NCT00315289 - 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)

Pediatric Eye Disease Investigator Group, Repka MX, Chandler DL, Beck RW, Crouch ER 3rd, Donahue S, Holmes JM, Lee K, Melia M, Quinn GE, Sala NA, Schloff S, Silbert DI, Wallace DK
Primary treatment of nasolacrimal duct obstruction with probing in children younger than 4 years. Ophthalmology. 2008 Mar;115(3):577-584.e3. Epub 2007 Nov 8.
Pediatric Eye Disease Investigator Group, Repka MX, Melia BM, Beck RW, Chandler DL, Fishman DR, Goldblum TA, Holmes JM, Perla BD, Quinn GE, Silbert DI, Wallace DK
Primary treatment of nasolacrimal duct obstruction with balloon catheter dilation in children younger than 4 years of age. J AAPOS. 2008 Oct;12(5):451-5. doi: 10.1016/j.jaapos.2008.07.001.

A Prospective Study of Primary Surgical Treatment of Nasolacrimal Duct Obstruction in Children Less Than Four Years Old

Clinical trial NCT00315289 - References