Safety and Efficacy of Next Generation Ophthalmic Irrigating Solution Compared to BSS Plus

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

NCT00333268

C-04-14

Details and patient eligibility

About

The purpose of this study is to determine the safety and efficacy of Next Generation Ophthalmic Irrigating Solution (NGOIS) compared to BSS Plus for use during cataract extraction and intra-ocular lens (IOL) implantation.

Enrollment: 369 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients any race or sex 18 or older and undergoing cataract extraction with planned implantation of a posterior chamber intraocular lens.
• Other protocol-defined inclusion criteria may apply.

Exclusion criteria

• Under 18
• 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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369 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