Efficacy and Safety of PRO-155 Versus Nevanac in Post Phacoemulsification

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01657266
• Other study ID #: SOPH155-0412/II
• Status: Completed
• Phase: Phase 2
• Start date: December 2013
• Est. completion date: April 2015

Study information

• Verified date: February 2018
• Source: Laboratorios Sophia S.A de C.V.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate efficacy and safety of the ophthalmic solution PRO-155 in patients post phacoemulsification.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: April 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

• 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

Related Conditions & MeSH terms

• Cataract
• Phacoemulsification Cataract Surgery

Intervention

Drug:
• PRO-155
Pre-medication (before surgery) and maintenance treatment.
• Nevanac
Pre-medication (before surgery) and maintenance treatment.

Locations

Country	Name	City	State
Mexico	Hospital Civil de Guadalajara Fray Antonio Alcalde	Guadalajara	Jalisco

Sponsors (1)

Lead Sponsor	Collaborator
Laboratorios Sophia S.A de C.V.

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Epithelial Defects Detected With Fluorescein	The percentage of patients presenting epithelial defects with fluorescein staining will be evaluated	measurements will be made at days 1, 5, 7 and 30
Other	Epithelial Defects Detected With Green Lissamine	the percentage of patients presenting epithelial defects evaluated with green lysine will be reported	measurements will be made at days 1, 5, 7 and 30
Other	Intraocular Pressure	Change from Baseline in the intraocular pressure after 30 days of treatment	day 30
Other	Retinal Thickness	Change from Baseline in retinal thickness after 30 days of treatment. A third measurement will be done at 60 day after day surgery.	day 30 and 60
Primary	Percentage of Cellularity in Anterior Chamber	Change from Percentage of Cellularity in anterior chamber after 30 days of treatment.	day 30
Primary	Flare in Anterior Chamber	Percentage of Participants with flare in anterior chamber after 30 days of treatment	day 30
Secondary	Percentage of Patients Without Ocular Pain	percentage of patients without pain, would be measured using the Visual Analog Pain Scale	day 30
Secondary	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.	before surgery

External Links

•   Palacio C, et al. Bromfenac 0.09% bioavailability in aqueous humor, prophylactic effect on cystoid macular edema, and clinical signs of ocular inflammation after phacoemulsification in a Mexican population. Clinical Ophthalmology 2016;10:233-237