A Trial Evaluating Patient Preference of Dropless vs Drops Post Cataract Surgery
To evaluate the safety and ocular efficacy of Dextenza in combination with an intracameral antibiotic and NSAID in controlling post-operative ocular pain and inflammation compared to standard of care topical therapy in patients undergoing bilateral cataract surgery.
| Condition(s) | Patient Preference |
|---|---|
| Status | Recruiting |
| Phase | Phase 4 |
| Study type | Interventional |
| Summary | To evaluate the safety and ocular efficacy of Dextenza in combination with an intracameral antibiotic and NSAID in controlling post-operative ocular pain and inflammation compared to standard of care topical therapy in patients undergoing bilateral cataract surgery. |
| Who can participate | Inclusion Criteria: * A male or female subject in good general health (as determined by the Investigator), \> 22 years of age at the time of the screening visit * A subject must be willing and able to sign informed consent * A woman of child-bearing potential must not be pregnant or lactating, must have a negative pregnancy test at screening and must be practicing an adequate method of birth control. Acceptable methods of birth control include intrauterine device (IUD), oral, dermal ("patch"), implant or injected contraceptives; tubal ligation; and barrier methods with spermicide. * A subject has the availability, willingness and sufficient cognitive awareness to comply with exam procedures and able to return for all scheduled study visits * A subject with a cataract for which routine phac |
| Ages | 22 Years to 100 Years |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | Ophthalmic Consultants of Long Island |
| Locations | Garden City, New York, United States |
| Start date | 2019-11-04 |
| NCT ID | NCT04205916 |
| Official listing | https://clinicaltrials.gov/study/NCT04205916 |