A Study to Determine the Prevalence of Inflammatory Dry Eye Disease in Patients Prior to Cataract Removal (REVEAL)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01882413
First received: June 18, 2013
Last updated: April 15, 2014
Last verified: April 2014
  Purpose

This study will evaluate the prevalence of inflammatory dry eye disease in patients prior to cataract surgery. No treatment is administered in this study.


Condition Intervention
Dry Eye Syndromes
Other: No intervention

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Percentage of Patients with a Presence of Matrix Metalloproteinase-9 (MMP-9) in the Study Eye [ Time Frame: Up to 60 Days Prior to Surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Subject Evaluation of Symptoms of Dryness on a 5-Point Scale [ Time Frame: Up to 60 Days Prior to Surgery ] [ Designated as safety issue: No ]
  • Ocular Surface Disease Index© (OSDI©) Questionnaire Score [ Time Frame: Up to 60 Days Prior to Surgery ] [ Designated as safety issue: No ]
  • Tear Film Break-up Time (TFBUT) [ Time Frame: Up to 60 Days Prior to Surgery ] [ Designated as safety issue: No ]
  • Corneal Staining on a 6-Point Scale [ Time Frame: Up to 60 Days Prior to Surgery ] [ Designated as safety issue: No ]
  • Conjunctival Staining on a 6-Point Scale [ Time Frame: Up to 60 Days Prior to Surgery ] [ Designated as safety issue: No ]
  • Tear Wetting Using Schirmer's test [ Time Frame: Up to 60 Days Prior to Surgery ] [ Designated as safety issue: No ]
  • Artificial Tear Use [ Time Frame: Up to 60 Days Prior to Surgery ] [ Designated as safety issue: No ]
  • History of Punctal Plug Use [ Time Frame: Up to 60 Days Prior to Surgery ] [ Designated as safety issue: No ]

Enrollment: 204
Study Start Date: June 2013
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
Other: No intervention
No intervention

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with planned cataract removal surgery

Criteria

Inclusion Criteria:

  • Scheduled to undergo cataract removal surgery

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01882413

Locations
Canada, Ontario
Barrie, Ontario, Canada
Ottawa, Ontario, Canada
Canada, Quebec
Boisbriand, Quebec, Canada
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01882413     History of Changes
Other Study ID Numbers: GMA-RES-012-001
Study First Received: June 18, 2013
Last Updated: April 15, 2014
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Dry Eye Syndromes
Keratoconjunctivitis Sicca
Lacrimal Apparatus Diseases
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases

ClinicalTrials.gov processed this record on April 15, 2014