Safety of NGOIS Compared to BSS Plus in Pediatric Patients

Cataract Clinical Trial

Official title:

Safety of NGOIS Compared to BSS Plus in Pediatric Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00346528
• Other study ID #: C-04-64
• Status: Completed
• Phase: Phase 3
• First received: June 28, 2006
• Last updated: March 1, 2012
• Start date: July 2006
• Est. completion date: June 2007

Study information

• Verified date: March 2012
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: June 2007
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 17 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataract

Intervention

Drug:
• Next Generation Ophthalmic Irrigating Solution (NGOIS)
Volume sufficient to irrigate adequately during cataract surgery
• BSS Plus
Volume sufficient to irrigate adequately during cataract surgery

Locations

Country	Name	City	State
United States	Contact Alcon for Trial Locations	Fort Worth	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety Variables: Endothelial cell density, visual acuity, intraocular pressure, ocular signs and fundus assessment			Yes