Sodium Hyaluronate Ophthalmic Solution, 0.18% for Treatment of Dry Eye Syndrome

Alcon

Status and phase: Completed; Phase 3

Conditions: Dry Eye Syndrome

Treatments: Drug: Sodium Hyaluronate Ophthalmic Solution, 0.18%; Other: Vehicle

Study type: Interventional

Funder types: Industry

Identifiers

NCT01382225

C-09-045

Details and patient eligibility

About

The purpose of this study was to determine if Sodium Hyaluronate, 0.18% is effective in treating the signs and symptoms of dry eye disease.

Enrollment: 1,936 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Documented history of dry eyes for at least 3 months.
• Ocular discomfort due to dry eyes.
• Presence of corneal and conjunctival staining.
• Other protocol-defined inclusion criteria may apply.

Exclusion criteria

• Women who are pregnant or lactating.
• Contact lens wear within 1 week before Screening and during the study.
• Ocular surgery (of any type, including laser surgery) or ocular trauma within the 4 months prior to Screening.
• Punctal plugs or punctal occlusion initiated within 3 months of screening
• Other protocol-defined exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,936 participants in 2 patient groups, including a placebo group

Sodium Hyaluronate

Experimental group

Description:

Sodium Hyaluronate Ophthalmic Solution, 0.18%, 1-2 drops instilled in each eye 3-6 times a day for 14 days

Treatment:

Drug: Sodium Hyaluronate Ophthalmic Solution, 0.18%

Vehicle

Placebo Comparator group

Description:

Inactive ingredients, 1-2 drops instilled in each eye 3-6 times a day for 14 days

Treatment:

Other: Vehicle