Evaluation of the Effect of Repeated Usage on the Tear Film Characteristics of an Investigational Eye Drop in Dry Eye Sufferers

Optometric Technology Group

Status and phase: Completed; Phase 3; Phase 2

Conditions: Dry Eye Syndrome

Treatments: Device: Carboxymethylcellulose sodium, glycerin and polysorbate 80

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01339936

AG9965-005 ID 10-12

Details and patient eligibility

About

The main objectives of the investigation will be to assess the effect of the repeated usage of an investigational eye drop on the tear film characteristics of dry eye sufferers and demonstrate the benefit of this eye drops for dry eye sufferers.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Mild or greater dry eye symptoms.
• Evidence of evaporative dry eye

Exclusion criteria

• Known allergy or sensitivity to the study product(s) or its components
• Current contact lens wearer
• Systemic or ocular allergies
• Use of systemic medication which might have ocular side effects.
• Any ocular infection.
• Use of ocular medication.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Investigational eye drop

Experimental group

Description:

Formulation 1: Carboxymethylcellulose sodium, glycerin and polysorbate 80 based eye drops formulated for the relief of ocular surface irritation and symptoms of dryness

Treatment:

Device: Carboxymethylcellulose sodium, glycerin and polysorbate 80