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This is a randomized, double-masked, vehicle-controlled study of the safety and efficacy of OTX-101 (0.09% cyclosporine nanomicellar solution) in the treatment of keratoconjunctivitis sicca to be conducted at approximately 50 sites.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OTX-101 0.09% | Experimental | 0.09% cyclosporine nanomicellar ophthalmic solution |
|
| Vehicle | Placebo Comparator | vehicle of OTX-101 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cyclosporine | Drug |
|
| |
| vehicle of OTX-101 |
| Measure | Description | Time Frame |
|---|---|---|
| Tear Production | Percentage of Eyes with Increase from Baseline of ≥ 10 mm in Schirmer's Test Score | Baseline and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Conjunctival Staining | change from baseline in total conjunctival staining score (lissamine green, modified National Eye Institute scale) at 12 weeks. Conjunctival Lissamine Green Staining Grades ranged from 0 (No punctate stain in zone) to 3 (Densely concentrated micropunctate stain spots) | Baseline and 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Martel Eye Medical Group | Rancho Cordova | California | 95670 | United States | ||
| Cincinnati Eye Institute |
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One subject in OTX-101 0.09% group, was never treated with study medication and is not included in any of analysis sets Additionally, because the subjects in the ITT analysis set were analyzed as randomized, one subject who erroneously received OTX-101 0.09%, was included in the Vehicle group for purposes of efficacy analysis.
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| ID | Title | Description |
|---|---|---|
| FG000 | OTX-101 0.09% | 0.09% cyclosporine nanomicellar ophthalmic solution |
| FG001 | Vehicle | vehicle of OTX-101 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Intent to treat population
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| ID | Title | Description |
|---|---|---|
| BG000 | OTX-101 0.09% | 0.09% cyclosporine nanomicellar ophthalmic solution |
| BG001 | Vehicle | vehicle of OTX-101 |
| 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 | Tear Production | Percentage of Eyes with Increase from Baseline of ≥ 10 mm in Schirmer's Test Score | Intent to treat population | Posted | Number | Percentage of eyes | Baseline and 12 weeks |
|
|
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 | OTX-101 0.09% | 0.09% cyclosporine nanomicellar ophthalmic solution. A total of 744 subjects were included in the Safety population, with 372 subjects in the OTX-101 0.09% group and 372 subjects in the Vehicle group. The only difference between the ITT and the Safety populations is that Subject 14-003 was analyzed in the Safety population according to the treatment received, which was OTX-101 0.09% |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctival hyperaemia | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| SPARC | Sun Pharma Advanced Research Company Limited | +912266455645 | clinical.trials@sparcmail.com |
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| ID | Term |
|---|---|
| D007638 | Keratoconjunctivitis Sicca |
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007637 | Keratoconjunctivitis |
| D003231 | Conjunctivitis |
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D016572 | Cyclosporine |
| ID | Term |
|---|---|
| D003524 | Cyclosporins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
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| Drug |
|
| Central Corneal Staining |
change from baseline in central corneal staining score (fluorescein, modified NEI/FDA scale) at 12 weeks. The Expanded National Eye Institute (NEI)/Industry Workshop Scale for Corneal Staining Score was used to grade each of the 5 areas of the cornea on a 0 (No punctate stain in area) to 4 (Severe diffuse (coalescent) macropunctate stain of the area) scale. |
| Baseline and 12 weeks |
| Symptom Score | change from baseline in modified Symptom Assessment in Dry Eye (SANDE) score at 12 weeks. A modified SANDE instrument was used to evaluate dry eye symptoms at each visit. Subjects were asked to indicate:
Negative change from baseline indicates improvement. | Baseline and 12 weeks |
| Edgewood |
| Kentucky |
| 41017 |
| United States |
| Fifth Avenue Eye Associates | New York | New York | 10028 | United States |
| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Participants |
|
|
| Secondary | Conjunctival Staining | change from baseline in total conjunctival staining score (lissamine green, modified National Eye Institute scale) at 12 weeks. Conjunctival Lissamine Green Staining Grades ranged from 0 (No punctate stain in zone) to 3 (Densely concentrated micropunctate stain spots) | Intent to treat population | Posted | Mean | Standard Deviation | score on a scale | Baseline and 12 weeks |
|
|
|
| Secondary | Central Corneal Staining | change from baseline in central corneal staining score (fluorescein, modified NEI/FDA scale) at 12 weeks. The Expanded National Eye Institute (NEI)/Industry Workshop Scale for Corneal Staining Score was used to grade each of the 5 areas of the cornea on a 0 (No punctate stain in area) to 4 (Severe diffuse (coalescent) macropunctate stain of the area) scale. | Intent to treat population | Posted | Mean | Standard Deviation | score on a scale | Baseline and 12 weeks |
|
|
|
| Secondary | Symptom Score | change from baseline in modified Symptom Assessment in Dry Eye (SANDE) score at 12 weeks. A modified SANDE instrument was used to evaluate dry eye symptoms at each visit. Subjects were asked to indicate:
Negative change from baseline indicates improvement. | Intent to treat population | Posted | Mean | Standard Deviation | score on a scale | Baseline and 12 weeks |
|
|
|
| 1 |
| 372 |
| 6 |
| 372 |
| 130 |
| 372 |
| EG001 | Vehicle | vehicle of OTX-101 A total of 744 subjects were included in the Safety population, with 372 subjects in the OTX-101 0.09% group and 372 subjects in the Vehicle group. The only difference between the ITT and the Safety populations is that Subject 14-003 was analyzed in the Safety population according to the treatment received, which was OTX-101 0.09% | 0 | 372 | 2 | 372 | 66 | 372 |
| Pneumonia | Infections and infestations | Systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Subdural haematoma | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Spinal column stenosis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | Systematic Assessment |
|
| Perforated ulcer | General disorders | Systematic Assessment |
|
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Blepharitis | Eye disorders | Systematic Assessment |
|
| Eye irritation | Eye disorders | Systematic Assessment |
|
| Eye pruritus | Eye disorders | Systematic Assessment |
|
| Instillation site pain | General disorders | Systematic Assessment |
|
| Instillation site lacrimation | General disorders | Systematic Assessment |
|
| Instillation site reaction | Eye disorders | Systematic Assessment |
|
| Sinusitis | Eye disorders | Systematic Assessment |
|
| Urinary tract infection | Eye disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Foreign body sensation in eyes | Eye disorders | Systematic Assessment |
|
| Conjunctival haemorrhage | Eye disorders | Systematic Assessment |
|
| Posterior capsule opacification | Eye disorders | Systematic Assessment |
|
| Punctate keratitis | Eye disorders | Systematic Assessment |
|
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| D007634 |
| Keratitis |
| D003316 | Corneal Diseases |
| D007766 | Lacrimal Apparatus Diseases |
| D010455 |
| Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |