Assessing Patient Comfort With Two Different Multi-Purpose Disinfecting Solutions

Contact Lens Solution Toxicity Clinical Trial

Official title:

Assessing Patient Comfort in Silicone Hydrogel Contact Lenses When Cleaned and Stored in Two Different Multi-Purpose Disinfecting Solutions

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01847105
• Other study ID #: 12-GHS Comfort Study
• Status: Enrolling by invitation
• Phase: N/A
• First received: April 24, 2013
• Last updated: May 25, 2013
• Start date: June 2013
• Est. completion date: May 2014

Study information

• Verified date: May 2013
• Source: Hom, Milton M., OD, FAAO
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 54
• Est. completion date: May 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Contact Lens Solution Toxicity

Intervention

Other:
• RevitaLens
Multi-purpose disinfecting solution
• OptiFree PureMoist
Multi-purpose disinfecting solution

Locations

Country	Name	City	State
United States	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

Sponsors (2)

Lead Sponsor	Collaborator
Hom, Milton M., OD, FAAO	Abbott Medical Optics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-reported comfort scores with contact lens care systems	Comfort measured by questionnaires covering positive and negative attributes of contact lens wear	14 days	No