Contact Lens Related Dry Eye
Conditions
Keywords
contact lens wear, multi-purpose solution, corneal staining
Brief summary
The purpose of this study was to clinically evaluate the potential causes of contact lens-related dry eye.
Detailed description
Daily wear soft contact lens wearers reporting significant contact lens-related dryness symptoms were enrolled. Late day dryness with contact lenses, intensity grade 3-5, frequency sometimes / frequently / constantly as evaluated by a questionnaire was considered significant.
Interventions
DEVICEOpti-Free RepleniSH
Contact lens care solution containing polyquaternium-1 (PQT)
DEVICEReNu MultiPlus
Contact lens care solution containing polyhexamethylene biguanide (PHMB)
DEVICEContact lenses
Daily wear, frequent replacement contact lenses per participant's habitual brand and power.
Sponsors
Alcon Research
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Reports late-day dryness symptoms with contact lens wear on questionnaire. * Wears FDA Group 2 hydrogel, FDA Group 4 hydrogel, or silicone hydrogel lenses. * Consistently uses either polyhexamethylene biguanide (PHMB) or polyquaternium-1 (PQT) contact lens care products (i.e. \>6 months including 1 month immediately before enrollment). * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Wears daily disposable contact lenses. * Has significant symptoms related to lens fit or lens deposits. * Requires concurrent ocular medication (rewetting drops allowed). * Has used Restasis® in the last 3 months. * Wears punctal plugs fitted in the last 30 days. * Has any current systemic or ocular abnormality, infection or disease. * Uses any current systemic medication likely to affect tear film, e.g. antihistamines, betaadrenergic blockers, steroids. * Has a history of refractive surgery. * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Subjective Dryness | 2 weeks, one month |
Secondary
| Measure | Time frame |
|---|---|
| corneal staining | 2 weeks, one month |
| conjunctival staining | two weeks, one month |
Countries
United States
Outcome results
None listed