Safety of NGOIS Compared to BSS Plus in Pediatric Patients

Phase 3

Completed

• Conditions: Cataract
• Interventions: Drug: Next Generation Ophthalmic Irrigating Solution (NGOIS); Drug: BSS Plus

• Registration Number: NCT00346528
• Lead Sponsor: Alcon Research

Brief Summary

To evaluate the Safety of Next Generation Ophthalmic Irrigating Solution compared to BSS Plus for use during cataract surgery in Pediatric patients.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-06-28
• Study First Submitted QC: 2006-06-28
• Study First Posted: 2006-06-30
• Study Start: 2006-07
• Primary Completion: 2007-06
• Study Completion: 2007-06
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-01
• Last Update Posted: 2012-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• Cataract present.
• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria

• As per age requirements.
• Other protocol-defined exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NGOIS	Next Generation Ophthalmic Irrigating Solution (NGOIS)	-
BSS Plus	BSS Plus	-

Primary Outcome Measures

Name	Time	Method
Safety Variables: Endothelial cell density, visual acuity, intraocular pressure, ocular signs and fundus assessment

Trial Locations

Locations (1)

Contact Alcon for Trial Locations; 🇺🇸 Fort Worth, Texas, United States