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Safety of NGOIS Compared to BSS Plus in Pediatric Patients

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ClinicalTrials.gov Identifier: NCT00346528
Recruitment Status : Completed
First Posted : June 30, 2006
Last Update Posted : March 5, 2012
Sponsor:
Information provided by (Responsible Party):
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.

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

Study Type : Interventional  (Clinical Trial)
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 : July 2006
Actual Primary Completion Date : June 2007
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract
Drug Information available for: BSS plus
U.S. FDA Resources

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



Primary Outcome Measures :
  1. Safety Variables: Endothelial cell density, visual acuity, intraocular pressure, ocular signs and fundus assessment


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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00346528     History of Changes
Other Study ID Numbers: C-04-64
First Posted: June 30, 2006    Key Record Dates
Last Update Posted: March 5, 2012
Last Verified: March 2012

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases