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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00382603
Enrollment
362
Registered
2006-09-29
Start date
2004-08-31
Completion date
2005-02-28
Last updated
2012-08-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contact Lens Care

Keywords

Contact Lens Care

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.

Interventions

Sponsors

Alcon Research
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frame
Efficacy:
Ocular Comfort and Symptom Scales
Subject Questions/Subject Likert Questionnaire
Safety:
Slit-lamp Findings - Cornea: Edema, Neovascularization, Infiltrates; Injection, Tarsal Abnormalities and Other Complications
Adverse Events

Secondary

MeasureTime frame
Average Lens Wearing Time
Corneal Fluorescein Staining (Type and Area)
Average Uncomfortable Lens Wearing Time
Lens Surface Evaluation (Lens Deposit and Lens Wettability)
Lens Replacement Incidence and Causality
Corrected Visual Acuity with Study Lenses (Snellen)
Rewetting Drop Frequency
Lens Removal Frequency

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026