A PILOT RANDOMIZED CONTROLLED TRIAL TO STUDY THE EFFECT OF ORAL BIOENHANCED CURCUMIN IN DRY EYE DISEASE

Phase 3

• Conditions: Health Condition 1: H04- Disorders of lacrimal system

• Registration Number: CTRI/2022/01/039537
• Lead Sponsor: rp centre of ophthalmic sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 21 February 2022

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

6.

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 <= 32

Tear osmolarity >= 316 mOsm/L, in at least one eye

5) Best corrected visual acuity >= 20/40

6) IOP <= 21 mmHg in both eyes.

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PRIMARY OUTCOME MEASURES <br/ ><br>Tear osmolarity <br/ ><br>Ocular surface disease index <br/ ><br> <br/ ><br>SECONDARY OUTCOMES MEASURES <br/ ><br>Tear film stability <br/ ><br>Ocular redness <br/ ><br>Tear inflammatory cytokines (IL1, IL6, IL8, MMP9, TNFα) <br/ ><br>Timepoint: 0 MONTH <br/ ><br>1 MONTH <br/ ><br>2 MONTH <br/ ><br>3 MONTH

Secondary Outcome Measures

Name	Time	Method
SECONDARY OUTCOMES MEASURES <br/ ><br>Tear film stability <br/ ><br>Ocular redness <br/ ><br>Tear inflammatory cytokines (IL1, IL6, IL8, MMP9, TNFα) <br/ ><br>Timepoint: 0 MONTH <br/ ><br>1 MONTH <br/ ><br>2 MONTH <br/ ><br>3 MONTH