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This study will evaluate the efficacy of cyclosporine ophthalmic solution vs. other non-prescription treatments in patients with dry eye disease. Patient and physician assessments completed at baseline, at each follow-up visit (follow-up visits are variable as per physician discretion) and at final follow-up visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cyclosporine ophthalmic emulsion 0.05%, artificial tears | Drug | one drop, twice a day in each eye |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ocular Surface Disease Index (OSDI) Total Score at Baseline | The OSDI consists of 12 questions to assess visual function, ocular symptoms and environmental triggers related to dry eye. Each of the 12 questions is assessed using a 5-point scale (0=none of the time; 4 = all of the time) which is converted to a total score between 0-100. OSDI total scores of 0-12=normal (best), 13-22= mild ocular surface disease, 23-32 =moderate ocular surface disease, and 33-100=severe ocular surface disease (worst). | Baseline |
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| Measure | Description | Time Frame |
|---|---|---|
| Schirmer's Test With and Without Anesthesia at Baseline | Schirmer's Test with and without anesthesia at baseline. The Schirmer's test is performed on each eye with and without anesthesia (numbing eye drop). The amount of wetting produced by the eye was measured in millimeters using a graduated paper scale. The results indicate the presence of dry eye (Normal = greater than or equal to 15 millimeters (mm), Dry eye = less than 15 mm). A larger number correlates to better tear production, a smaller number correlates to reduced tear production. |
Inclusion Criteria:
Exclusion Criteria
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Patients can either:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wilson | North Carolina | United States |
Treatment for this study was per normal clinical practice and not assigned.
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| ID | Title | Description |
|---|---|---|
| FG000 | Restasis® Alone | cyclosporine ophthalmic emulsion 0.05% |
| FG001 | Artificial Tears Alone | |
| FG002 | Combination Treatments | |
| FG003 | Missing Treatment Information |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline |
| |||||||||||||
| 1-Year Follow-Up |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Restasis® Alone | cyclosporine ophthalmic emulsion 0.05% |
| BG001 | Artificial Tears Alone | |
| BG002 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Median |
| 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 | Ocular Surface Disease Index (OSDI) Total Score at Baseline | The OSDI consists of 12 questions to assess visual function, ocular symptoms and environmental triggers related to dry eye. Each of the 12 questions is assessed using a 5-point scale (0=none of the time; 4 = all of the time) which is converted to a total score between 0-100. OSDI total scores of 0-12=normal (best), 13-22= mild ocular surface disease, 23-32 =moderate ocular surface disease, and 33-100=severe ocular surface disease (worst). | Intent-to-treat, which included all patients who started the study (completed baseline visit) and were assessed for this outcome measure. 16 subjects did not complete this outcome measure assessment and were not included in the analysis. | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline |
|
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Serious adverse events and adverse events were not collected/assessed.
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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 | All Patients |
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Due to actual dry eye treatment used, data were not interpretable by separate treatment arms. Hence, Outcomes are only reported as a single group.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President, GHOSR | Allergan, Inc. | 714-246-4500 | clinicaltrials@allergan.com |
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| ID | Term |
|---|---|
| D007638 | Keratoconjunctivitis Sicca |
| ID | Term |
|---|---|
| D007637 | Keratoconjunctivitis |
| D003231 | Conjunctivitis |
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D003524 | Cyclosporins |
| D065346 | Lubricant Eye Drops |
| ID | Term |
|---|---|
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
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| Baseline |
| COMPLETED |
|
| NOT COMPLETED |
|
| Combination Treatments |
| BG003 | Missing Treatment Information |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Other Pre-specified | Schirmer's Test With and Without Anesthesia at Baseline | Schirmer's Test with and without anesthesia at baseline. The Schirmer's test is performed on each eye with and without anesthesia (numbing eye drop). The amount of wetting produced by the eye was measured in millimeters using a graduated paper scale. The results indicate the presence of dry eye (Normal = greater than or equal to 15 millimeters (mm), Dry eye = less than 15 mm). A larger number correlates to better tear production, a smaller number correlates to reduced tear production. | Intent-to-treat, which included all patients who started the study (completed baseline visit). | Posted | Mean | Standard Deviation | millimeters (mm) | Baseline |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
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 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
| D007634 |
| Keratitis |
| D003316 | Corneal Diseases |
| D015352 | Dry Eye Syndromes |
| D007766 | Lacrimal Apparatus Diseases |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D009883 | Ophthalmic Solutions |
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D054327 | Lubricants |
| D020313 | Specialty Uses of Chemicals |