory conditions like acute conjunctivitis or other medical condition that, in the Investigator’s opinion, would place the Subject at undue risk by participating or compromise the integrity of the study data.
- •6.Subject with poorly controlled diabetes mellitus, rheumatoid arthritis and Systemic Lupus Erythematosus (SLE) which causes Dry Eye Syndrome.
- •7.Subjects with herpetic eye disease.
- •8.Subjects with chronic infection of the lacrimal gland.
- •9.Subjects with Laser In Situ Keratomileusis (LASIK).
- •10.Subjects with poorly controlled hypertension (>140/96 mm of Hg).
- •11.Subjects with evidence of malignancy.
- •12.Subjects suffering from major systemic illness necessitating long term drug treatment (Psycho-Neuro- Endocrinal disorders, etc.).
- •13.Subjects with concurrent serious Hepatic Dysfunction or Renal Dysfunction, uncontrolled Pulmonary Dysfunction (asthmatic and Chronic Obstructive Pulmonary Disease (COPD) Subjects) or other concurrent severe disease.
- •14.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.
- •15.Subjects willing to stop use of ocular topical medications and contact lens during intervention.
- •17.Use of lutein, zeaxanthin, curcumin or vitamin D3 on prescription for other medical indications or for health-conscious reasons.
- •18.Use of steroids, oral contraceptive pills, estrogen replacement therapy or any other medication that may adversely affect the outcome of the study.
- •19.Subjects on aspirin or anti-coagulant therapy.
- •20.Subjects with any other medical condition that might adversely impact the safety of the study participants or confound the study results.
- •21.Subjects who have been treated with an investigational drug or investigational device within a period of 3 months prior to study entry.
结局指标
主要结局
1.Schirmer’s Test
时间窗: Visit 5
2.Ocular Surface Disease Index
时间窗: Visit 5
次要结局
- 1.Tear Film Break-Up Time (TBUT)(2.Standard Patient Evaluation of Eye Dryness (SPEED))
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
To assess the efficacy and safety of an Immunostimulant supplement on the immunity of healthy human subjectsCTRI/2021/07/035206OmniActive Health Technologies30
已完成
3 期
A Clinical Trial to study effect of heparin sodium topical solution inprevention of infusion associated phlebitis.CTRI/2017/03/008263Troikaa Pharmaceuticals Limited374
已完成
3 期
A clinical study to assess the efficacy and safety of Naftifine cream in patients with superficial fungal infection of skinCTRI/2022/03/041466Zydus Healthcare Limited268
已完成
2 期
A Phase 2 Dose-finding Study of Atacicept in Subjects With Rheumatoid Arthritis (AUGUST I)Rheumatoid ArthritisNCT00430495EMD Serono256
已完成
3 期
Clinical trial to evaluate the Efficacy and safety of NIMODIN IV infusion 50 ml with Nimotop IV infusion 50 ml for the treatment of intra-cerebral hemorrhageCTRI/2020/06/025822Swiss Parenterals Ltd80