A study to compare the effectiveness, benefits and risks of four eye drops prednisolone acetate 1%, dexamethasone 0.1%, loteprednol etabonate 0.5% and difluprednate 0.05% in patients with red, swollen, painful eyes after cataract surgery.

A comparative, randomized, open label clinical study to assess the efficacy and safety of topical prednisolone acetate 1%, dexamethasone 0.1%, loteprednol etabonate 0.5% and difluprednate 0.05% eye drops in postoperative ocular inflammation following cataract surgery.

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/01/022874

Enrollment

140

Registered

2020-01-20

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: H259- Unspecified age-related cataract

Interventions

Intervention1: Difluprednate 0.05%: Eye drop four times a day in first week, four times a day in second week, three times a day in third week, three times a day in fourth week, two times a day in fift

Eligibility

Inclusion criteria

Inclusion criteria: 1.Subjects with senile cataract with an indication for cataract extraction. 2.Subjects willing to give informed consent and be available for regular follow up.

Exclusion criteria

Exclusion criteria: 1.Subjects with congenital and traumatic cataract. 2.Subjects with recurrent infectious and/or inflammatory eye diseases. 3.Subjects with uncontrolled diabetes or associated with complications. 4.Subjects with history of auto-immune diseases. 5.Subjects who are immunocompromised or having tuberculosis, human immunodeficiency virus (HIV) infection. 6.Subjects who develop intra-operative complications during surgery. 7.Subjects with history of hypersensitivity to study drugs. 8.Subjects with history of steroid use 14 days prior to surgery. 9.Subjects with active ocular and/or ENT infections. 10.Subjects with uncontrolled glaucoma.

Design outcomes

Primary

Measure	Time frame
Efficacy parameters: 1.Anterior chamber cell and flare grading as per standardization of uveitis nomenclature (SUN). 2.Ocular pain assessed by Visual Analogue Scale (VAS). Timepoint: 6 weeks.	—

Secondary

Measure	Time frame
Safety and tolerability parameters: 1.Intraocular Pressure measured with tonometry. 2.Adverse drug event monitoring. Timepoint: 6 weeks	—

Countries

India

Contacts

Public ContactDr DINKAR BERI

KEMPEGOWDA INSTITUTE OF MEDICAL SCIENCES

vijendra_ramaiah@yahoo.co.in9980033334

Outcome results

None listed

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