Clinical Evaluation of the Causes of Contact Lens Related Dry Eye
A Clinical Evaluation of the Causes of Soft Contact Lens Related Dry Eye
1 other identifier
interventional
159
1 country
1
Brief Summary
The purpose of this study was to clinically evaluate the potential causes of contact lens-related dry eye.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2009
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 14, 2009
CompletedFirst Posted
Study publicly available on registry
October 15, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedNovember 17, 2016
March 1, 2012
8 months
October 14, 2009
November 15, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Subjective Dryness
2 weeks, one month
Secondary Outcomes (2)
corneal staining
2 weeks, one month
conjunctival staining
two weeks, one month
Study Arms (2)
OFR
EXPERIMENTALOpti-Free RepleniSH contact lens care solution used for 30 days
RNM
ACTIVE COMPARATORReNu MultiPlus contact lens care solution used for 30 days
Interventions
Daily wear, frequent replacement contact lenses per participant's habitual brand and power.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alcon Researchlead
Study Sites (1)
Contact Alcon Call Center For Trial Locations
Fort Worth, Texas, 76134, United States
Related Publications (1)
Chalmers RL, Young G, Kern J, Napier L, Hunt C. Soft Contact Lens-Related Symptoms in North America and the United Kingdom. Optom Vis Sci. 2016 Aug;93(8):836-47. doi: 10.1097/OPX.0000000000000927.
PMID: 27391535RESULT
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 14, 2009
First Posted
October 15, 2009
Study Start
August 1, 2009
Primary Completion
April 1, 2010
Study Completion
April 1, 2010
Last Updated
November 17, 2016
Record last verified: 2012-03