Safety of NGOIS Compared to BSS Plus in Pediatric Patients

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

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 DiseaseIntervention/TreatmentPhase
  • 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

ArmIntervention/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:
N/A 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

SiteCityStateCountryPostal Code
1Contact Alcon for Trial LocationsFort WorthTexasUnited States76134

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:

Study Results

No Results Posted as of Mar 5, 2012