The purpose of this study is to evaluate efficacy and safety of the ophthalmic solution PRO-155 in patients post phacoemulsification.
Postsurgical inflammation is an inevitable condition after cataract surgery. The use of non-steroidal anti-inflammatory drugs is a safe option for treating ocular inflammation. This is a phase II randomized double-blind clinical trial. The aim is to compare and to evaluate efficacy and safety of two ophthalmic solutions in patients post phacoemulsification. Patients will be randomized to receive either PRO-155 or Nevanac for 60 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
160
Hospital Civil de Guadalajara Fray Antonio Alcalde
Guadalajara, Jalisco, Mexico
Percentage of Cellularity in Anterior Chamber
Change from Percentage of Cellularity in anterior chamber after 30 days of treatment.
Time frame: day 30
Flare in Anterior Chamber
Percentage of Participants with flare in anterior chamber after 30 days of treatment
Time frame: day 30
Percentage of Patients Without Ocular Pain
percentage of patients without pain, would be measured using the Visual Analog Pain Scale
Time frame: day 30
Mean Aqueous Concentration of Intervention Drug
a nurse was instructed to instill five drops of the research product into each patient's eye in the hour before surgery. The concentration of the drug was determined for aqueous humor sample (0.15 mL) with a 30-gauge needle on a TB syringe after completion of the paracentesis. The paracentesis was performed after first incision during the phacoemulsification.
Time frame: before surgery
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.