Health Condition 1: H04- Disorders of lacrimal system
Conditions
Interventions
Intervention1: BIOENHANCED CURCUMIN
( CURCUMIN WITH ESSENTIAL OIL OF CURCUMIN): BIOENHANCED CURCUMIN 500mg
ROUTE: ORAL ADMINISTRATION
FREQUENCY: TWICE A DAY
DURATION : 90 DAYS
Control Intervention1: P
Sponsors
rp centre of ophthalmic sciences
Eligibility
Inclusion criteria
Inclusion criteria: 6. Inclusion criteria: 1) >= 18 years of age 2) provision of written informed consent to participate; 3) for females of childbearing potential, a negative pregnancy test result at baseline 4) Mild to Moderate dry eye disease OSDI score of >= 19.5 and Tear osmolarity >= 316 mOsm/L, in at least one eye 5) Best corrected visual acuity >= 20/40 6) IOP
Exclusion criteria
Exclusion criteria: Exclusion criteria : 1) Diabetes mellitus; 2) consumption of curcumin oral supplements in the three months prior to enrolment 3) history of contact lens use 1 month prior 4) history of prior ocular surgery 5) history of over the-counter, herbal, prescription, or nutritional supplement use. 6) presence of any ocular comorbidity i.e., active ocular infection or ocular inflammation, active ocular allergy, a severe blepharitis, which in the judgment of the investigator, may interfere with the interpretation of the study results
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PRIMARY OUTCOME MEASURES Tear osmolarity Ocular surface disease index SECONDARY OUTCOMES MEASURES Tear film stability Ocular redness Tear inflammatory cytokines (IL1, IL6, IL8, MMP9, TNFα) Timepoint: 0 MONTH 1 MONTH 2 MONTH 3 MONTH | — |
Secondary
| Measure | Time frame |
|---|---|
| SECONDARY OUTCOMES MEASURES Tear film stability Ocular redness Tear inflammatory cytokines (IL1, IL6, IL8, MMP9, TNFα) Timepoint: 0 MONTH 1 MONTH 2 MONTH 3 MONTH | — |
Countries
India
Contacts
Public ContactDIKSHIT KAPIL
RP CENTRE OF OPHTHALMIC SCIENCES AIIMS NEW DELJI
Outcome results
None listed