Performance and Acceptance of Optive Versus Hylocomod Eyedrops in Patients With Dry Eye Symptoms

Allergan

Status and phase: Completed; Phase 4

Conditions: Dry Eye Syndromes

Treatments: Drug: A sterile solution containing sodium carboxymethylcellulose and glycerin, preserved with PURITE®; Drug: Sodium hyaluronate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00761202

AGN/OPH/DE/002

Details and patient eligibility

About

This study evaluates the performance and acceptance of Optive versus Hylocomod eyedrops, when administered for one month to patients with mild to moderate dry eye symptoms, with and without contact lenses.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years or over
• Contact lens wearer, spectacle wearer or non-spectacle wearer
• Mild to severe dry eye symptoms, defined as OSDI score 13 to 100
• Mild to moderate conjunctival staining in each eye and/or mild to moderate corneal staining in each eye
• Best corrected visual acuity of 6/9 in each eye

Exclusion criteria

• Previously used Hylocomod or Optive eyedrops
• Systemic allergy or eye allergy
• Systemic disease which might have an ocular component and/or interfere with contact lens wear
• Autoimmune disease which might have an ocular component and/or interfere with contact lens wear
• Systemic medication which might have eye side effects and or interfere with contact lens wear
• Eye infection or use of eye medication

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

1

Active Comparator group

Description:

Optive Eyedrops

Treatment:

Drug: A sterile solution containing sodium carboxymethylcellulose and glycerin, preserved with PURITE®

2

Active Comparator group

Description:

Hylocomod Eyedrops

Treatment:

Drug: Sodium hyaluronate