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This is a Phase 4, multicenter, single arm, 12 week study in subjects with dry eye disease, which is inadequately controlled by cyclosporine 0.05% ophthalmic emulsion.
This is a phase 4, multicenter, open-label, single-arm, 12-week study of subjects with dry eye disease that is inadequately controlled by cyclosporine (CsA) 0.05% ophthalmic emulsion. Subject enrollment will be classified by evidence of dry eye disease (ie, signs, symptoms, or both signs and symptoms). Treatment will be one drop of CsA 0.09% ophthalmic solution (Cequa) in each eye twice daily (BID) for 12 weeks. The study hypothesis is that CsA 0.09% ophthalmic solution will show improved clinical benefit in subjects whose dry eye signs and/or symptoms are inadequately controlled while on CsA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CequaTM (Cyclosporine 0.09%) ophthalmic solution | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CequaTM (Cyclosporine 0.09%) ophthalmic solution | Drug | One drop CequaTM (Cyclosporine 0.09%) ophthalmic solution in each eye twice daily, approximately 12 hours apart. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Baseline in Total Corneal Fluoroscein Staining Score | Scale for Corneal Staining as defined by the FDA/NEI: 0-4 (0-no staining, 4-severe staining). The higher number indicates more severe. The lower the number indicates less severe staining on the cornea | Week12 |
| Change From Baseline in Modified Dry Eye Scoring. | Based on questionnaire asked to subjects (sign and symptoms), modified symptom of dry eye score (range 0 to 100) will be assessed. Increase in score will indicate severity in the symptoms. | Week12 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Baseline for Conjunctival Staining Assessment | Based on Investigator's judgement, 6 areas of the conjunctiva will be evaluated in a low to moderate intensity. Scale for Conjunctival Staining defined: 0-6 (0 no staining, 6-severe staining). The higher the number indicates more severe. The lower the number indicates less severe staining on the conjunctival | Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eye Associates of Fort Myers, 4225 Evans Ave. | Fort Myers | Florida | 33901 | United States | ||
| Bowden Eye and Associates, 7205 Bonneval Road |
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| ID | Title | Description |
|---|---|---|
| FG000 | CequaTM (Cyclosporine 0.09%) Ophthalmic Solution | CequaTM (Cyclosporine 0.09%) ophthalmic solution: One drop CequaTM (Cyclosporine 0.09%) ophthalmic solution in each eye twice daily, approximately 12 hours apart. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CequaTM (Cyclosporine 0.09%) Ophthalmic Solution | CequaTM (Cyclosporine 0.09%) ophthalmic solution: One drop CequaTM (Cyclosporine 0.09%) ophthalmic solution in each eye twice daily, approximately 12 hours apart. |
| 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 | Mean Change in Baseline in Total Corneal Fluoroscein Staining Score | Scale for Corneal Staining as defined by the FDA/NEI: 0-4 (0-no staining, 4-severe staining). The higher number indicates more severe. The lower the number indicates less severe staining on the cornea | Posted | Mean | Standard Deviation | score on a scale | Week12 |
|
|
12 weeks
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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 | CequaTM (Cyclosporine 0.09%) Ophthalmic Solution | CequaTM (Cyclosporine 0.09%) ophthalmic solution: One drop CequaTM (Cyclosporine 0.09%) ophthalmic solution in each eye twice daily, approximately 12 hours apart. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Instillation Site Irritation | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head-Clinical Development | Sun Pharmaceutical Industries Limited | 2266455645 | 5689 | clinical.trial@sunpharma.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 | Dec 11, 2019 | Sep 4, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 25, 2023 | Sep 4, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| D007638 | Keratoconjunctivitis Sicca |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
| D007637 | Keratoconjunctivitis |
| D003231 | Conjunctivitis |
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| ID | Term |
|---|---|
| D016572 | Cyclosporine |
| D009883 | Ophthalmic Solutions |
| ID | Term |
|---|---|
| D003524 | Cyclosporins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
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| Changes From Baseline in Central Corneal Staining Score | Five areas of cornea will be evaluated on a 0 to 4 scale and value from 0 (absent) to 4 (severe) to each section will be allotted based on NEI grading scale | Week 12 |
| Mean Change in Baseline for Tear Osmolarity Score for Both Eyes | Tear osmolarity of both the eyes will be assessed and score (mOsm/L) will be allotted to each eye. Higher score will indicate severity of the disease (dry eye). Tear osmolarity OU was assessed using the TearLab Osmolarity System Test by collecting nanoliter volumes of tear fluid at each visit from each eyelid margin using the Osmolarity Test Pen and Test Card. Results were interpreted according to the provided instructions and scores (mOsm/L) for each eye were recorded. Normal, mild/moderate, and severe dry eyes had average tear osmolarity values of approximately 302+/-8 mOsm/L, 315+/-10 mOsm/L and 336+/022 mOsm/L, respectively. | Week 12 |
