Assessing Patient Comfort With Two Different Multi-Purpose Disinfecting Solutions

Not Applicable

• Conditions: Contact Lens Solution Toxicity
• Interventions: Other: RevitaLens; Other: OptiFree PureMoist

• Registration Number: NCT01847105
• Lead Sponsor: Hom, Milton M., OD, FAAO

Brief Summary

Tolerability is compared between two Multi-purpose disinfecting solutions (MPDS).

Detailed Description

According to recent surveys of contact lens fitters, the most prescribed treatments for contact lens dryness are: more frequent replacement schedule (24%), refit into different material (23%), rewetting drops (21%) and change care system (15%). Changing care systems has been a standard treatment for CL discomfort for many years. In the same survey, 30% of practitioners felt there is absolutely no difference among solutions with respect to reducing dryness and discomfort.

The investigators set out to compare the clinical performance of these two solutions: AMO's RevitaLens and Alcon's Opti-Free PureMoist.

Study Timeline

• Study First Submitted: 2013-04-24
• Status Verified: 2013-05
• Study First Submitted QC: 2013-05-01
• Study First Posted: 2013-05-06
• Last Update Submitted: 2013-05-25
• Last Update Posted: 2013-05-29
• Study Start: 2013-06
• Primary Completion: 2013-12
• Study Completion: 2014-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

1. Between the ages of 18 and over inclusive.
2. Males or females
3. Patient is in generally good & stable overall health.
4. Patient likely to comply with study guidelines & study visits.
5. Informed consent signed.
6. Are willing/able to return for all required study visits.
7. Are willing/able to follow instructions from the study investigator and his/her staff.
8. Have signed informed consent approved by Institutional Review Board or Independent Ethics Committee.

Exclusion Criteria

1. Corneal refractive surgery within 6 months of this study.
2. Intra-ocular surgery within 6 months or ocular laser surgery within 6 months.
3. Ocular pathology (includes glaucoma and cataract), which could impact results and/or place patient at risk.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
RevitaLens	RevitaLens	AMO's RevitaLens contact lens solution
RevitaLens	OptiFree PureMoist	AMO's RevitaLens contact lens solution

Primary Outcome Measures

Name	Time	Method
Self-reported comfort scores with contact lens care systems	14 days	Comfort measured by questionnaires covering positive and negative attributes of contact lens wear

Trial Locations

Locations (3)

Milton M. Hom, OD, FAAO; 🇺🇸 Azusa, California, United States

Ian Ben Gaddie, OD, FAAO.; 🇺🇸 Louisville, Kentucky, United States

Kirk L. Smick, OD, FAAO.; 🇺🇸 Morrow, Georgia, United States