Safety and Efficacy of an Investigational Multi-Purpose Disinfecting Solution

Alcon

Status: Completed

Conditions: Healthy Contact Lens Wearers

Treatments: Device: Alcon MPDS; Device: ReNu Fresh MPS

Study type: Interventional

Funder types: Industry

Identifiers

NCT01341977

C-09-026

Details and patient eligibility

About

The purpose of this study is to determine if Alcon MPDS is safe and effective for silicone hydrogel and soft hydrogel contact lens wearers.

Full description

The purpose of this study is to determine if Alcon Multi-Purpose Disinfecting Solution (MPDS) is safe and effective for silicone hydrogel and soft hydrogel contact lens wearers.

Enrollment: 573 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Silicone hydrogel or soft contact lens wearers who wear their lenses daily wear (i.e. disinfect lenses every night).
• Patient must be able to read.
• Vision correctable to 20/30 or better with contact lenses.

Exclusion criteria

• Sensitivity to multi-purpose solutions.
• Using any topical ocular OTC or prescribed topical ocular medications.
• History or current ocular infections or ocular inflammatory events.
• Ocular surgery within the past year.
• With a medical condition or using medications that cause ocular side effects.
• Participation in any investigational study within the past 30 days.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

573 participants in 2 patient groups

Alcon MPDS

Experimental group

Description:

Alcon Multi-Purpose Disinfecting Solution (MPDS)

Treatment:

Device: Alcon MPDS

ReNu Fresh Multi-Purpose Solution

Active Comparator group

Description:

ReNu Fresh Multi-Purpose Solution

Treatment:

Device: ReNu Fresh MPS