NCT02132312 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Wilson ME, Trivedi RH, Plager DA
Safety and efficacy data supporting U.S. FDA approval of intracameral phenylephrine and ketorolac 1.0%/0.3% for pediatric cataract surgery: clinical safety and pupil and pain management. J Cataract Refract Surg. 2020 Jun;46(6):873-878. doi: 10.1097/j.jcrs.0000000000000194.

A Randomized, Double-Masked, Parallel-Group, Phenylephrine-Controlled Study of the Effect of OMS302 Added to Standard Irrigation Solution on Intraoperative Pupil Diameter and Acute Postoperative Pain in Children Ages Birth Through Three Years Undergoing Unilateral Cataract Extraction With or Without Lens Replacement

Details for clinical trial NCT02132312

Clinical trial NCT02132312 - References