Dry Eye
Conditions
Brief summary
The purpose of this study is to determine if Parasol punctal occluders (Brand A) have a higher rate of retention than Superflex punctal plugs (Brand B).
Detailed description
Eyes will be randomized to either Brand A or Brand B punctal plug. The primary outcome measure is length of time punctual plugs are retained, measured in months. This will be measured at monthly assessments for 6 months. Secondary outcome measures include patient satisfaction, and improvement in subjective and objective dry eye scores, as well as complications related to punctual plugs including spontaneous plug loss, and intolerance. We will evaluate these measures by repeating the Canadian Dry Eye Assessment, Schirmer 1, tear meniscus height, fluorescein corneal staining (NEI scale), and lissamine green conjunctival staining (NEI scale) at month 1, month 3, and month 6 visits.
Interventions
DEVICEParasol Punctal Occluder
Patients will be randomized to receive one of these 2 punctal occluders in the management of dry eyes.
DEVICESuperflex Punctal Occluder
Patients will be randomized to receive one of these 2 punctal occluders in the management of dry eyes.
Sponsors
Queen's University
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* moderate dry eye, severe dry eye
Exclusion criteria
* silicone allergy, punctal stenosis, punctal occlusion, punctal cautery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Length of Retention | 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Canadian Dry Eye Assessment Score | 6 months | Describes the scores on a scale and range from 0-3. Higher score represents more severe dry eye. Score 0 = no dry eye symptoms, score 1 = mild dry eye symptoms, score 2 = moderate dry eye symptoms, score 3 = severe dry eye symptoms. |
| National Eye Institute Corneal Fluorescein Staining Pattern | 6 months | The cornea is divided into 5 zones, and the inferior zone 5 was assessed for staining pattern. Grade 0= no staining, grade 1= trace staining, grade 2= mild staining, grade 3= moderate staining, and grade 4= severe staining. |
| National Eye Institute Grading for Conjunctival Staining | 6 months | The conjunctival staining is divided into 6 zones. Each zone received a score for staining with lissamine green. Grade 0= no staining, grade 1= trace staining, grade 2= mild staining, grade 3= moderate staining, grade 4= severe staining. Data from different zones was combined and the total value was averaged. |
| Tear Meniscus Height | 6 months | Meniscus height measured in mm |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Parasol Group Randomized to receive Brand A punctal plugs
Parasol Punctal Occluder | 25 |
| Superflex Group Randomized to receive Group B punctal plugs
Superflex Punctal Occluder | 25 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Superflex Group | Parasol Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 6 Participants | 11 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 19 Participants | 39 Participants |
| Age, Continuous | 58.4 years STANDARD_DEVIATION 16.18 | 61.7 years STANDARD_DEVIATION 17.67 | 60.1 years STANDARD_DEVIATION 15.97 |
| Region of Enrollment Canada | 25 participants | 25 participants | 50 participants |
| Sex: Female, Male Female | 23 Participants | 22 Participants | 45 Participants |
| Sex: Female, Male Male | 2 Participants | 3 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 25 | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 |
Outcome results
Primary
Length of Retention
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Parasol Group | Length of Retention | 6 months | Standard Deviation 0 |
| Superflex Group | Length of Retention | 6 months | Standard Deviation 0 |
Secondary
Canadian Dry Eye Assessment Score
Describes the scores on a scale and range from 0-3. Higher score represents more severe dry eye. Score 0 = no dry eye symptoms, score 1 = mild dry eye symptoms, score 2 = moderate dry eye symptoms, score 3 = severe dry eye symptoms.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Parasol Group | Canadian Dry Eye Assessment Score | 1.06 scores on a scale | Standard Deviation 1.081 |
| Superflex Group | Canadian Dry Eye Assessment Score | 0.25 scores on a scale | Standard Deviation 1.018 |
Secondary
National Eye Institute Corneal Fluorescein Staining Pattern
The cornea is divided into 5 zones, and the inferior zone 5 was assessed for staining pattern. Grade 0= no staining, grade 1= trace staining, grade 2= mild staining, grade 3= moderate staining, and grade 4= severe staining.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Parasol Group | National Eye Institute Corneal Fluorescein Staining Pattern | 3.28 Scores on a scale | Standard Deviation 1.091 |
| Superflex Group | National Eye Institute Corneal Fluorescein Staining Pattern | 3.60 Scores on a scale | Standard Deviation 0.756 |
Secondary
National Eye Institute Grading for Conjunctival Staining
The conjunctival staining is divided into 6 zones. Each zone received a score for staining with lissamine green. Grade 0= no staining, grade 1= trace staining, grade 2= mild staining, grade 3= moderate staining, grade 4= severe staining. Data from different zones was combined and the total value was averaged.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Parasol Group | National Eye Institute Grading for Conjunctival Staining | 2.08 Scores on a scale | Standard Deviation 0.895 |
| Superflex Group | National Eye Institute Grading for Conjunctival Staining | 2.08 Scores on a scale | Standard Deviation 0.463 |
Secondary
Tear Meniscus Height
Meniscus height measured in mm
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Parasol Group | Tear Meniscus Height | 0.472 mm | Standard Deviation 0.398 |
| Superflex Group | Tear Meniscus Height | 0.468 mm | Standard Deviation 0.217 |