Bioequivalence study of SPILs Loteprednol with reference Lotemax

Aqueous Humor Bioequivalence Study of Loteprednol 0.5 %, Sun Pharmaceutical Industries Ltd (SPIL) and Lotemax in Patients Undergoing Cataract Surgery: A Randomized, Open Label, Two Treatment, Two Period, Two Sequence, Single Dose, Cross over, Active Controlled Study

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2013/10/004114

Enrollment

Registered

2013-10-30

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: null- cataract extraction Health Condition 2: H268- Other specified cataract

Interventions

Intervention1: SPILs Loteprednol: Topical ocular single dose administration Control Intervention1: Comparator reference drug: Topical ocular single dose administration

Eligibility

Inclusion criteria

Inclusion criteria: -Men or women >=18 years of age (no upper age limit mentioned in the protocol) -Willing to give informed consent -elected for cataract extraction

Exclusion criteria

Exclusion criteria: -history of hypersensitivity to any of the components used in the preparation of the study drug -History of chronic or recurrent severe inflammatory eye disease

Design outcomes

Primary

Measure	Time frame
Pharmacokinetic assessmentTimepoint: Pre-dose, 30 min, 60 min, 90 min, 120 min, 240 min and 360 minutes	—

Secondary

Measure	Time frame
SafetyTimepoint: Visit 2 to Visit 6	—

Countries

India

Contacts

Public ContactDr Mudgal Kothekar MD

Sun Pharma Advanced Company Research Ltd

clinical.trials@sparcmail.com912266455645

Outcome results

None listed

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