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

Dry Eye Syndromes Clinical Trial

— REVEAL  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01882413
• Other study ID #: GMA-RES-012-001
• Status: Completed
• Phase: N/A
• First received: June 18, 2013
• Last updated: November 2, 2015
• Start date: June 2013
• Est. completion date: March 2014

Study information

• Verified date: November 2015
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 204
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Percentage of Participants Suspected of Having Dry Eye With Elevated MMP-9	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.	Up to 60 days prior to cataract surgery	No
Secondary	Percentage of Participants With Elevated MMP-9 Without Prior Diagnosis or Physician Recommended Intervention	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.	Up to 60 days prior to cataract surgery	No
Secondary	Percentage of Participants With Elevated MMP-9 With Dry Eye Symptoms Without Conjunctival or Corneal Staining	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.	Up to 60 days prior to cataract surgery	No
Secondary	Percentage of Participants With Elevated MMP-9 With Dry Eye Symptoms Without Any Signs	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.	Up to 60 days prior to cataract surgery	No
Secondary	Percentage of Participants With Elevated MMP-9 With at Least One Dry Eye Sign Without Dry Eye Symptoms	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.	Up to 60 days prior to cataract surgery	No
Secondary	Percentage of Participants With Elevated MMP-9 With at Least One Dry Eye Sign and Dry Eye Symptoms	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.	Up to 60 days prior to cataract surgery	No
Secondary	Percentage of Participants With Elevated MMP-9 Who Routinely Use Artificial Tears	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.	Up to 60 Days Prior to Surgery	No
Secondary	Percentage of Participants With Elevated MMP-9 With Punctal Plugs	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.	Up to 60 Days Prior to Surgery	No
Secondary	Percentage of Participants With Elevated MMP-9 With Corneal Staining Grade = 1 and = 2	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.	Up to 60 Days Prior to Surgery	No
Secondary	Percentage of Participants With Elevated MMP-9 and an Ocular Surface Disease Index® (OSDI®) > 12, > 22 and = 32	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).	Up to 60 Days Prior to Surgery	No