Health Condition 1: H590- Disorders of the eye following cataract surgery
Conditions
Interventions
Intervention1: FDC of Moxifloxacin 0.5% w/v plus Nepafenac 0.1 % w/v Ophthalmic Solution: 1 drop of FDC of Moxifloxacin 0.5% w/v plus Nepafenac 0.1 % w/v Ophthalmic Solution three times a day for 15 d
Sponsors
Ajanta Pharma Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female subjects with 18 to 65 years of age (both inclusive). 2. Subjects who will undergo uncomplicated Phacoemulsification surgery. 3. The subjects who are willing to sign written informed consent for participation in the study. 4. Subjects willing to adhere to all protocol procedures.
Exclusion criteria
Exclusion criteria: 1. Suspected or history of hypersensitivity to either of the study medications or any of the formulation ingredients. 2. Subjects who received corticosteroid systemic administration, immunosuppressive medication, or corticosteroid ophthalmic ointments within a week before the administration of the investigational medications. 3. Subjects who underwent local injection of corticosteroids in the eyes before instillation of the investigational drugs; (patients who used aqueous preparations within 1 week or subjects who used depot preparations within 2 weeks will be excluded). 4. Subjects who received systemic administration of anti-inflammatory enzyme preparations or non-steroidal anti-inflammatory medicines within three days prior to the administration of investigational drugs. 5. Subjects who instilled corticosteroids, non-steroidal anti-inflammatory drugs, or preparations containing anti-inflammatory enzymes less than 24 hours before the pre-instillation observation. 6. Subjects who underwent perioperative and/or postoperative intravitreous injection of corticosteroids. 7. Subjects treated with sub-conjunctival injections. 8. Subjects who have intraocular hemorrhage with a degree that may affect the postoperative evaluations. 9. Subjects who underwent gas tamponade at the surgery. 10. Subjects with endogenous uveitis. 11. Subjects having corneal epithelial detachment or corneal ulcer in the target eye. 12. Subjects who are suspected of having viral, bacterial or mycotic keratoconjunctivitis in the target or opposite eye. 13. Subjects with glaucoma or ocular hypertension. 14. Subjects showing IOP not less than 25 mmHg after surgery. 15. Subjects who are required to wear contact lens during the study period. 16. Subjects who are scheduled to undergo surgery of the opposite eye during the study period 17. Female subjects who are pregnant or lactating or planning to become pregnant during the study. 18. Females who are not ready to use acceptable contraceptive methods during the course of study. 19. Concurrent participation in another clinical trial or any investigational therapy within 90 days prior to signing informed consent. 20. Participant has a clinically significant disorder that, in the opinion of the investigator, would result in the participantâ??s inability to understand and comply with the requirements of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Anterior chamber (AC) inflammation, by slit-lamp according to a standard scoring system, will be used as the primary efficacy parameterTimepoint: Day 15 | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in intensity of pain from the baseline to Day 15 as assessed by a VAS Scale. Safety Parameter: 1 The assessment of safety will be based on the frequency of Adverse Events & Changes in laboratory parameters. 2 IOP & Visual Acuity will be measured at every visit to assess adverse effect of drug. Timepoint: Day 15 | — |
Countries
India
Contacts
Public ContactDr Ravindra Mote
Mediclin Clinical Research
Outcome results
None listed