Phase 2 Randomized, Double-blind Clinical Trial to Evaluate Efficacy and Safety of the Ophthalmic Solution PRO-155 Versus Nevanac 0.1% Ophthalmic Solution in Post Phacoemulsification Patients
Overview
- Phase
- Phase 2
- Intervention
- Nevanac
- Conditions
- Cataract
- Sponsor
- Laboratorios Sophia S.A de C.V.
- Enrollment
- 160
- Locations
- 1
- Primary Endpoint
- Flare in Anterior Chamber
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
The purpose of this study is to evaluate efficacy and safety of the ophthalmic solution PRO-155 in patients post phacoemulsification.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients older than 18 years who require cataract surgery
- •Both genders
- •Provide informed consent
- •Normal Laboratory results
Exclusion Criteria
- •Patients with visual acuity of 20/40 or less in the contralateral eye of the surgery
- •Patients with any trans-surgical complication
- •Patients with a cataract \>NC4, C4 or P4 classified with the system LOCS
- •Patients with any active corneal pathology
- •Patients under any steroidal treatment (topic, systemic or inhaled)14 days prior surgery or NSAIDs 7 days before the surgery (except low-dose aspirin)
- •Patients with IOP \<5 or \>21 mmHg
- •Patients that have ocular pain, cellularity or flare at the moment of selection
- •Patients with ocular exfoliation, trauma or any inflammatory disease
- •Patients with diabetic retinopathy that need treatment or uncontrolled diabetes mellitus
- •Patients who are planning cataract surgery of the contralateral eye 14 days after surgery of the study eye
Arms & Interventions
Nevanac
Nepafenac 0.1% (1mg/mL) Ophthalmic Suspension Pre-medication: 1 drop each 15 minutes during 1 hour before surgery in the affected eye Maintenance therapy: 1 drop 3 times a day for 30 days
Intervention: Nevanac
PRO-155
Bromfenac 0.09% (0.9mg/mL) Ophthalmic solution Pre-medication: 1 drop each 15 minutes during 1 hour before surgery in the affected eye Maintenance therapy: 1 drop 3 times a day for 30 days
Intervention: PRO-155
Outcomes
Primary Outcomes
Flare in Anterior Chamber
Time Frame: day 30
Percentage of Participants with flare in anterior chamber after 30 days of treatment
Percentage of Cellularity in Anterior Chamber
Time Frame: day 30
Change from Percentage of Cellularity in anterior chamber after 30 days of treatment.
Secondary Outcomes
- Percentage of Patients Without Ocular Pain(day 30)
- Mean Aqueous Concentration of Intervention Drug(before surgery)