Chloroquine phosphate 0.03% eye drops vs cyclosporine A 0.05% eye drops in dry eye disease

Efficiency of chloroquine phosphate 0.03% eye drops in comparison with cyclosporine A 0.05% eye drops in dry eye disease - a Cross over trail

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/12/029484

Enrollment

Registered

2020-12-01

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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: application of chloroquine phosphate 0.03% eye drops: chloroquine phosphate 0.03% eye drops applied twice a day for a period of two months. Control Intervention1: cyclosporine 0.05% ey

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients with diagnosis of dry eye (ocular surface disease index [OSDI] score greater than 12), presence of any one or more following signs (fluorescein- Tear break-up time less than 10 seconds, Schirmer test 1 less than 10 mm in 5 minutes or presence of ocular surface staining) will be eligible for inclusion. 2.Patients Willing to give informed consent and to comply with the study protocol

Exclusion criteria

Exclusion criteria: 1.Patients with any ocular disorder including ocular injury, infection, non-dry eye ocular inflammation, trauma, or surgery within the prior 6 months 2.Patients receiving concurrent treatment that could interfere with interpretation of the study results 3.Patients having any uncontrolled systemic disease or significant illness 4.Patients who require surgical correction of dry eyes, Contact lens wearers. 5.Patients with any known contraindications or hypersensitivity to drugs 6.Patients who are chronic alcoholics, pregnant or nursing women or patient with Sjogren syndrome will be excluded

Design outcomes

Primary

Measure	Time frame
To compare the effect of chloroquine phosphate 0.03% eye drops and cyclosporine A 0.05% eyedrops on (a) ocular surface disease index(OSDI) (b) fluorescein tear break up time(FTBUT) (c) ocular surface staining score (d) schirmers 1 test Timepoint: Visit 1- on the day of presentation Visit 2- two months from day of visit 1 visit 3- one month from the day of visit 2 visit 4- two months from the day of visit 3	—

Measure

Time frame

To compare the effect of chloroquine phosphate 0.03% eye drops and cyclosporine A 0.05% eyedrops on (a) ocular surface disease index(OSDI) (b) fluorescein tear break up time(FTBUT) (c) ocular surface staining score (d) schirmers 1 test Timepoint: Visit 1- on the day of presentation Visit 2- two months from day of visit 1 visit 3- one month from the day of visit 2 visit 4- two months from the day of visit 3

—

Secondary

Measure	Time frame
Tear meniscus height,visual acuityTimepoint: Total visits-4 Visit 1- on the day of presentation Visit 2- two months from day of visit 1 visit 3- one month from the day of visit 2 visit 4- two months from the day of visit 3	—

Countries

India

Contacts

Public ContactDr Eswar Rao Sakare

Sankara Eye Hospital Guntur

sudhakar.cmo@sankaraeye.com9705190929

Outcome results

None listed

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