Phase III clinical study evaluates the efficacy and safety of a combination eye drop containing Moxifloxacin/Nepafenac compared to Moxifloxacin/Ketorolac for patients with Inflammatory Ocular Conditions
- Conditions
- Health Condition 1: H200- Acute and subacute iridocyclitisHealth Condition 2: H16- KeratitisHealth Condition 3: H150- Scleritis
- Registration Number
- CTRI/2024/08/071785
- Lead Sponsor
- Akums Drugs & Pharmaceuticals Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. Adult male and female subjects, 18 years to 60 years of age (both inclusive).
2. Patients with current inflammatory eye disease (i.e., uveitis, scleritis, keratitis) in either eye as diagnosed using slit lamp Biomicroscopy.
3. Patients with ocular inflammation including who have undergone cataract surgery, vitreous surgery or both (including patients who have undergone IOL insertion surgery).
4. Patients with Anterior chamber cell grade = 1+ based on Standardization of Uveitis Nomenclature (SUN) criteria.
5. Patients with Intraocular Pressure (IOP ? 20 mmHg).
6. Patients who are able to understand and give voluntary, written informed consent to participate in this clinical investigation and from whom written consent has been obtained.
7. Patients shall be willing and able to understand and comply with the requirements of the study, administer the study medication as instructed, return for the required treatment period visits, comply with therapy prohibitions, and be able to complete the study.
8. Female Patients, of child-bearing potential practicing an acceptable method of birth control such as sexual abstinence, intrauterine device IUD, birth control pills, a double-barrier method, transdermal, injection or implants, non-hormonal or hormonal, condom plus spermicide, diaphragm plus spermicide, or vaginal spermicidal suppository; for the duration of the study as judged by the investigator(s)/study physician and agree to follow the same should be used during treatment.
OR
Postmenopausal for at least 1 year
OR
Surgically sterile (bilateral tubal ligation/bilateral oophorectomy/ hysterectomy has been performed on the Subject).
1. Documented/suspected history of hypersensitivity to the study medications or any of the ingredients of the formulation.
2. Patients who took systemic administration of corticosteroids or immunosuppressive agents, or used ophthalmic ointments of corticosteroids within 1 week before instillation of the drugs.
3. Patients who underwent local injection of corticosteroids in the eyes before instillation of the investigational drugs; (patients who used aqueous preparations within 1 week or patient who used depot preparations within 2 weeks will be excluded)
4. Patients with summed ocular inflammation score
5. Patients who took systemic administration of non-steroidal anti-inflammatory agents or anti-inflammatory enzyme preparations within 3 days before instillation of the investigational drugs.
6. Patients who instilled non-steroidal anti-inflammatory agents within 24 hours before the screening period.
7. Patients who underwent sub-conjunctival or intravitreal injection.
8. Patients who have intraocular hemorrhage with a degree that may affect the postoperative evaluations.
9. Patients who underwent gas tamponade at the surgery.
10. Patients with endogenous uveitis.
11. Patients having corneal epithelial detachment or corneal ulcer in the target eye.
12. Patients who are required to wear contact lens during the study period.
13. Patients who are scheduled to undergo surgery of the opposite eye during the study period.
14. Patients with Concurrent use of any topical ophthalmic medications other than the study intervention during the course of the study.
15. Patients with Concurrent use of temporary or permanent punctual plugs or history of punctual cautery in one or both eyes.
16. Patients with Current enrolment in an investigational drug or device study or participation in such a study within 30 days of entry into this study.
17. Patients with participation in a blood or plasma donation program within 30 days prior to the study intervention administration.
18. Patients with severe dry eye disease.
19. Subjects with Covid 19 signs and symptoms during screening will be excluded in the study.
20. Females who are pregnant, nursing or planning a pregnancy during the study.
21. Patients with documented history of clinically significant or progressive retinal disease (e.g., retinal degeneration, diabetic retinopathy, retinal detachment) in either eye.
22. Patients with documented history of ocular trauma = 6 months before the study.
23. Patients with severe illness or other condition that would make the patient unsuitable for the study, as per investigator discretion.
24. Patients with active or prior severe, unstable, or uncontrolled cardiovascular, cerebrovascular, hepatic, or renal disease.
25. Patients with clinically significant impaired hepatic function (SGOT and SGPT more than 3X the UNL and/or Total bilirubin more than 2 X the UNL) at screening.
26. Currently taking prohibited concomitant medications(s) like local or systemic Corticosteroids, Anti-vascular endothelial growth factor (anti-VEGF) therapy and inability/unwillingness to discontinue them for the entire study period.
27. Patients who are known seropositive cases of HIV, Hepatitis B or Hepatitis C.
28. Patients who have a recent history or who are currently known to abuse alcohol or drugs. <br/
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of patients showing improvement in ocular inflammation using slit lamp biomicroscopyTimepoint: From baseline Visit 2 and day 7.
- Secondary Outcome Measures
Name Time Method 1. Evaluate the percentage of patients with symptoms of ocular inflammation which includes pain, photophobia & watering at Day 1, 3 & 7. <br/ ><br> <br/ ><br>2.Percentage of patients showing improvement in aqueous flare using slit lamp biomicroscopy using Standardization of Uveitis Nomenclature (SUN) criteria from baseline & day 7. <br/ ><br> <br/ ><br>3.Percentage of patients showing improvement in Conjunctival Hyperemia from baseline to Day 3 & Day 7.Timepoint: 1. At Day 1, 3 & 7. <br/ ><br>2. From baseline & day <br/ ><br>3. From baseline to Day 3 & Day 7.