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

Corneal Staining Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01240122
• Other study ID #: COBR-109-9608
• Status: Completed
• Phase: N/A
• First received: November 8, 2010
• Last updated: January 10, 2018
• Start date: August 2010
• Est. completion date: November 2010

Study information

• Verified date: January 2018
• Source: Abbott Medical Optics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

An investigational multi-purpose solution (MPS)was clinically evaluated against Biotrue 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: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

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.

Related Conditions & MeSH terms

• Corneal Staining

Intervention

Device:
• Biotrue MPS
Multi-purpose contact lens care solution
• Investigational MPS
Multi-purpose contact 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	Corneal Staining by Wear Time	All participants were contact lenses wearers and were evaluated with a Corneal Staining at 1 hour, 2 hours, 4 hours and end of day. The corneal staining test is performed using fluorescein drops in the eye and ultraviolet illumination to determine if there has been any damage to the cornea from the use of the lens solutions or from the use of the contact lens.	1 hour on Day 1, 2 hours on Day 2, 4 hours on Day 3 and End of Day on Day 4
Secondary	Subjective Solution Preference	All subjects were asked which solution they prefer based on comfort level: Biotrue MPS, Investigational MPS, or no difference.	Day 4
Secondary	Overall Ocular Comfort	All subjects were asked to rate their lens comfort at each visit based on an 11 point scale where 0 meant that the lens could not be tolerated and 10 indicated that the lens could not be felt.	Day 4