Assessing Patient Comfort With Two Different Multi-Purpose Disinfecting Solutions

• Sponsor: Hom, Milton M., OD, FAAO (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01847105
• Collaborator: Abbott Medical Optics (Industry)
• Enrollment: 54
• Locations: 3
• Arm: 1
• Duration (Months): 11
• Patients Per Site: 18
• Patients Per Site Per Month: 1.6

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Contact Lens Solution Toxicity	Other: RevitaLens; Other: OptiFree PureMoist	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 54 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: Single (Investigator)
• Primary Purpose: Supportive Care
• Official Title: Assessing Patient Comfort in Silicone Hydrogel Contact Lenses When Cleaned and Stored in Two Different Multi-Purpose Disinfecting Solutions
• Study Start Date: Jun 1, 2013
• Anticipated Primary Completion Date: Dec 1, 2013
• Anticipated Study Completion Date: May 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: RevitaLens AMO's RevitaLens contact lens solution	Other: RevitaLens; Multi-purpose disinfecting solution; Other Names: AMO's RevitaLens ; Other: OptiFree PureMoist; Multi-purpose disinfecting solution; Other Names: Alcon's OptiFree PureMoist MPS

Outcome Measures

Primary Outcome Measures

1. Self-reported comfort scores with contact lens care systems [14 days]

   Comfort measured by questionnaires covering positive and negative attributes of contact lens wear

Eligibility Criteria

Criteria

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

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Milton M. Hom, OD, FAAO	Azusa	California	United States	91702
2	Kirk L. Smick, OD, FAAO.	Morrow	Georgia	United States	30260
3	Ian Ben Gaddie, OD, FAAO.	Louisville	Kentucky	United States	40222

Sponsors and Collaborators

• Hom, Milton M., OD, FAAO
• Abbott Medical Optics

Investigators

• Principal Investigator: Milton M Hom, OD FAAO,

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Milton M. Hom, OD, FAAO., Optometrist, Hom, Milton M., OD, FAAO
• ClinicalTrials.gov Identifier: NCT01847105
• Other Study ID Numbers: 12-GHS Comfort Study
• First Posted: May 6, 2013
• Last Update Posted: May 29, 2013
• Last Verified: May 1, 2013

Study Results

No Results Posted as of May 29, 2013