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

Abbott

Status and phase

Completed

Phase 2

Phase 1

Conditions

Myopia

Astigmatism

Hyperopia

Treatments

Device: RevitaLens OcuTec MPS (Investigational MPS) and Opti-Free RepleniSH MPS (control)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01024855

COBR-106-9608

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

All

Ages

18 to 99 years old

Volunteers

Accepts Healthy Volunteers

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.