Comparative Evaluation of Corneal Staining With Balafilcon A Lenses and Two Multi-Purpose Solutions

Myopia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01024855
• Other study ID #: COBR-106-9608
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: December 2, 2009
• Last updated: September 30, 2015
• Start date: April 2009
• Est. completion date: June 2009

Study information

• Verified date: March 2012
• Source: Abbott Medical Optics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

A new multi-purpose solution (MPS)was clinically evaluated against Opti-Free RepleniSH MPS at specific time points over the course of four days. The study was conducted with PureVision lenses.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• were at least 18 years old;

• were experienced contact lens wearers;

• were correctable to at least 20/40 or better in both eyes with contact lenses;

• were in good general health, with healthy eyes (other than requiring vision correction);

• had not worn lenses for at least 12 hours before each baseline visit;

• had a corneal staining score no greater than Grade 1 in either eye at time of enrollment;

• had previously used an MPS or hydrogen peroxide solution successfully.

Exclusion Criteria:

• had a confirmed diagnosis of Sjögren's syndrome or other condition that results in a chronic and/or pathologic dry eye condition;

• required concurrent ocular medication or have used ocular medication within 24 hours of entering the study;

• had a known sensitivity or intolerance to any MPS, study products or ingredient(s);

• were currently participating in any other clinical study;

• had a condition or are in a situation that, in the investigator's opinion, may put them at significant risk, confound the study results, or interfere significantly with their participation in the study.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Astigmatism
• Hyperopia
• Myopia

Intervention

Device:
• RevitaLens OcuTec MPS (Investigational MPS) and Opti-Free RepleniSH MPS (control)
multi-purpose lens care solution

Locations

Country	Name	City	State
United States	Abbott Medical Optics Inc.	Santa Ana	California

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Optics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Eyes With No Change in Corneal Staining	Subjects examined after corneal staining (a method used to assess the condition of the cornea) using a slit lamp to determine change from baseline and rated based on the following scale: 0=no change from baseline, 1=trace, 2=mild, 3=moderate, 4=severe.	Change from baseline after 1, 2, 4 and 6+ hours of wear	Yes