Clinical trail on Eye health with Keratoconjunctivitis Sicca

A Randomized, Double-Blind, two-arm, placebo-Controlled Study to Evaluate the Efficacy and Safety of Lutein 10mg, Meso zeaxanthin 10mg with Zeaxanthin 2mg in Subjects with Keratoconjunctivitis Sicca. - NIL

Status

Recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/03/083269

Enrollment

Registered

2025-03-24

Start date

Unknown

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

Health Condition 1: H04- Disorders of lacrimal system

Interventions

Intervention1: Lutein Meso Zeaxanthin Zeaxanthin: Dose:22 mg Dosing Frequency: capsules, Duration: 90 days One capsule orally in the morning after Break fast Control Intervention1: Starch: Do

Eligibility

Inclusion criteria

Inclusion criteria: 1. Indian volunteers aged between 18 to 55 years. 2. Confirmed diagnosis of keratoconjunctivitis sicca. 3. Participants must have a Tear Film Breakup Time (TBUT) of less than 10 seconds. 4. Participants must have a Schirmer s test score of 10 mm or less of wetting after 5 minutes. 5. Participants must have an Ocular Surface Disease 6. Index (OSDI) score of 13 or higher. 7. Normal Lid position and closure. 8. Willing to give written Informed Consent.

Exclusion criteria

Exclusion criteria: 1. Pregnant, Breastfeeding, subjects undergone any surgery and else take taken part in any clinical Trial. 2. Not willing to Sign the ICF or give the consent 3. History of hypersensitivity to lutein or zeaxanthin. 4. Unwilling to avoid wearing contact lenses for the entire duration of the study. 5. Use of systemic or topical corticosteroids within 30 days prior to screening. 6. History of ocular surgery within the past 6 months. 7. Any other condition that, in the opinion of the investigator, would interfere with the study assessments or safety. 8. Participation in another clinical trial during the study period.

Design outcomes

Primary

Measure	Time frame
Primary Endpoints: 1.Changes in Tear film break-up (TFBU). 2.Changes in Schirmer s test. 3.Changes in OSDI QuestionnaireTimepoint: Screening Visit, Day 45 and Day 90.	—

Secondary

Measure	Time frame
Secondary Endpoints: 1.To assess the safety of the product through safety Assessment(Screening Visit and Day 90) 2.Serum MMP-9 levels(Day 0,Day 45 and Day 90) 3.QOL questionnaire. 4.Ocular discomfort score.Timepoint: Screening Visit, Day 0, Day 45 and Day 90	—

Countries

India

Contacts

Public ContactDr Ashok Godavarthi

Radiant Research Services Pvt Ltd

surya.ashok@gmail.com09880999297

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026