Evaluation of an Investigational Multi-Purpose Solution (MPS)

Abbott

Status and phase: Completed; Phase 3

Conditions: Study Focus is Healthy Contact Lens Wearers

Treatments: Device: Investigational MPS; Device: Opti-Free

Study type: Interventional

Funder types: Industry

Identifiers

NCT00961051

COBR-105-9608

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and effectiveness of an investigational multi-purpose contact lens solution.

Full description

A new multi-purpose solution has been developed for optimal lens disinfection and lens wearing comfort, compatible with a wide variety of commercially available lenses. Ten investigative sites were selected to evaluate 274 soft contact lens wearers in a parallel group study of one investigational multi-purpose solution and one marketed predicate solution.

Enrollment: 270 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Have successfully worn hydrogel contact lenses of the same material to be worn during the study
• Have normal eyes (with the exception of unaided visual acuity)
• Have successfully used a multi-purpose contact lens care solution
• Have acceptable visual acuity and lens wearing comfort at time of enrollment

Exclusion criteria

• Concurrently enrolled another clinical trial
• Have a known sensitivity to any study product ingredient(s)
• Have a condition that may put them at significant risk

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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270 participants in 2 patient groups

Investigational MPS

Experimental group

Description:

Investigational multipurpose disinfecting solution (study MPS)

Treatment:

Device: Investigational MPS

Predicate MPS

Active Comparator group

Description:

Opti-Free RepleniSH multipurpose disinfecting solution (predicate MPS)

Treatment:

Device: Opti-Free