Safety of NGOIS Compared to BSS Plus in Pediatric Patients

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00346528
• Collaborator: (none)
• Enrollment: 18
• Location: 1
• Arms: 2
• Duration (Months): 11
• Patients Per Site Per Month: 1.6

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Cataract	Drug: Next Generation Ophthalmic Irrigating Solution (NGOIS); Drug: BSS Plus	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 18 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Safety of NGOIS Compared to BSS Plus in Pediatric Patients
• Study Start Date: Jul 1, 2006
• Actual Primary Completion Date: Jun 1, 2007
• Actual Study Completion Date: Jun 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: NGOIS	Drug: Next Generation Ophthalmic Irrigating Solution (NGOIS); Volume sufficient to irrigate adequately during cataract surgery
Active Comparator: BSS Plus	Drug: BSS Plus; Volume sufficient to irrigate adequately during cataract surgery

Outcome Measures

Primary Outcome Measures

1. Safety Variables: Endothelial cell density, visual acuity, intraocular pressure, ocular signs and fundus assessment []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Week to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Cataract present.

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• As per age requirements.

• Other protocol-defined exclusion criteria may apply.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Contact Alcon for Trial Locations	Fort Worth	Texas	United States	76134

Sponsors and Collaborators

• Alcon Research

Investigators

• Study Director: Stephen Lane, Medical Monitor

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT00346528
• Other Study ID Numbers: C-04-64
• First Posted: Jun 30, 2006
• Last Update Posted: Mar 5, 2012
• Last Verified: Mar 1, 2012

• Additional relevant MeSH terms: Cataract

Study Results

No Results Posted as of Mar 5, 2012