Comparison of OPTI-FREE RepleniSH and ReNu Multi-Plus Lens Care Regimens on Corneal Epithelium

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00724269
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Duration (Months): 21
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the corneal epithelium after soft contact lens wear and use of two marketed multi-purpose solutions.

Condition or Disease	Intervention/Treatment	Phase
Contact Lens Wear	Device: OPTI-FREE RepleniSH; Device: ReNu MultiPlus MPS	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Investigator)
• Primary Purpose: Screening
• Study Start Date: Oct 1, 2009
• Actual Primary Completion Date: Jul 1, 2011
• Actual Study Completion Date: Jul 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Opti Free RepliniSH Opti Free RepliniSH	Device: OPTI-FREE RepleniSH; Multi-Purpose Solution for soft contact lenses
Active Comparator: ReNu Multi-Plus ReNu Multi-Plus	Device: ReNu MultiPlus MPS; Multi-Purpose Solution for soft contact lenses

Outcome Measures

Primary Outcome Measures

1. Confocal microscopy analysis of Corneal Epithelium [2 weeks]

Secondary Outcome Measures

1. Patient comfort [2 weeks]

2. Corneal Staining [2 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Successful contact lens wear on a daily wear basis

• Wear contact lenses at least 8 hours/day

• Vision correctable to at least 20/30

• Normal Eyes

• Other protocol-defined inclusion criteria may apply

Exclusion:

• Topical ocular medication use

• Other protocol-defined inclusion criteria may apply

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Contact Alcon Call Center for Study Locations	Fort Worth	Texas	United States	76134

Sponsors and Collaborators

• Alcon Research

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT00724269
• Other Study ID Numbers: SMA-08-04 / BP-08-01
• First Posted: Jul 29, 2008
• Last Update Posted: Oct 1, 2012
• Last Verified: Nov 1, 2011

• Keywords provided by Alcon Research: Contact lens wear; multi-purpose solution; corneal staining

Study Results

No Results Posted as of Oct 1, 2012