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This 6 month study seeks to compare the use of Intracanalicular Dexamethasone in conjunction with Restasis (cyclosporine ophthalmic emulsion) for the treatment of signs and symptoms of dry eye disease as compared to Restasis with Lotemax (loteprednol etabonate ophthalmic suspension 0.5%) and Restasis monotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Restasis and Lotemax | Active Comparator | 10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes and Lotemax ophthalmic solution twice a day in both eyes. |
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| Restasis and Dextenza | Active Comparator | 10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes, as well as receiving Dextenza insertion in both lower lids. |
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| Restasis | Active Comparator | 10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cyclosporine | Drug | Used to increase tear production in patients who have dry eye caused by inflammation |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean Ocular Surface Staining From Baseline | The primary outcome measure was the mean corneal surface staining (guided by use of fluorescein and lissamine green) at weeks 4, 8 and 12 from baseline based on the National Eye Institute grading scale. Corneal fluorescein staining was scored from 0 to 3 on the scale (none, better to heavy, worse) in five regions of the cornea and summed for a total score of 0-15. | Baseline to Week 4, Week 8 and Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Conjunctival Staining | The mean conjunctival staining (guided by use of lissamine green) at weeks 4, 8 and 12 from baseline based on the National Eye Institute grading scale. Conjunctival staining was scored from 0 to 3 on the scale (none, better to heavy, worse) in six regions of the cornea and summed for a total score of 0-18. | Baseline to Week 4, Week 8 and Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Eye Clinic | Brecksville | Ohio | 44141 | United States |
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Thirty patients were enrolled in the study. 10 patients in each treatment group.
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| ID | Title | Description |
|---|---|---|
| FG000 | Restasis and Lotemax | 10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes and Lotemax ophthalmic solution twice a day in both eyes. Cyclosporine: Used to increase tear production in patients who have dry eye caused by inflammation Loteprednol Etabonate: Used to treat inflammation of the eye |
| FG001 | Restasis and Dextenza | 10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes, as well as receiving Dextenza insertion in both lower lids. Cyclosporine: Used to increase tear production in patients who have dry eye caused by inflammation Dexamethasone Ophthalmic 0.4 Mg Ophthalmic Insert: Used to treat inflammation of the eye |
| FG002 | Restasis | 10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes Cyclosporine: Used to increase tear production in patients who have dry eye caused by inflammation |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Restasis and Lotemax | 10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes and Lotemax ophthalmic solution twice a day in both eyes. Cyclosporine: Used to increase tear production in patients who have dry eye caused by inflammation Loteprednol Etabonate: Used to treat inflammation of the eye |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Mean Ocular Surface Staining From Baseline | The primary outcome measure was the mean corneal surface staining (guided by use of fluorescein and lissamine green) at weeks 4, 8 and 12 from baseline based on the National Eye Institute grading scale. Corneal fluorescein staining was scored from 0 to 3 on the scale (none, better to heavy, worse) in five regions of the cornea and summed for a total score of 0-15. | Posted | Mean | Standard Deviation | Score on a scale | Baseline to Week 4, Week 8 and Week 12 | Eyes | Eyes |
|
Baseline to Week 12
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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 | Restasis and Lotemax | 10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes and Lotemax ophthalmic solution twice a day in both eyes. Cyclosporine: Used to increase tear production in patients who have dry eye caused by inflammation Loteprednol Etabonate: Used to treat inflammation of the eye |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| 2+ Injection at week 8 visit. | Eye disorders | Non-systematic Assessment | 2+ injection at week 8 visit. No treatment necessary. Improving upon exit. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Thomas Chester, OD | Cleveland Eye Clinic | 440-526-1974 | tchester@midwestvision.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 11, 2021 | Jun 8, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 5, 2022 | Jun 8, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D016572 | Cyclosporine |
| D003524 | Cyclosporins |
| D000069559 | Loteprednol Etabonate |
| D002123 | Calcium Dobesilate |
| ID | Term |
|---|---|
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
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10 subjects will receive Restasis and Dextenza 10 subjects will receive Restasis and Lotemax 10 subjects will receive Restasis
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| Loteprednol Etabonate | Drug | Used to treat inflammation of the eye |
|
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| Dexamethasone Ophthalmic 0.4 Mg Ophthalmic Insert | Drug | Used to treat inflammation of the eye |
