Safety and Efficacy of an Artificial Tear for the Treatment of Dry Eye

Allergan

Status: Completed

Conditions: Dry Eye Syndrome

Treatments: Drug: Carboxymethylcellulose and Glycerin based artificial tear; Drug: Carboxymethylcellulose

Study type: Interventional

Funder types: Industry

Identifiers

NCT00514852

AG9818-002

Details and patient eligibility

About

The efficacy, safety and acceptability of a new artificial tear in subjects with dry eye will be compared to a currently-available artificial tear

Enrollment: 316 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Mild, moderate or Severe Symptoms of Dry Eye

Exclusion criteria

• Uncontrolled systemic disease
• Use of systemic medications affecting dry eye
• Pregnancy or planning a pregnancy
• Contact lens wear

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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316 participants in 2 patient groups

1

Experimental group

Description:

Carboxymethylcellulose and Glycerin based artificial tear

Treatment:

Drug: Carboxymethylcellulose and Glycerin based artificial tear

2

Active Comparator group

Description:

Carboxymethylcellulose

Treatment:

Drug: Carboxymethylcellulose