Clinical trial on eye health in healthy elderly volunteers.

A randomized, double blind, placebo-controlled, parallel, three-arm study to evaluate the comparative safety and comparative efficacy of Lutein and Zeaxanthin with or without natural mixed carotenoids to assess positive correlation in MPOD and central foveal thickness levels, in healthy adult subjects

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/06/025599

Enrollment

Registered

2020-06-04

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Active arm 1 Lutein 20 percent Free Zeaxanthin 4 percent Oil Dosage 10 mg of Lutein plus 2 mg of Zeaxanthin: Route : Orally 180 days administered twice daily after meal Dosage form

Eligibility

Inclusion criteria

Inclusion criteria: 1.Men and women aged over 18 to 65 years, both inclusive. 2.Able and willing to follow all study related instructions 3.Subject who are naÃ¯ve to previous lutein or zeaxanthin formulations administration and to any previous intravitreal injections. 4.Females of child-bearing age should be willing to use standard methods of contraception 5.Must be willing to give written informed consent and comply with the study procedures. 6.Subjectâ??s complete blood count parameters to be within clinically acceptable range by Investigator 7.Subjects with MPOD level between 0.2 â?? 0.6 8.Subjects with average thickness of neuroepithelium at fovea centralis of 250ï?m.

Exclusion criteria

Exclusion criteria: 1.Pregnant /lactating women and women who are planning to get pregnant, or less than six months post-partum. 2.History of any uncontrolled and or unstable medical illness. 3.Clinical history of allergy/ hypersensitivity to the study products. 4.Recent (within last 3 months) participation in a clinical trial 5.Subjects having other ocular pathologies eg. glaucoma or age related macular degeneration as assessed by Investigator. 6.Subjects having systemic diseases like renal disorder, hepatic disorder, diabetes mellitus, hypercholesterolemia. 7.Subjects with unstable medical conditions 8.Not willing to follow study restrictions 9.Subjects otherwise judged by the investigator or sub -investigator to be inappropriate for inclusion in the study. 10.No previous Lutein and other antioxidants replacement therapy. 11.Subjects with history of difficulty of swallowing capsules

Design outcomes

Primary

Measure	Time frame
To assess positive correleation between central foveal thickness and MPOD levels in healthy adult subjects on active treatments versus placeboTimepoint: Day 0 and Day 180	—

Secondary

Measure	Time frame
Comparative Safety and tolerability of three study productsTimepoint: Day 0 and Day 180	—

Countries

India

Contacts

Public ContactMr Salman Mehkri

Tejhana Consulting LLP

2019newprojects@gmail.com

Outcome results