Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Centre for Ocular Research & Education, Canada | OTHER |
Not provided
Not provided
Not provided
The objective of the study was to adapt existing multifocal soft lens wearers to a Control Lens for at least 2 weeks and then evaluate the success of switching them to the Test Lens, with a review after 2 weeks.
This prospective, bilateral eye, open label, non-randomized study compared the performance of 2 different designs of daily disposable multifocal contact lenses.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Lens | Active Comparator | All participants wore the Control Lens for 2 weeks (Period 1) |
|
| Test Lens | Experimental | All participants wore the Test Lens for 2 weeks (Period 2) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control Lens | Device | Daily disposable multifocal soft lens with 2 add design (2ADD) for 2 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comfort Just After Lens Insertion | Subjective rating measured on a scale of 0-10, 0.5 steps, where 0=Painful, 10=Can't feel the lenses. | 2 weeks |
Not provided
Not provided
Inclusion Criteria:
A person was eligible for inclusion in the study if he/she:
Exclusion Criteria:
A person was excluded from the study if he/she:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Andrew Sacco | Sacco Eye Group | Principal Investigator |
| Shane Kannarr | Kannarr Eye Care | Principal Investigator |
| Katherine Bickle | ProCare Vision Center | Principal Investigator |
| Michael Cymbor | Nittany Eye Associates | Principal Investigator |
| Roxanne Achong-Coan | Coan Eye Care & Optical Boutique | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Coan Eye Care & Optical Boutique | Ocoee | Florida | 34761 | United States | ||
| Kannarr Eye Care |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Control Lens (2ADD) | All participants wore the Control Lens for 2 weeks (Period 1) |
| FG001 | Test Lens (3ADD) | All participants wore the Test Lens for 2 weeks (Period 2) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1: Control Lens, 2 Weeks |
| |||||||||||||
| Period 2: Test Lens, 2 Weeks |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | Includes all study participants |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Comfort Just After Lens Insertion | Subjective rating measured on a scale of 0-10, 0.5 steps, where 0=Painful, 10=Can't feel the lenses. | All participants wore Control Lens and Test Lens in sequential order. | Posted | Mean | Standard Deviation | score on a scale | 2 weeks |
|
From dispense to study exit, approximately 6-8 weeks.
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 | Control Lens (2ADD) | Participants that received Control Lens | 0 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Influenza | Infections and infestations | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| José A. Vega OD, MSc, FAAO, PhD | CooperVision Inc. | 19256213761 | javega@coopervision.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 8, 2022 | Jan 23, 2024 | Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D011305 | Presbyopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Test Lens | Device | Daily disposable multifocal soft lens with 3 add design (3ADD) for 2 weeks |
|
| Pittsburg |
| Kansas |
| 66762 |
| United States |
| Sacco Eye Group | Vestal | New York | 13850 | United States |
| ProCare Vision Center | Granville | Ohio | 43023 | United States |
| Nittany Eye Associates | State College | Pennsylvania | 16801 | United States |
| NOT COMPLETED |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| 60 |
| 0 |
| 60 |
| 1 |
| 60 |
| EG001 | Test Lens (3ADD) | Participants that received Test Lens | 0 | 60 | 0 | 60 | 0 | 60 |
Not provided
Not provided