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| Mean Schirmer Tear Test 1 Score | Schirmer Tear Test 1 score, measuring tear production, as measured by a Schirmer's test strip with anesthetic (mm/5min on a strip 0-35mm. 0 mm is worse, >15 indicates normal production) at week 4, 8 and 12 from Baseline. | Baseline to Week 4, Week 8 and Week 12 |
| Tear Breakup Time (Seconds) | The time it takes (in seconds) for the tear film to break after blinking at Week 4, 8 and 12 from Baseline | Baseline to Week 4, Week 8 and Week 12 |
| Tear Osmolarity | Tear osmolarity as measured by TearLab (275-307 is considered "homeostatic range") at Week 4, 8 and 12 from Baseline. | Baseline to Week 4, Week 8 and Week 12 |
| Meibomian Gland Scores | Meibomian gland scoring on a scale of 1-4 (1 represents clear, liquid secretions and 4 is no secretions) in three regions (nasal, central, temporal) and summed for a single score between 3-12 at Week 4, 8 and 12 from baseline | Baseline to Week 4, Week 8 and Week 12 |
| DEQ-5 Score | Dry Eye Questionnaire-5 (5 questions about dry eye symptoms rated from 0, or never to 5, or constantly) total score of 0-22 with higher scores representing worse symptoms at weeks 4, 8 and 12 from baseline | Baseline to Week 4, Week 8 and Week 12 |
| Restasis and Dextenza |
10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes, as well as receiving Dextenza insertion in both lower lids. Cyclosporine: Used to increase tear production in patients who have dry eye caused by inflammation Dexamethasone Ophthalmic 0.4 Mg Ophthalmic Insert: Used to treat inflammation of the eye |
| BG002 | Restasis | 10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes Cyclosporine: Used to increase tear production in patients who have dry eye caused by inflammation |
| BG003 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 |
| Restasis and Dextenza |
10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes, as well as receiving Dextenza insertion in both lower lids. Cyclosporine: Used to increase tear production in patients who have dry eye caused by inflammation Dexamethasone Ophthalmic 0.4 Mg Ophthalmic Insert: Used to treat inflammation of the eye |
| OG002 | Restasis | 10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes Cyclosporine: Used to increase tear production in patients who have dry eye caused by inflammation |
|
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| Secondary | Mean Conjunctival Staining | The mean conjunctival staining (guided by use of lissamine green) at weeks 4, 8 and 12 from baseline based on the National Eye Institute grading scale. Conjunctival staining was scored from 0 to 3 on the scale (none, better to heavy, worse) in six regions of the cornea and summed for a total score of 0-18. | Posted | Mean | Standard Deviation | Score on a scale | Baseline to Week 4, Week 8 and Week 12 | Eyes | Eyes |
|
|
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| Secondary | Mean Schirmer Tear Test 1 Score | Schirmer Tear Test 1 score, measuring tear production, as measured by a Schirmer's test strip with anesthetic (mm/5min on a strip 0-35mm. 0 mm is worse, >15 indicates normal production) at week 4, 8 and 12 from Baseline. | Posted | Mean | Standard Deviation | Score on a scale | Baseline to Week 4, Week 8 and Week 12 | Eyes | Eyes |
|
|
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| Secondary | Tear Breakup Time (Seconds) | The time it takes (in seconds) for the tear film to break after blinking at Week 4, 8 and 12 from Baseline | Posted | Mean | Standard Deviation | Seconds | Baseline to Week 4, Week 8 and Week 12 | Eyes | Eyes |
|
|
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| Secondary | Tear Osmolarity | Tear osmolarity as measured by TearLab (275-307 is considered "homeostatic range") at Week 4, 8 and 12 from Baseline. | Posted | Mean | Standard Deviation | mOsM/L | Baseline to Week 4, Week 8 and Week 12 | Eyes | Eyes |
|
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| Secondary | Meibomian Gland Scores | Meibomian gland scoring on a scale of 1-4 (1 represents clear, liquid secretions and 4 is no secretions) in three regions (nasal, central, temporal) and summed for a single score between 3-12 at Week 4, 8 and 12 from baseline | Posted | Mean | Standard Deviation | Score on a scale | Baseline to Week 4, Week 8 and Week 12 | Eyes | Eyes |
|
|
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| Secondary | DEQ-5 Score | Dry Eye Questionnaire-5 (5 questions about dry eye symptoms rated from 0, or never to 5, or constantly) total score of 0-22 with higher scores representing worse symptoms at weeks 4, 8 and 12 from baseline | Posted | Mean | Standard Deviation | Score on a scale | Baseline to Week 4, Week 8 and Week 12 | Eyes | Eyes |
|
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| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Restasis and Dextenza | 10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes, as well as receiving Dextenza insertion in both lower lids. Cyclosporine: Used to increase tear production in patients who have dry eye caused by inflammation Dexamethasone Ophthalmic 0.4 Mg Ophthalmic Insert: Used to treat inflammation of the eye | 0 | 10 | 0 | 10 | 2 | 10 |
| EG002 | Restasis | 10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes Cyclosporine: Used to increase tear production in patients who have dry eye caused by inflammation | 0 | 10 | 0 | 10 | 0 | 10 |
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| Increased Corneal and Conjunctival Staining from Baseline | Eye disorders | Non-systematic Assessment | Increased corneal and conjunctival staining from baseline to exit visit. No treatment necessary. |
|
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| D000602 |
| Amino Acids, Peptides, and Proteins |
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
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