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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: November 2, 2015
Last verified: November 2015
  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 ]
    Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye.


Secondary Outcome Measures:
  • Percentage of Participants Suspected of Having Dry Eye With Elevated MMP-9 [ Time Frame: Up to 60 days prior to cataract surgery ] [ Designated as safety issue: No ]
    Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye. Suspected of having dry eye was defined as a response of "Yes" to the Investigator Dry Eye History question.

  • Percentage of Participants With Elevated MMP-9 Without Prior Diagnosis or Physician Recommended Intervention [ Time Frame: Up to 60 days prior to cataract surgery ] [ Designated as safety issue: No ]
    Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye. Participants without a prior diagnosis of keratoconjunctivitis sicca, dry eye or tear film insufficiency or physician recommended use of topical cyclosporine, artificial tears or punctal plugs are included in the analysis.

  • Percentage of Participants With Elevated MMP-9 With Dry Eye Symptoms Without Conjunctival or Corneal Staining [ Time Frame: Up to 60 days prior to cataract surgery ] [ Designated as safety issue: No ]
    Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye. Dry eye symptoms were measured by a score of at least ≥ 2 using the Subject Evaluation of Symptoms of Dryness (SESoD) questionnaire without conjunctival or corneal staining. The SESoD assesses dry eye using a 5-point scale where 0= no dryness to 4= severe dryness. Conjunctival and Corneal Staining were evaluated as part of the slit lamp biomicroscopy examination. Eye structures and surfaces were assessed for dry eye signs using a 5-point scale where: 0=none, 0.5=trace, 1=mild, 2=moderate and 3=severe. Higher values represent a worse outcome.

  • Percentage of Participants With Elevated MMP-9 With Dry Eye Symptoms Without Any Signs [ Time Frame: Up to 60 days prior to cataract surgery ] [ Designated as safety issue: No ]
    Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye. Dry eye symptoms were measured by a score of at least ≥ 2 using the SESoD questionnaire without any signs. The SESoD assesses dry eye using a 5-point scale where 0= no dryness to 4= severe dryness. Signs included conjunctival or corneal staining, Schirmer's score ≤ 7mm, or Tear Film Break-up Time [TFBUT] ≤ 10 seconds.

  • Percentage of Participants With Elevated MMP-9 With at Least One Dry Eye Sign Without Dry Eye Symptoms [ Time Frame: Up to 60 days prior to cataract surgery ] [ Designated as safety issue: No ]
    Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye. Dry Eye Signs included conjunctival or corneal staining, Schirmer's score ≤ 7 mm, or Tear Film Break-up Time [TFBUT] ≤ 10 seconds without Dry eye symptoms measured by a score of at least ≤ 1 using the SESoD questionnaire. The SESoD assessed dry eye using a 5-point scale where 0= no dryness to 4= severe dryness.

  • Percentage of Participants With Elevated MMP-9 With at Least One Dry Eye Sign and Dry Eye Symptoms [ Time Frame: Up to 60 days prior to cataract surgery ] [ Designated as safety issue: No ]
    Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye. Dry Eye Signs included conjunctival or corneal staining, Schirmer's score ≤ 7mm, or Tear Film Break-up Time [TFBUT] ≤ 10 seconds with Dry eye symptoms measured by a score of at least ≥ 2 using the SESoD questionnaire. The SESoD assessed dry eye using a 5-point scale where 0= no dryness to 4= severe dryness.

  • Percentage of Participants With Elevated MMP-9 Who Routinely Use Artificial Tears [ Time Frame: Up to 60 Days Prior to Surgery ] [ Designated as safety issue: No ]
    Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye. Artificial Tear usage was assessed by the investigator.

  • Percentage of Participants With Elevated MMP-9 With Punctal Plugs [ Time Frame: Up to 60 Days Prior to Surgery ] [ Designated as safety issue: No ]
    Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye. A history of punctual plug usage was assessed by the investigator.

  • Percentage of Participants With Elevated MMP-9 With Corneal Staining Grade ≥ 1 and ≥ 2 [ Time Frame: Up to 60 Days Prior to Surgery ] [ Designated as safety issue: No ]
    Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye. Corneal Staining was evaluated as part of the slit lamp biomicroscopy examination. Eye structures and surfaces were assessed for signs of dry eye using a 5-point scale where: 0=none, 0.5=trace, 1=mild, 2=moderate and 3=severe. Higher values represent a worse outcome.

  • Percentage of Participants With Elevated MMP-9 and an Ocular Surface Disease Index® (OSDI®) > 12, > 22 and ≥ 32 [ Time Frame: Up to 60 Days Prior to Surgery ] [ Designated as safety issue: No ]
    Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye. The OSDI consists of 12 questions to assess visual function, ocular symptoms and environmental triggers related to dry eye. Each of the 12 questions is assessed using a 5-point scale (0=none of the time to 4=all of the time) which is converted to a total score between 0-100. OSDI total scores of 0-12=normal (best), 13-22= mild ocular surface disease, 23-32 =moderate ocular surface disease, and 33-100=severe ocular surface disease (worst).


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   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01882413

Locations
Canada, Manitoba
Brandon, Manitoba, Canada
Canada, Nova Scotia
Halifax, Nova Scotia, Canada
Canada, Ontario
Barrie, Ontario, Canada
Ottawa, Ontario, Canada
Toronto, Ontario, Canada
Canada, Quebec
Boisbriand, Quebec, Canada
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01882413     History of Changes
Other Study ID Numbers: GMA-RES-012-001 
Study First Received: June 18, 2013
Results First Received: September 17, 2015
Last Updated: November 2, 2015
Health Authority: Canada: Ethics Review Committee

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

ClinicalTrials.gov processed this record on September 29, 2016