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.
- Conditions
- Health Condition 1: A499- Bacterial infection, unspecifiedHealth 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
- Registration Number
- CTRI/2010/091/001121
- Lead Sponsor
- Ajanta Pharma Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
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
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 ≥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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Patient satisfactionTimepoint: Day 14;Slit Lamp ObservationTimepoint: Day 1, Day 3,Day 7 and Day 14.