Evaluation of an Investigational Multi-Purpose Disinfecting Solution for the Care of Soft Contact Lenses in Symptomatic Patients

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00382603
• Collaborator: (none)
• Enrollment: 362
• Location: 1
• Duration (Months): 6
• Patients Per Site Per Month: 59.9

Study Details

Study Description

Brief Summary

The objective of the study was to clinically evaluate the safety and effectiveness of a new multi-purpose disinfecting solution for soft contact lenses in patients who experience discomfort with their contact lenses.

Condition or Disease	Intervention/Treatment	Phase
Contact Lens Care	Device: OptiFree Multi-Purpose Disinfecting Solution	N/A

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: Clinical Evaluation of the Safety and Efficacy of an Investigational Multi-Purpose Disinfecting Solution Compared to a Marketed Multi-Purpose Solution for Care of Soft Contact Lenses in Symptomatic Patients
• Study Start Date: Aug 1, 2004
• Actual Primary Completion Date: Feb 1, 2005
• Actual Study Completion Date: Feb 1, 2005

Outcome Measures

Primary Outcome Measures

1. Efficacy: []

2. Ocular Comfort and Symptom Scales []

3. Subject Questions/Subject Likert Questionnaire []

4. Safety: []

5. Slit-lamp Findings - Cornea: Edema, Neovascularization, Infiltrates; Injection, Tarsal Abnormalities and Other Complications []

6. Adverse Events []

Secondary Outcome Measures

1. Corneal Fluorescein Staining (Type and Area) []

2. Lens Surface Evaluation (Lens Deposit and Lens Wettability) []

3. Lens Replacement Incidence and Causality []

4. Corrected Visual Acuity with Study Lenses (Snellen) []

5. Rewetting Drop Frequency []

6. Lens Removal Frequency []

7. Average Lens Wearing Time []

8. Average Uncomfortable Lens Wearing Time []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Symptomatic for contact lens related discomfort at the end of the lens wearing day.

• Successful daily wear of FDA Group IV lenses on a two-week or longer replacement schedule for at least two weeks.

• Use of a multi-purpose solution only as the pre-study care regimen for at least one month (rewetting drops use is also acceptable).

• Successful lens wear for at least 4 hours per day.

• Vision correctable to 20/30.

• Normal eyes - no current ocular abnormalities that prevent successful contact lens wear.

• No corneal surgery within the past 12 months.

• No systemic disease that affects that eye or that could be worsened by the use of contact lenses or solutions.

• No over-the-counter or prescription ocular medication.

• No enrollment in another clinical study within 30 days prior to enrollment.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Highlands Ranch	Highlands Ranch	Colorado	United States	80126

Sponsors and Collaborators

• Alcon Research

Investigators

• Study Director: Leslie Napier, Alcon Research

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT00382603
• Other Study ID Numbers: C-04-09
• First Posted: Sep 29, 2006
• Last Update Posted: Aug 16, 2012
• Last Verified: Sep 1, 2006

• Keywords provided by Alcon Research: Contact Lens Care

Study Results

No Results Posted as of Aug 16, 2012