Efficacy Study of a New Eyedrop on Silicone Hydrogel Contact Lens Wearers With Dry Eye Complaints

Optometric Technology Group

Status and phase: Completed; Phase 4

Conditions: Contact Lens Related Dry Eye Syndrome

Treatments: Device: OPTIVEtm Plus; Procedure: No treatment; Device: Blink Contacts® Eye Drops

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01543061

AG9965-006 ID 11-19

Details and patient eligibility

About

The objectives of the investigation will be to assess the effect of the repeated usage of a new eye drop on the tear film characteristics of silicone hydrogel contact lens wearers with contact lens related comfort problems and to quantify any potential benefit.

Enrollment: 35 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Current silicone hydrogel contact lens wearer
• Complaints of contact lens related dry eye (Symptoms and reduced comfortable wearing time)

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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35 participants in 3 patient groups, including a placebo group

New study eye drop

Active Comparator group

Description:

One month of contact lens wear with use of the Test study eye drops

Treatment:

Device: OPTIVEtm Plus

No Eyedrop

Placebo Comparator group

Description:

One month of contact lens wear with no eye drop use

Treatment:

Procedure: No treatment

BLINK Contacts Lubricating eye drop

Active Comparator group

Description:

One month of contact lens wear with use of the Control study eye drops

Treatment:

Device: Blink Contacts® Eye Drops