A Study to Determine the Prevalence of Inflammatory Dry Eye Disease in Patients Prior to Cataract Removal
REVEAL
1 other identifier
observational
204
1 country
6
Brief Summary
This study will evaluate the prevalence of inflammatory dry eye disease in patients prior to cataract surgery. No treatment is administered in this study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2013
Shorter than P25 for all trials
6 active sites
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
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
June 18, 2013
CompletedFirst Posted
Study publicly available on registry
June 20, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2014
CompletedResults Posted
Study results publicly available
December 3, 2015
CompletedDecember 3, 2015
November 1, 2015
9 months
June 18, 2013
September 17, 2015
November 2, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Patients With a Presence of Matrix Metalloproteinase-9 (MMP-9) in the Study Eye
Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye.
Up to 60 Days Prior to Surgery
Secondary Outcomes (10)
Percentage of Participants Suspected of Having Dry Eye With Elevated MMP-9
Up to 60 days prior to cataract surgery
Percentage of Participants With Elevated MMP-9 Without Prior Diagnosis or Physician Recommended Intervention
Up to 60 days prior to cataract surgery
Percentage of Participants With Elevated MMP-9 With Dry Eye Symptoms Without Conjunctival or Corneal Staining
Up to 60 days prior to cataract surgery
Percentage of Participants With Elevated MMP-9 With Dry Eye Symptoms Without Any Signs
Up to 60 days prior to cataract surgery
Percentage of Participants With Elevated MMP-9 With at Least One Dry Eye Sign Without Dry Eye Symptoms
Up to 60 days prior to cataract surgery
- +5 more secondary outcomes
Study Arms (1)
Patients with Planned Cataract Removal
Patients with planned cataract removal surgery are evaluated for the presence of inflammatory dry eye disease. No treatment is administered.
Interventions
Eligibility Criteria
Patients with planned cataract removal surgery
You may qualify if:
- Scheduled to undergo cataract removal surgery
You may not qualify if:
- Current use of eye drops or oral medications for allergic conjunctivitis
- Serious ocular injury, intraocular surgery, or refractive surgery within 6 months in the study eye
- Use of a contact lens within 4 weeks
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (6)
Unknown Facility
Brandon, Manitoba, Canada
Unknown Facility
Halifax, Nova Scotia, Canada
Unknown Facility
Barrie, Ontario, Canada
Unknown Facility
Ottawa, Ontario, Canada
Unknown Facility
Toronto, Ontario, Canada
Unknown Facility
Boisbriand, Quebec, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Vice President Medical Affairs,
- Organization
- Allergan, Inc
Study Officials
- STUDY DIRECTOR
Medical Director
Allergan
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 18, 2013
First Posted
June 20, 2013
Study Start
June 1, 2013
Primary Completion
March 1, 2014
Study Completion
March 1, 2014
Last Updated
December 3, 2015
Results First Posted
December 3, 2015
Record last verified: 2015-11