Phase 2
N=148
Efficacy and Safety of PRO-155 Versus Nevanac in Post Phacoemulsification
Cataract · Phacoemulsification Cataract Surgery
Bottom Line
View on ClinicalTrials.gov: NCT01657266 ↗Enrolled (actual)
148
Serious AEs
1.4%
Results posted
Oct 2018
Primary outcome: Primary: Percentage of Cellularity in Anterior Chamber — 64.2; 64.3; 0; 0 Percentage of Cellularity — p=1.00
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- PRO-155 (Drug); Nevanac (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Laboratorios Sophia S.A de C.V.
- Primary completion
- Mar 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Cellularity in Anterior Chamber |
64.2; 64.3; 0; 0 | 1.00 |
| PRIMARY Flare in Anterior Chamber |
31.4; 31.5; 0; 0 | — |
| SECONDARY Percentage of Patients Without Ocular Pain |
6.1; 5.7; 1.5; 1.6 | — |
| SECONDARY Mean Aqueous Concentration of Intervention Drug |
207.5; 314.4 | — |
Summary
The purpose of this study is to evaluate efficacy and safety of the ophthalmic solution PRO-155 in patients post phacoemulsification.
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 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
- Patients with history of hypersensitivity or contraindication for any drug used in the study
- Patients under anticoagulant treatment
- Contact lens users
- Pregnant patients, at risk of pregnancy or breastfeeding
- Patients without birth control treatment
- Patients with any active toxicomania (alcoholism, cigarette, cannabis or others)
- Patients who had participated in any clinical trial in the last 90 days
- Legal or mentally disabled patients who could not give informed consent
- Patients who cannot comply with all study requirements
Data sourced from ClinicalTrials.gov (NCT01657266). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.