Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Parasol Punctal Occluder Group | Randomized to receive Brand A punctal plugs |
| |
| Superflex Punctal Occluder Group | Randomized to receive Group B punctal plugs |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Parasol Punctal Occluder | Device | Patients will be randomized to receive one of these 2 punctal occluders in the management of dry eyes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Length of Retention | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| National Eye Institute Corneal Fluorescein Staining Pattern |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Patients will be recruited from cornea and general ophthalmology specialist practices at Hotel Dieu Hospital, Queens University
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ashley R Brissette, BSc, MD | Queens University | Study Director |
| Stephanie Baxter, MD, FRCSC | Queens University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Ophthalmology, Hotel Dieu Hospital | Kingston | Ontario | K7L 5G2 | Canada |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Parasol Group | Randomized to receive Brand A punctal plugs Parasol Punctal Occluder |
| FG001 | Superflex Group | Randomized to receive Group B punctal plugs Superflex Punctal Occluder |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Parasol Group | Randomized to receive Brand A punctal plugs Parasol Punctal Occluder |
| BG001 | Superflex Group | Randomized to receive Group B punctal plugs Superflex Punctal Occluder |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Length of Retention | Posted | Mean | Standard Deviation | months | 6 months |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Parasol Group | Randomized to receive Brand A punctal plugs Parasol Punctal Occluder |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Stephanie Baxter | Queen's University | 613 544 3310 | baxters@baxtereyemd.com |
Not provided
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| Superflex Punctal Occluder | Device | Patients will be randomized to receive one of these 2 punctal occluders in the management of dry eyes. |
|
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. |
| 6 months |
| 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. | 6 months |
| Tear Meniscus Height | Meniscus height measured in mm | 6 months |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| 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. | Posted | Mean | Standard Deviation | scores on a scale | 6 months |
|
|
|
| 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. | Posted | Mean | Standard Deviation | Scores on a scale | 6 months |
|
|
|
| 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. | Posted | Mean | Standard Deviation | Scores on a scale | 6 months |
|
|
|
| Secondary | Tear Meniscus Height | Meniscus height measured in mm | Posted | Mean | Standard Deviation | mm | 6 months |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | Superflex Group | Randomized to receive Group B punctal plugs Superflex Punctal Occluder | 0 | 25 | 0 | 25 |
Not provided
Not provided