A Clinical Study to evaluate the efficacy, safety and tolerability of Lifitegrast 5% eye drops in patients with dry eye disease

A randomized, double blind, parallel group, active controlled, multicentric, phase III study comparing the efficacy, safety and tolerability of Lifitegrast 5% eye drops in patients with dry eye disease

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/10/037204

Enrollment

370

Registered

2021-10-08

Start date

Unknown

Completion date

Unknown

Last updated

2023-04-03

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

Conditions

Health Condition 1: H041- Other disorders of lacrimal gland

Interventions

Intervention1: Lifitegrast 5% eye drops: BID for 12 weeks Control Intervention1: Carboxymethylcellulose 0.5% eye drops: BID for 12 weeks

Eligibility

Inclusion criteria

Inclusion criteria: • Subjects >=18 years to 65 years of age both gender • Subjects with known case of dry eye disease • Subject on artificial tears for the past 30 days for DED • Best Corrected Visual Acuity (BCVA) of 6/24 [Log MAR equivalent (0.6)] or better • Normal lid position and closure. • In case of women, postmenopausal ( >12 months without menstrual bleeding), • Surgically sterilized, or on use of effective birth control measures • Willingness to sign written informed consent document

Exclusion criteria

Exclusion criteria: • Women of childbearing potential if pregnant (test positive for pregnancy) at screening visit, breastfeeding, or not in agreement to use adequate birth control methods to prevent pregnancy throughout the study. • Any ocular condition that, in the opinion of the Investigator, could affect study parameters. This include, active ocular infection, ocular inflammation, glaucoma, and/or diabetic retinopathy or, any other condition as deemed by the Investigator. • Any significant illness that could interfere with study parameters • History of any other ocular surgical procedure within 12 months • Subject with known allergy or hypersensitivity to the components of the formulation • Participation in another clinical trial within past 30 days

Design outcomes

Primary

Measure	Time frame
The mean change in Eye dryness scoreTimepoint: baseline, Week-2, Week-6 and Week-12	—

Secondary

Measure	Time frame
The mean change in the Schirmer Tear Test (without anesthesia) The mean change in Subject rated global improvement scaleTimepoint: from baseline to Week-2, Week-6 and Week-12	—

Countries

India

Contacts

Public ContactDr Krishna Kumar M

Micro Labs Limited

drmanjula@microlabs.in08022370451

Outcome results

None listed

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