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Safety of NGOIS Compared to BSS Plus in Pediatric Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00346528
First received: June 28, 2006
Last updated: March 1, 2012
Last verified: March 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Cataract
 Drug: Next Generation Ophthalmic Irrigating Solution (NGOIS)
Drug: BSS Plus
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Safety of NGOIS Compared to BSS Plus in Pediatric Patients

Resource links provided by NLM:

MedlinePlus related topics: Cataract
U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Safety Variables: Endothelial cell density, visual acuity, intraocular pressure, ocular signs and fundus assessment [ Designated as safety issue: Yes ]

Enrollment: 18
Study Start Date: July 2006
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   up to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00346528

Locations
United States, Texas
Contact Alcon for Trial Locations
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Stephen Lane Medical Monitor
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00346528     History of Changes
Other Study ID Numbers: C-04-64
Study First Received: June 28, 2006
Last Updated: March 1, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on May 23, 2013