NCT00346528
Completed
Phase 3
Safety of NGOIS Compared to BSS Plus in Pediatric Patients
ConditionsCataract
Overview
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Alcon Research
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Safety Variables: Endothelial cell density, visual acuity, intraocular pressure, ocular signs and fundus assessment
Overview
Brief Summary
To evaluate the Safety of Next Generation Ophthalmic Irrigating Solution compared to BSS Plus for use during cataract surgery in Pediatric patients.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 1 Week to 17 Years (Child)
- Sex
- 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.
Arms & Interventions
NGOIS
Experimental
Intervention: Next Generation Ophthalmic Irrigating Solution (NGOIS) (Drug)
BSS Plus
Active Comparator
Intervention: BSS Plus (Drug)
Outcomes
Primary Outcomes
Safety Variables: Endothelial cell density, visual acuity, intraocular pressure, ocular signs and fundus assessment
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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