A clinical Trial in patients with Steroid Responsive Inflammatory Ocular Conditions. Clinical trial is to study efficacy, safety and tolerability of Moxifloxacin HCL + Difluprednate Ophthalmic Solution V/S Moxifloxacin HCL+ Dexamethasone Phosphate Eye Drops.

A Comparative, Randomized, Double Blind, Multicentric, Prospective Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Moxifloxacin Hydrochloride 0.5% + Difluprednate 0.05% Ophthalmic Solution Vs Moxifloxacin Hydrochloride 0.5% + Dexamethasone Phosphate 0.1% Eye Drops indicated in patients for Steroid Responsive Inflammatory Ocular Conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial ocular infection exists.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/001121

Enrollment

200

Registered

2010-08-02

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: A499- Bacterial infection, unspecified Health Condition 2: null- Steroid Responsive Inflammatory Ocular Conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial ocular infection exists

Interventions

Intervention1: Moxifloxacin Hydrochloride 0.5% + Difluprednate 0.05% Ophthalmic Solution: One to Two Drops 4 times per day for the first week and twice a day for next week Control Intervention1: Moxif

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with endogenous anterior uveitis (including panuveitis) 2. Patients with 20 or more anterior chamber cell within one field of the aqueous humor (Grade 3 or higher in clinical signs and grading) as measured with a slit lamp microscope 5. Patients giving written informed consent prior to initiation of the study

Exclusion criteria

Exclusion criteria: 1. Pregnant or nursing females 2. Patients receiving systemic administration or topical administration to the head or face including instillation of corticosteroid, nonsteroidal anti-inflammatory drugs, antiphlogistic enzymes, immunosuppressive drugs or colchicines within 1 week before the initial instillation of the study drug 3. Patients with glaucoma or ocular hypertension (IOP &#8805;21 mmHg) 4. Patients with corneal erosion or corneal ulcer 5. Patients with viral keratoconjunctival diseases, tuberculos eye diseases, fungal eye diseases or bacterial eye diseases 6. Patients with diabetes mellitus 7. Patients with allergy to corticosteroids 8. Patients participating in other clinical studies within 6 months before initiation of the present study 9. Patients with sensitivity to steroids(Patients who previously exhibited increased IOP after instillation of a steroid ophthalmic solution) 10. Patients with fibrins to such an extent that might affect measurement of flare

Design outcomes

Primary

Measure	Time frame
Obsrevation of Reduction in signs & symptoms such as Redness, Irritation, Pain, Swelling and IOP.Timepoint: Day 1, Day 3, Day 7 and Day 14.;Obsrevation of Reduction in signs & symptoms such as Redness, Irritation, Pain, Swelling and IOP.Timepoint: Day 1, Day 3, Day 7 and Day 14.;Obsrevation of Reduction in signs & symptoms such as Redness, Irritation, Pain, Swelling and IOP.Timepoint: Day 1, Day 3, Day 7 and Day 14.;Obsrevation of Reduction in signs & symptoms such as Redness, Irritation, Pain, Swelling and IOP.Timepoint: Day 1, Day 3, Day 7 and Day 14.;Obsrevation of Reduction in signs & symptoms such as Redness, Irritation, Pain, Swelling and IOP.Timepoint: Day 1, Day 3, Day 7 and Day 14.;Obsrevation of Reduction in signs & symptoms such as Redness, Irritation, Pain, Swelling and IOP.Timepoint: Day 1, Day 3, Day 7 and Day 14.	—

Measure

Time frame

Obsrevation of Reduction in signs & symptoms such as Redness, Irritation, Pain, Swelling and IOP.Timepoint: Day 1, Day 3, Day 7 and Day 14.;Obsrevation of Reduction in signs & symptoms such as Redness, Irritation, Pain, Swelling and IOP.Timepoint: Day 1, Day 3, Day 7 and Day 14.;Obsrevation of Reduction in signs & symptoms such as Redness, Irritation, Pain, Swelling and IOP.Timepoint: Day 1, Day 3, Day 7 and Day 14.;Obsrevation of Reduction in signs & symptoms such as Redness, Irritation, Pain, Swelling and IOP.Timepoint: Day 1, Day 3, Day 7 and Day 14.;Obsrevation of Reduction in signs & symptoms such as Redness, Irritation, Pain, Swelling and IOP.Timepoint: Day 1, Day 3, Day 7 and Day 14.;Obsrevation of Reduction in signs & symptoms such as Redness, Irritation, Pain, Swelling and IOP.Timepoint: Day 1, Day 3, Day 7 and Day 14.

—

Secondary

Measure	Time frame
Patient satisfactionTimepoint: Day 14;Slit Lamp ObservationTimepoint: Day 1, Day 3,Day 7 and Day 14.	—

Countries

India

Contacts

Public ContactDr Shailesh Singh

Ajanta Pharma Ltd, Advent

shaileshs@ajantapharma.com022-66062112

Outcome results

None listed

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