Status:
COMPLETED
Clinical Evaluation of the Causes of Contact Lens Related Dry Eye
Lead Sponsor:
Alcon Research
Conditions:
Contact Lens Related Dry Eye
Eligibility:
All Genders
18+ years
Phase:
NA
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 / freque...
Eligibility Criteria
Inclusion
- 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
- 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 exclusion criteria may apply.
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
159 Patients enrolled
Trial Details
Trial ID
NCT00995189
Start Date
August 1 2009
End Date
April 1 2010
Last Update
November 17 2016
Active Locations (1)
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1
Contact Alcon Call Center For Trial Locations
Fort Worth, Texas, United States, 76134