Trial Outcomes & Findings for A Study to Determine the Prevalence of Inflammatory Dry Eye Disease in Patients Prior to Cataract Removal (NCT NCT01882413)

NCT ID: NCT01882413

Last Updated: 2015-12-03

Results Overview

Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye.

Recruitment status

COMPLETED

Target enrollment

204 participants

Primary outcome timeframe

Up to 60 Days Prior to Surgery

Results posted on

2015-12-03

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	204
Overall Study COMPLETED	204
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patients With Planned Cataract Removal n=204 Participants Patients with planned cataract removal surgery are evaluated for the presence of inflammatory dry eye disease. No treatment is administered.
Age, Continuous	71.8 years STANDARD_DEVIATION 7.41 • n=5 Participants
Sex: Female, Male Female	121 Participants n=5 Participants
Sex: Female, Male Male	83 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye.

Outcome measures

Outcome measures
Measure	Patients With Planned Cataract Removal n=199 Participants Patients with planned cataract removal surgery are evaluated for the presence of inflammatory dry eye disease. No treatment is administered.
Percentage of Patients With a Presence of Matrix Metalloproteinase-9 (MMP-9) in the Study Eye	36.2 percentage of participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Patients With Planned Cataract Removal n=39 Participants Patients with planned cataract removal surgery are evaluated for the presence of inflammatory dry eye disease. No treatment is administered.
Percentage of Participants Suspected of Having Dry Eye With Elevated MMP-9	23.1 percentage of participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Patients With Planned Cataract Removal n=142 Participants Patients with planned cataract removal surgery are evaluated for the presence of inflammatory dry eye disease. No treatment is administered.
Percentage of Participants With Elevated MMP-9 Without Prior Diagnosis or Physician Recommended Intervention	36.6 percentage of participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Patients With Planned Cataract Removal n=16 Participants Patients with planned cataract removal surgery are evaluated for the presence of inflammatory dry eye disease. No treatment is administered.
Percentage of Participants With Elevated MMP-9 With Dry Eye Symptoms Without Conjunctival or Corneal Staining	12.5 percentage of participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Patients With Planned Cataract Removal n=3 Participants Patients with planned cataract removal surgery are evaluated for the presence of inflammatory dry eye disease. No treatment is administered.
Percentage of Participants With Elevated MMP-9 With Dry Eye Symptoms Without Any Signs	33.3 percentage of participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Patients With Planned Cataract Removal n=131 Participants Patients with planned cataract removal surgery are evaluated for the presence of inflammatory dry eye disease. No treatment is administered.
Percentage of Participants With Elevated MMP-9 With at Least One Dry Eye Sign Without Dry Eye Symptoms	38.2 percentage of participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Patients With Planned Cataract Removal n=58 Participants Patients with planned cataract removal surgery are evaluated for the presence of inflammatory dry eye disease. No treatment is administered.
Percentage of Participants With Elevated MMP-9 With at Least One Dry Eye Sign and Dry Eye Symptoms	29.3 percentage of participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Patients With Planned Cataract Removal n=49 Participants Patients with planned cataract removal surgery are evaluated for the presence of inflammatory dry eye disease. No treatment is administered.
Percentage of Participants With Elevated MMP-9 Who Routinely Use Artificial Tears	34.7 percentage of participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Patients With Planned Cataract Removal n=1 Participants Patients with planned cataract removal surgery are evaluated for the presence of inflammatory dry eye disease. No treatment is administered.
Percentage of Participants With Elevated MMP-9 With Punctal Plugs	0 percentage of participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Patients With Planned Cataract Removal n=105 Participants Patients with planned cataract removal surgery are evaluated for the presence of inflammatory dry eye disease. No treatment is administered.
Percentage of Participants With Elevated MMP-9 With Corneal Staining Grade ≥ 1 and ≥ 2 Grade ≥ 1	37.1 percentage of participants
Percentage of Participants With Elevated MMP-9 With Corneal Staining Grade ≥ 1 and ≥ 2 Grade ≥ 2 (n=43)	41.9 percentage of participants

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Patients With Planned Cataract Removal n=199 Participants Patients with planned cataract removal surgery are evaluated for the presence of inflammatory dry eye disease. No treatment is administered.
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
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
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

Adverse Events

Patients With Planned Cataract Removal

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Vice President Medical Affairs,

Allergan, Inc

Phone: 714-246-4500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Publication restrictions are in place

Restriction type: OTHER