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This is a safety extension enrolling subjects participating in Study OTX-101-2016-001 (NCT02688556)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OTX-101 0.09% | Experimental | 0.09% cyclosporine nanomicellar solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OTX-101 0.09% | Drug | 0.09% cyclosporine nanomicellar solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Number of subjects reporting any AEs | 40 weeks |
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Inclusion Criteria:
Exclusion Criteria:
-
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33469259 | Derived | Sheppard J, Bergmann M, Schechter BA, Luchs J, Ogundele A, Karpecki P. Phase 3 Efficacy (Worse-Eye Analysis) and Long-Term Safety Evaluation of OTX-101 in Patients with Keratoconjunctivitis Sicca. Clin Ophthalmol. 2021 Jan 12;15:129-140. doi: 10.2147/OPTH.S279364. eCollection 2021. |
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Group 1 and Group 2 consisted of subsets of subjects who received masked treatment with OTX-101 0.09% or with Vehicle, respectively, in OTX-101-2016-001. All subjects received open-label treatment with OTX-101 0.09% in OTX-101-2016-002.
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| ID | Title | Description |
|---|---|---|
| FG000 | OTX-101 0.09% to OTX-101 0.09% | One drop in each eye BID |
| FG001 | Vehicle to OTX-101 0.09% | One drop in each eye BID |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Intent to treat population; Group 1 and Group 2 consisted of subsets of subjects who received masked treatment with OTX-101 0.09% or with Vehicle, respectively, in OTX-101-2016-001. All subjects received open-label treatment with OTX-101 0.09% in OTX-101-2016-002
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 | 0.09% cyclosporine nanomicellar solution OTX-101 0.09%: 0.09% cyclosporine nanomicellar solution |
| BG001 | Group 2 | OTX-101 0.09%: 0.09% cyclosporine nanomicellar solution |
| 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 | Adverse Events | Number of subjects reporting any AEs | Safety population: Group 1 and Group 2 consisted of subsets of subjects who received masked treatment with OTX-101 0.09% or with Vehicle, respectively, in OTX-101-2016-001. All subjects received open-label treatment with OTX-101 0.09% in OTX-101-2016-002. | Posted | Number | Count of participants | 40 weeks |
|
Day 448
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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 | Group 1 | OTX-101 0.09%: 0.09% cyclosporine nanomicellar solution | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Osteoarthritis | Musculoskeletal and connective tissue 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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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 23, 2017 | Nov 14, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 10, 2017 | Nov 14, 2018 | SAP_001.pdf |
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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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| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 129 |
| 4 |
| 129 |
| 55 |
| 129 |
| EG001 | Group 2 | OTX-101 0.09%: 0.09% cyclosporine nanomicellar solution | 0 | 129 | 4 | 129 | 69 | 129 |
| Wound dehiscence | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Femur fracture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Vitreous detachment | Eye disorders | Systematic Assessment |
|
| Posterior capsule opacification | Eye disorders | Systematic Assessment |
|
| Blepharitis | Eye disorders | Systematic Assessment |
|
| Punctate keratitis | Eye disorders | Systematic Assessment |
|
| Instillation site reaction | General disorders | Systematic Assessment |
|
| Instillation site lacrimation | General disorders | Systematic Assessment |
|
| Instillation site pruritus | General disorders | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
|
| Eye irritation | Eye disorders | Systematic Assessment |
|
| Conjunctival haemorrhage | Eye disorders | Systematic Assessment |
|
| Instillation site pain | General disorders | Systematic Assessment |
|
| Intraocular pressure increased | Investigations | Systematic Assessment |
|
| Cataract | Eye disorders | Systematic Assessment |
|
| Cataract nuclear | Eye disorders | Systematic Assessment |
|
| Eye allergy | Eye disorders | Systematic Assessment |
|
| Retinal haemorrhage | Eye disorders | Systematic Assessment |
|
| Visual acuity reduced | Eye disorders | Systematic Assessment |
|
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| D007634 |
| Keratitis |
| D003316 | Corneal Diseases |
| D015352 | Dry Eye Syndromes |
| D007766 | Lacrimal Apparatus Diseases |