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

NCT01240122 | Completed Results

• 1 other identifier: COBR-109-9608
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Corneal Staining

Keywords

Corneal staining and comfort evaluation in normal, habitual contact lens wearers.

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Subjective Solution Preference

  Day 4

• Overall Ocular Comfort

  Day 4

Study Arms (2)

Biotrue MPS

ACTIVE COMPARATOR

Device: Biotrue MPS

Investigational MPS

EXPERIMENTAL

Device: Investigational MPS

Interventions

Biotrue MPS DEVICE

Multi-purpose contact lens care solution

Biotrue MPS

Investigational MPS DEVICE

Multi-purpose contact lens care solution

Investigational MPS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abbott Medical Optics: lead

Study Sites (1)

Abbott Medical Optics Inc

Santa Ana, California, 92705, United States

Location

Results Point of Contact

• Title: Senior Manager, Clinical Research
• Organization: Abbott Medical Optics

eugenia.kao@amo.abbott.com

714.247.8723

Study Officials

• Eugenia Y Kao, OD

  AMO

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2010
• First Posted: November 15, 2010
• Study Start: August 31, 2010
• Primary Completion: November 30, 2010
• Study Completion: November 30, 2010
• Last Updated: March 3, 2025
• Results First Posted: June 11, 2012

Record last verified: 2025-02

Locations

US (1)