Next Generation Ophthalmic Irrigating Solution Posterior Segment Study

Alcon

Status and phase: Completed; Phase 3

Conditions: Eye Diseases

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00333203

C-04-18

Details and patient eligibility

About

The purpose of this study is to evaluate the safety of Next Generation Ophthalmic Irrigating Solution (NGOIS) compared to BSS PLUS for use during surgery for removal of epimacular membrane and vitrectomy.

Enrollment: 369 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients of any race and sex, with an epimacular membrane who would benefit from vitrectomy and membrane removal.
• Other protocol-defined inclusion criteria may apply.

Exclusion criteria

• Under 18 years of age.
• Other protocol-defined exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single 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:

Other: BSS Plus