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.
Trial Snapshot
- Phase
- Phase 3 4
- Status
- Completed
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Primary Endpoints:
Study Overview
Brief Summary
Lutein Lutein is a type of carotenoid, which are pigments found in plants. It’s known for its strong antioxidant properties and is often referred to as "the eye vitamin" due to its benefits for eye health2. Lutein is concentrated in the retina, particularly in the macula, which is responsible for central vision. It helps filter harmful blue light and protects the eyes from oxidative stress, reducing the risk of age-related macular degeneration (AMD) and cataracts3. Additionally, lutein may support cognitive function and heart health. Meso-zeaxanthin is another carotenoid found in the macula. It’s less common in the diet and is often synthesized in the body from other carotenoids3. Meso-zeaxanthin works alongside lutein and zeaxanthin to form the macular pigment, which protects the eyes from blue light and oxidative damage. It’s believed to improve ocular blood flow and reduce the risk of AMD. Zeaxanthin is similar to lutein and is also found in the macula. It has potent antioxidant properties and helps protect the eyes from harmful light and oxidative stress3. Zeaxanthin is concentrated in the center of the retina, while lutein is found in the peripheral regions. Together, they form the macular pigment, which is crucial for maintaining sharp vision and reducing the risk of eye diseases like AMD and cataracts.
Lutein, meso-zeaxanthin and zeaxanthin are carotenoids that play a significant role in eye health, particularly in managing Keratoconjunctivitis Sicca (KCS). These nutrients are known for their antioxidant and anti-inflammatory properties, which help protect the eyes from oxidative stress and inflammation. Lutein and zeaxanthin are concentrated in the macula, the central part of the retina, where they help filter harmful blue light and neutralize free radicals. This reduces oxidative stress, which can exacerbate dry eye symptoms. These carotenoids have been shown to reduce inflammation in the ocular surface, which is beneficial for managing the symptoms of KCS. Also, it enhances the overall health of the ocular surface, lutein, meso-zeaxanthin, and zeaxanthin can contribute to better tear film stability, reducing tear evaporation and dryness. The Supplementation with these carotenoids has been associated with improved visual performance, including better contrast sensitivity and visual acuity.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Double
Eligibility Criteria
- Ages
- 18.00 Year(s) to 55.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Indian volunteers aged between 18 to 55 years.
- •Confirmed diagnosis of keratoconjunctivitis sicca.
- •Participants must have a Tear Film Breakup Time (TBUT) of less than 10 seconds.
- •Participants must have a Schirmer’s test score of 10 mm or less of wetting after 5 minutes.
- •Participants must have an Ocular Surface Disease
- •Index (OSDI) score of 13 or higher.
- •Normal Lid position and closure.
- •Willing to give written Informed Consent.
Exclusion Criteria
- •Pregnant, Breastfeeding, subjects undergone any surgery and else take taken part in any clinical Trial.
- •Not willing to Sign the ICF or give the consent
- •History of hypersensitivity to lutein or zeaxanthin.
- •Unwilling to avoid wearing contact lenses for the entire duration of the study.
- •Use of systemic or topical corticosteroids within 30 days prior to screening.
- •History of ocular surgery within the past 6 months.
- •Any other condition that, in the opinion of the investigator, would interfere with the study assessments or safety.
- •Participation in another clinical trial during the study period.
Outcomes
Primary Outcomes
Primary Endpoints:
Time Frame: Screening Visit, Day 45 and Day 90.
1.Changes in Tear film break-up (TFBU).
Time Frame: Screening Visit, Day 45 and Day 90.
2.Changes in Schirmer’s test.
Time Frame: Screening Visit, Day 45 and Day 90.
3.Changes in OSDI Questionnaire
Time Frame: Screening Visit, Day 45 and Day 90.
Secondary Outcomes
- Secondary Endpoints:(1.To assess the safety of the product through safety Assessment(Screening Visit and Day 90))
Investigators
Dr Ashok Godavarthi
Radiant Research Services Pvt Ltd