Safety of NGOIS Compared to BSS Plus in Pediatric Patients

Alcon

Status and phase: Completed; Phase 3

Conditions: Cataract

Treatments: Drug: Next Generation Ophthalmic Irrigating Solution (NGOIS); Drug: BSS Plus

Study type: Interventional

Funder types: Industry

Identifiers

NCT00346528

C-04-64

Details and patient eligibility

About

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

Enrollment: 18 patients

Sex: All

Ages: 1 week to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Cataract present.
• Other protocol-defined inclusion criteria may apply.

Exclusion criteria

• As per age requirements.
• Other protocol-defined exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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18 participants in 2 patient groups

NGOIS

Experimental group

Treatment:

Drug: Next Generation Ophthalmic Irrigating Solution (NGOIS)

BSS Plus

Active Comparator group

Treatment:

Drug: BSS Plus