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Testing the Safety and Acceptability of Using a Rewetting Drop with Contact Lenses
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Carboxymethylcellulose sodium and Glycerin | Experimental | Carboxymethylcellulose sodium and Glycerin based rewetting drop |
|
| Carboxymethylcellulose sodium | Active Comparator | Carboxymethylcellulose sodium based rewetting drop |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carboxymethylcellulose sodium and Glycerin | Device | Eye drops used at least 4 times per day, 1-2 drops in each eye while wearing contact lenses. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Best Corrected Visual Acuity | Percentage of Subjects Tabulated by Changes in Line Number at Day 90 from Baseline; Visual Acuity measured by LogMar reported as Snellen equivalents. Better: an increase of 2 lines or more in at least one eye; No Change: a change less than +/- 2 lines in both eyes; Worse: a decrease of 2 lines or more in at least one eye. | Change from Baseline at Day 90 |
| Measure | Description | Time Frame |
|---|---|---|
| Corneal Staining | Corneal staining of greater or equal to grade 2 at day 90. Grading scale: 0 = None Present; 1 = Trace Finding; 2 = Mild Finding; 3 = Moderate Finding; 4 = Severe Finding | Day 90 |
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Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Diego | California | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Carboxymethylcellulose Sodium and Glycerin | Carboxymethylcellulose sodium and Glycerin based rewetting drop |
| FG001 | Carboxymethylcellulose Sodium | Carboxymethylcellulose sodium based rewetting drop |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Carboxymethylcellulose Sodium and Glycerin | Carboxymethylcellulose sodium and Glycerin based rewetting drop |
| BG001 | Carboxymethylcellulose Sodium | Carboxymethylcellulose sodium based rewetting drop |
| 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 | Best Corrected Visual Acuity | Percentage of Subjects Tabulated by Changes in Line Number at Day 90 from Baseline; Visual Acuity measured by LogMar reported as Snellen equivalents. Better: an increase of 2 lines or more in at least one eye; No Change: a change less than +/- 2 lines in both eyes; Worse: a decrease of 2 lines or more in at least one eye. | Completed Population | Posted | Number | Percentage of Participants | Change from Baseline at Day 90 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Carboxymethylcellulose Sodium and Glycerin | Carboxymethylcellulose sodium and Glycerin based rewetting drop |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthenopia | Eye disorders | MedDRA (11.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | Allergan, Inc. | (714)246-4500 | clinicaltrials@allergan.com |
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| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| Carboxymethylcellulose sodium | Device | Eye drops used at least 4 times per day, 1-2 drops in each eye while wearing contact lenses. |
|
|
| BG002 | Total | Total of all reporting groups |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Post-Hoc | Patient Acceptability | A questionnaire was administered to all patients to evaluate the acceptability of the Rewetting Drops (RD) with use with Contact Lenses (CL). Table below shows the percentage of participants responding either "Agree" or "Strongly Agree" at day 90. Number of participants answering question is indicated as (number of Test subjects/number of Control subjects) | Intent to Treat Population | Posted | Number | Percentage of Participants | Day 90 |
|
|
|
| Secondary | Corneal Staining | Corneal staining of greater or equal to grade 2 at day 90. Grading scale: 0 = None Present; 1 = Trace Finding; 2 = Mild Finding; 3 = Moderate Finding; 4 = Severe Finding | Completed Population | Posted | Number | Participants | Day 90 |
|
|
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| Post-Hoc | Patient Preference | Percentage of patients who used pre-study rewetting drops and answered "Agree" or "Strongly Agree" when asked if they preferred the study drops (SD) over their pre-study drops(PSD). | Responders Completed Population | Posted | Number | Percentage of participants | Day 30 |
|
|
|
| 0 |
| 166 |
| 15 |
| 166 |
| EG001 | Carboxymethylcellulose Sodium | Carboxymethylcellulose sodium based rewetting drop | 0 | 79 | 11 | 79 |
| Dry eye | Eye disorders | MedDRA (11.0) | Systematic Assessment |
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| Eye discharge | Eye disorders | MedDRA (11.0) | Systematic Assessment |
|
| Eye irritation | Eye disorders | MedDRA (11.0) | Systematic Assessment |
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| Ocular discomfort | Eye disorders | MedDRA (11.0) | Systematic Assessment |
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| Conjunctival oedema | Eye disorders | MedDRA (11.0) | Systematic Assessment |
|
| Conjunctivitis allergic | Eye disorders | MedDRA (11.0) | Systematic Assessment |
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| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Systematic Assessment |
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| Episcleritis | Eye disorders | MedDRA (11.0) | Systematic Assessment |
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| Eye pruritus | Eye disorders | MedDRA (11.0) | Systematic Assessment |
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| Limbal hyperaemia | Eye disorders | MedDRA (11.0) | Systematic Assessment |
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| Ocular hyperaemia | Eye disorders | MedDRA (11.0) | Systematic Assessment |
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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 more than 60 days but 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.
| RD on CL gave good initial comfort (161/79) |
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| At day's end,CL felt better after RD use (161/78) |
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| Could wear CL longer when using RD (161/79) |
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| Vision was normal soon after using RD (161/79) |
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| Vision with CL was better after RD use (161/79) |
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| Would likely purchase these RD (161/79) |
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| Eyes felt better after CL removal (161/79) |
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