| Mean Change From Baseline in Frequency of Artificial Tear Product Use. | Based on entries in the subject diaries, frequency of artificial tear product use will be assessed. Frequency for artificial tear: This is number of times per day recorded in a daily diary log assessed at baseline and week 12. The higher the number the worse the outcome. The lower the number the better the outcome | Week 12 |
| Schirmer's Test Score | An unanesthetized Schirmer's test was performed in each eye at least 5 minutes after the lissamine green conjunctival staining to allow for any reflex tearing to subside. At each visit, strips were placed OU at the same time and timed for 5 min. Strips were removed after 5 min and the amount of wetting was recorded in mm and also marked with a line on the strip. The Investigator recorded a score for each eye. A score of greater than 10 mm in 5 minutes is accepted as normal. A score of less than 5 mm in 5 minutes indicates a tear deficiency. A score less than 10 mm in 5 minutes indicates a change from normal in tear production. | Week 12 |
| Percentage of Subjects Who Prefer Study Treatments Over Prior Treatment. | Subjects will be asked, which treatment they prefer for the management of the dry eye (prior treatment or study treatment). Note- For this outcome measure, participants were provided the option to not choose either treatment as the preferred treatment. | Week 12 |
| Jacksonville |
| Florida |
| 32256 |
| United States |
| Eye Center of N Florida, 2500 Martin Luther King Jr Blvd | Panama City | Florida | 32405 | United States |
| Kannarr Eye Care, 2521 N Broadway | Pittsburg | Kansas | 66762 | United States |
| Texas Eye and Laser Center, 1872 Norwood Dr. #200 | Hurst | Texas | 76054 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
|
|
|
| Primary | Change From Baseline in Modified Dry Eye Scoring. | Based on questionnaire asked to subjects (sign and symptoms), modified symptom of dry eye score (range 0 to 100) will be assessed. Increase in score will indicate severity in the symptoms. | Posted | Mean | Standard Deviation | score on a scale | Week12 |
|
|
|
|
| Secondary | Mean Change in Baseline for Conjunctival Staining Assessment | Based on Investigator's judgement, 6 areas of the conjunctiva will be evaluated in a low to moderate intensity. Scale for Conjunctival Staining defined: 0-6 (0 no staining, 6-severe staining). The higher the number indicates more severe. The lower the number indicates less severe staining on the conjunctival | Posted | Mean | Standard Deviation | score on a scale | Week 12 |
|
|
|
|
| Secondary | Changes From Baseline in Central Corneal Staining Score | Five areas of cornea will be evaluated on a 0 to 4 scale and value from 0 (absent) to 4 (severe) to each section will be allotted based on NEI grading scale | Posted | Mean | Standard Deviation | score on a scale | Week 12 |
|
|
|
|
| Secondary | Mean Change in Baseline for Tear Osmolarity Score for Both Eyes | Tear osmolarity of both the eyes will be assessed and score (mOsm/L) will be allotted to each eye. Higher score will indicate severity of the disease (dry eye). Tear osmolarity OU was assessed using the TearLab Osmolarity System Test by collecting nanoliter volumes of tear fluid at each visit from each eyelid margin using the Osmolarity Test Pen and Test Card. Results were interpreted according to the provided instructions and scores (mOsm/L) for each eye were recorded. Normal, mild/moderate, and severe dry eyes had average tear osmolarity values of approximately 302+/-8 mOsm/L, 315+/-10 mOsm/L and 336+/022 mOsm/L, respectively. | Posted | Mean | Standard Deviation | mOsm/L | Week 12 |
|
|
|
|
| Secondary | Mean Change From Baseline in Frequency of Artificial Tear Product Use. | Based on entries in the subject diaries, frequency of artificial tear product use will be assessed. Frequency for artificial tear: This is number of times per day recorded in a daily diary log assessed at baseline and week 12. The higher the number the worse the outcome. The lower the number the better the outcome | Posted | Mean | Standard Deviation | times product used/day | Week 12 |
|
|
|
|
| Secondary | Schirmer's Test Score | An unanesthetized Schirmer's test was performed in each eye at least 5 minutes after the lissamine green conjunctival staining to allow for any reflex tearing to subside. At each visit, strips were placed OU at the same time and timed for 5 min. Strips were removed after 5 min and the amount of wetting was recorded in mm and also marked with a line on the strip. The Investigator recorded a score for each eye. A score of greater than 10 mm in 5 minutes is accepted as normal. A score of less than 5 mm in 5 minutes indicates a tear deficiency. A score less than 10 mm in 5 minutes indicates a change from normal in tear production. | Posted | Mean | Standard Deviation | mm | Week 12 |
|
|
|
|
| Secondary | Percentage of Subjects Who Prefer Study Treatments Over Prior Treatment. | Subjects will be asked, which treatment they prefer for the management of the dry eye (prior treatment or study treatment). Note- For this outcome measure, participants were provided the option to not choose either treatment as the preferred treatment. | Posted | Number | percentage of participants | Week 12 |
|
|
|
| 0 |
| 134 |
| 0 |
| 134 |
| 20 |
| 134 |
| Instillation Site Pain | General disorders | Systematic Assessment |
|
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| D003229 |
| Conjunctival Diseases |
| D007634 | Keratitis |
| D003316 | Corneal Diseases |
| D010455 |
| Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D020313 | Specialty Uses of Chemicals |
OS: P-Value |
| Other |
Single group analysis |