None listed
Conditions
Interventions
Intervention1: XanthogreenTM: Dose: 40 mg lutein ester
Dosage form: Capsule
Frequency: Once daily for 90 days
Route of administration: Oral
Intervention2: XanthogreenTM Ultra: Dose: 20 mg lutein es
Sponsors
India Glycols Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Volunteers of either sex, between 18 to 50 (both inclusive) years of age. 2.Macular Pigment Optical Density (MPOD) 0.20-0.35 by flicker photometry both inclusive. 3.Volunteers with no clinically significant ocular pathological condition but having problems with accommodation can be included. 4.20/20 or corrected vision. 5.Able to give informed consent. 6.Willing to come for regular follow –up visits
Exclusion criteria
Exclusion criteria: 1.Macular Pigment Optical Density (MPOD) 0.35. 2.History of age-related macular degeneration. 3.The presence of color blindness. 4.Volunteers having other ocular pathologies like glaucoma, mature cataract, pan retinal degenerations, AMD etc... 5.Individuals with only one functional eye. 6.Volunteers having systemic diseases like hyper-cholesterolemia, renal disorder, liver disorder, diabetes mellitus and other debilitating diseases. 7.History of epileptic seizures. 8.Smokers 9.Individuals with a history of alcohol consumption in past 30 days and those unwilling and unable to commit to abstain from alcohol consumption during the study period. 10.Pregnant women & women who are planning for pregnancy during the study. 11.Individual who diagnosed with low macular pigment density within last three months and/or received any treatment for low macular pigment density. 12.Illiterate individuals. 13.Known history of hypersensitivity to herbal extracts or dietary supplements. 14.On-going treatment with herbals or allopathic ocular drugs. 15.History of having received any investigational drug or participated in any other clinical trial which ended in the preceding six months or is currently ongoing. 16.Individual with any carotenoid trial participation history within the last one year. 17.Any condition that is in the opinion of the investigator does not justify the patient’s inclusion for the study. 18.Only the subjects whose screening data are within the inclusion and exclusion criteria defined, will be enrolled into the study. Those subjects who have screening values outside the normal limits may be enrolled only if the study doctor confirms in writing that these values are of no clinical significance and will have no impact on the outcome of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Macular Pigment Optical DensityTimepoint: Day 0 Screening and or Baseline Day 15 Day 30 Day 60 and Day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 Change in visual processing speed 2 Change in contrast sensitivity 3 Change in Intraocular Pressure 4 Dry eye 5 Treatment acceptability Subject and Physician Global Assessment based by Lickert Scale 6 Safety a Occurrence of adverse events and SAE b Change in Hematological Blood Biochemistry and urine analysis pre and post treatment Timepoint: 1 Day 0 screening and or baseline Day 15 Day 30 Day 60 and Day 90 2 Day 0 screening and or baseline Day 15 Day 30 Day 60 and Day 90 3 Day 0 screening and or baseline Day 15 Day 30 Day 60 and Day 90 4 Day 0 screening and or baseline Day 15 Day 30 Day 60 and Day 90 5 Day 90 6 a Throughout the study period b Day 0 screening and or baseline and Day 90 | — |
Countries
India
Contacts
Public ContactDr Sujay Gowda
India Glycols Ltd
Outcome results
None listed