Dry Eye Syndromes
Conditions
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.
Interventions
OTHERNo intervention
No intervention
Sponsors
Allergan
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With a Presence of Matrix Metalloproteinase-9 (MMP-9) in the Study Eye | Up to 60 Days Prior to Surgery | Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Suspected of Having Dry Eye With Elevated MMP-9 | Up to 60 days prior to cataract surgery | 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 | Up to 60 days prior to cataract surgery | 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 | Up to 60 days prior to cataract surgery | 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 | Up to 60 days prior to cataract surgery | 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 | Up to 60 days prior to cataract surgery | 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 | Up to 60 days prior to cataract surgery | 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 | Up to 60 Days Prior to Surgery | 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 | Up to 60 Days Prior to Surgery | 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 | Up to 60 Days Prior to Surgery | 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 | Up to 60 Days Prior to Surgery | 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). |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 204 |
| Total | 204 |
Baseline characteristics
| Characteristic | Patients With Planned Cataract Removal |
|---|---|
| Age, Continuous | 71.8 years STANDARD_DEVIATION 7.41 |
| Sex: Female, Male Female | 121 Participants |
| Sex: Female, Male Male | 83 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 204 |
| serious Total, serious adverse events | 0 / 204 |
Outcome results
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.
Time frame: Up to 60 Days Prior to Surgery
Population: Per-protocol population included all enrolled participants who completed all the study assessments without major protocol violations.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients With Planned Cataract Removal | Percentage of Patients With a Presence of Matrix Metalloproteinase-9 (MMP-9) in the Study Eye | 36.2 percentage of participants |
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.
Time frame: Up to 60 days prior to cataract surgery
Population: Participants from the Per-protocol population, all enrolled participants who completed all the study assessments without major protocol violations, with elevated data MMP-9 and data available for analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients With Planned Cataract Removal | Percentage of Participants Suspected of Having Dry Eye With Elevated MMP-9 | 23.1 percentage of participants |
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).
Time frame: Up to 60 Days Prior to Surgery
Population: Participants from the Per-protocol population, all enrolled participants who completed all the study assessments without major protocol violations, with elevated MMP-9 and data available for analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patients With Planned Cataract Removal | Percentage of Participants With Elevated MMP-9 and an Ocular Surface Disease Index® (OSDI®) > 12, > 22 and ≥ 32 | OSDI > 12 (n=116) | 39.7 percentage of participants |
| Patients With Planned Cataract Removal | Percentage of Participants With Elevated MMP-9 and an Ocular Surface Disease Index® (OSDI®) > 12, > 22 and ≥ 32 | OSDI > 22 (n=76) | 46.1 percentage of participants |
| Patients With Planned Cataract Removal | Percentage of Participants With Elevated MMP-9 and an Ocular Surface Disease Index® (OSDI®) > 12, > 22 and ≥ 32 | OSDI > 32 (n=50) | 46.0 percentage of participants |
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.
Time frame: Up to 60 Days Prior to Surgery
Population: Participants from the Per-protocol population, all enrolled participants who completed all the study assessments without major protocol violations, with elevated MMP-9 and data available for analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients With Planned Cataract Removal | Percentage of Participants With Elevated MMP-9 Who Routinely Use Artificial Tears | 34.7 percentage of participants |
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.
Time frame: Up to 60 days prior to cataract surgery
Population: Participants from the Per-protocol population, all enrolled participants who completed all the study assessments without major protocol violations, with elevated MMP-9 and data available for analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients With Planned Cataract Removal | Percentage of Participants With Elevated MMP-9 With at Least One Dry Eye Sign and Dry Eye Symptoms | 29.3 percentage of participants |
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.
Time frame: Up to 60 days prior to cataract surgery
Population: Participants from the Per-protocol population, all enrolled participants who completed all the study assessments without major protocol violations, with elevated MMP-9 and data available for analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients With Planned Cataract Removal | Percentage of Participants With Elevated MMP-9 With at Least One Dry Eye Sign Without Dry Eye Symptoms | 38.2 percentage of participants |
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.
Time frame: Up to 60 Days Prior to Surgery
Population: Participants from the Per-protocol population, all enrolled participants who completed all the study assessments without major protocol violations, with elevated MMP-9 and data available for analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patients With Planned Cataract Removal | Percentage of Participants With Elevated MMP-9 With Corneal Staining Grade ≥ 1 and ≥ 2 | Grade ≥ 1 | 37.1 percentage of participants |
| Patients With Planned Cataract Removal | Percentage of Participants With Elevated MMP-9 With Corneal Staining Grade ≥ 1 and ≥ 2 | Grade ≥ 2 (n=43) | 41.9 percentage of participants |
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.
Time frame: Up to 60 days prior to cataract surgery
Population: Participants from the Per-protocol population, all enrolled participants who completed all the study assessments without major protocol violations, with elevated MMP-9 and data available for analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients With Planned Cataract Removal | Percentage of Participants With Elevated MMP-9 With Dry Eye Symptoms Without Any Signs | 33.3 percentage of participants |
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.
Time frame: Up to 60 days prior to cataract surgery
Population: Participants from the Per-protocol population, all enrolled participants who completed all the study assessments without major protocol violations, with elevated MMP-9 and data available for analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients With Planned Cataract Removal | Percentage of Participants With Elevated MMP-9 With Dry Eye Symptoms Without Conjunctival or Corneal Staining | 12.5 percentage of participants |
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.
Time frame: Up to 60 days prior to cataract surgery
Population: Participants from the Per-protocol population, all enrolled participants who completed all the study assessments without major protocol violations, with elevated MMP-9 and data available for analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients With Planned Cataract Removal | Percentage of Participants With Elevated MMP-9 Without Prior Diagnosis or Physician Recommended Intervention | 36.6 percentage of participants |
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.
Time frame: Up to 60 Days Prior to Surgery
Population: Participants from the Per-protocol population, all enrolled participants who completed all the study assessments without major protocol violations, with elevated MMP-9 and data available for analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients With Planned Cataract Removal | Percentage of Participants With Elevated MMP-9 With Punctal Plugs | 0 percentage of participants |