Health Condition 1: H269- Unspecified cataract
Conditions
Interventions
Intervention1: FDC of Tropicamide plus Phenylephrine Hydrochloride plus Lidocaine Hydrochloride Ophthalmic Solution for Injection: It is administered by an ophthalmic surgeon by injection into the eye
Sponsors
Appasamy Ocular Devices (P) Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female patients aged between 18 to 75 years (both inclusive). 2. Patients having grade 2 to 3 cataract at screening visit. 3. Patients are scheduled to undergo surgery for cataract. 4. Patients with endothelial cell count more than 2000 cell per mm2 at screening visit. 5. Patients with pupil diameter morethan or equal to 7 mm at screening visit. 6. Women of childbearing potential (WOCBP) must be using an acceptable method of contraception to avoid pregnancy throughout the study. WOCBP must have a negative urine pregnancy test at screening or baseline visit. 7. Patient with ability to understand and provide written, dated and signed informed consent form, which must have been obtained prior to screening. 8. Patients willing to comply with all the protocol requirements.
Exclusion criteria
Exclusion criteria: 1. Patients with corrected visual acuity less than 0.5. 2. Patients with refractive error with a spherical equivalent more than +6 or smaller - 6 D. 3. Patients with elevated intraocular pressure (higher than 22 mmHg). 4. Patients with current or history within two months prior to screening visit of significant ocular disease, e.g., corneal denervation, corneal epithelial defects, dry eye syndrome, ocular trauma to the operative eye, corneal edema, proliferative diabetic retinopathy in the operative eye or ocular infection. 5. Patients with the operative eye, history of chronic or recurrent inflammatory disease, e.g., iritis, scleritis, uveitis, iridocyclitis or rubeosis iritis, lens pseudoexfoliation syndrome with glaucoma or zonular compromise of congenital ocular anomaly, e.g., aniridia or congenital cataract. 6. Patients with iris atrophy in the operative eye. 7. Patients with combined surgery. 8. Patients with clinically significant ocular endothelial dysfunction. 9. Patients with history of eye surgery apart from laser trabeculoplasty less than three months previously or extraocular surgery such as strabismus surgery. 10. Patients who are using topical ocular medication influencing IOP (intraocular pressure) or pupil size within 3 months prior to screening visit. 11. Patients with nonfunctional nonoperative eye. 12. Patients with any laboratory value outside the clinically accepted reference range. 13. Patients with type 1 or uncontrolled type 2 diabetes mellitus. 14. Patients with uncontrolled hypertension with sitting systolic BP more than 140 mmHg and or diastolic BP more than 90 mmHg. 15. Patients with a history of orthostatic hypotension, fainting spells or blackout. 16. Patients with clinically relevant recent current or past history of severe, unstable, or uncontrolled cardiovascular, pulmonary, hepatic, renal, gastrointestinal, metabolic, autoimmune disease and other relevant systemic diseases or bleeding tendencies that would preclude the safe administration of the investigational product. 17. Patients who are using the following concomitant medications will not be allowed: Systemic corticoid treatments and immunosuppressive treatments within 3 months before surgery. Systemic opioids and morphinic drugs within 7 days before surgery. Topical ocular treatment with mydriatic and or anaesthetic action within 7 days before surgery. Topical treatment with anti-inflammatory and antibiotic action within 1 day before surgery (except for the preoperative treatment specified in this protocol). Anxiolytics and hypnotics on the day of surgery; adrenaline or any other agent with a mydriatic action in the intraocular irrigating solution on the day of surgery. 18. Patients with a history of central nervous system disease (such as epilepsy) or psychiatric disorders or neurological disorders. 19. Patients with known hypersensitivity to any of the topical formulation (Tropicamide, Phenylephrine and Lidocaine). 20. Patients who are using any drugs which might influence the results of the trial up to seven days prior to enrolment in the study or during the study. 21. Female patients who are pregnant or breast-feeding or expecting to conceive within the projected duration of the study. 22. Female patients who are of childbearing potential and who are neither surgic
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Change in best corrected visual acuity according to the Snellen test from baseline to end of the study visit.Timepoint: Visit 1 - Screening or Baseline visit (Day -3), Visit 3 - Follow up visit - 12 to 36 hours post-surgery, Visit 4 - Follow up visit or Week 1 (Day 7±2) and Visit 5 - End of the study visit or Week 4 (Day 28±2).;Change in endothelial cells count from baseline to end of the study visit.Timepoint: Visit 1 - Screening or Baseline visit (Day -3), Visit 3 - Follow up visit - 12 to 36 hours post-surgery, Visit 4 - Follow up visit or Week 1 (Day 7±2) and Visit 5 - End of the study visit or Week 4 (Day 28±2).;Change in intraocular pressure (IOP) from baseline to end of the study visit.Timepoint: Visit 1 - Screening or Baseline visit (Day -3), Visit 3 - Follow up visit - 12 to 36 hours post-surgery, Visit 4 - Follow up visit or Week 1 (Day 7±2) and Visit 5 - End of the study visit or Week 4 (Day 28±2).;Change in ocular pain and discomfort from baseline to end of the study visit.Timepoint: Visit 1 - Screening or Baseline visit (Day -3), Visit 2 - Enrollment visit (Day 1) - Day of Surgery, Visit 3 - Follow up visit - 12 to 36 hours post-surgery, Visit 4 - Follow up visit or Week 1 (Day 7±2) and Visit 5 - End of the study visit 0r Week 4 (Day 28±2).;Investigator’s satisfaction with study treatment as assessed on an ordinal scale at visit 2 to end of the study visit.Timepoint: Visit 2 - Enrollment visit (Day 1) - Day of Surgery, Visit 3 - Follow up visit - 12 to 36 hours post-surgery, Visit 4 - Follow up visit or Week 1 (Day 7±2) and Visit 5 - End of the study visit 0r Week 4 (Day 28±2).;Patient’s satisfaction with study medication as assessed on an ordinal scale at visit 2 to end of the study visit.Timepoint: Visit 2 - Enrollment visit (Day 1) - Day of Surgery, Visit 3 - Follow up visit - 12 to 36 hours post-surgery, Visit 4 - Follow up visit or Week 1 (Day 7±2) and Visit 5 - End of the study visit 0r Week 4 (Day 28±2).;Percentage of patients | — |
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients reporting incidences of AE and or SAE during the study and their assessment in respect to intensity, duration, pattern and causal relationship to the study medication.Timepoint: From Day 1 (i.e., Day of Surgery) to End of the study visit or Week 4 (Day 28±2). | — |
Countries
India
Contacts
Public ContactDr Rajasekhara Reddy Tamma
Clinwave Research Pvt. Ltd.
Outcome results
None listed