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To evaluate the efficacy and safety of two concentrations of PRT-2761 as a topical ophthalmic solution for the treatment of the signs and symptoms of acute and chronic allergic conjunctivitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRT-2761 0.5% | Experimental |
| |
| PRT-2761 1% | Experimental |
| |
| Patanol | Active Comparator |
| |
| Pred-forte | Active Comparator |
| |
| PRT-2761 0% | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRT-2761 0.5% | Drug | Six drops in each eye over a 17 day period. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Ocular Itching at 5, 7, and 10 Minutes Post CAC on Day 1 | Ocular Itching was assessed by a trained investigator post-conjunctival allergen challenge (CAC) on a 0 to 4 scale (0=none (best/no itching) to 4=severe (worst/most itching). The ocular itching was averaged across all subjects at each time point. | post CAC exposure at 5, 7, and 10 minutes post CAC on Day 1 |
| Ocular Itching at 5, 7, and 10 Minutes Post CAC on Day 15 | Ocular Itching was assessed by the subjects using a 0 to 4 point scale(0=none (best/no itching) to 4=severe (worst/most itching)). The ocular itching was averaged across all subjects at each time point. | post CAC exposure at 5, 7, and 10 minutes post CAC on Day 15 |
| Conjunctival Redness at 7, 15, and 20 Minutes Post CAC on Day 1 | Conjunctival Redness was assessed by a trained investigator post-conjunctival allergen challenge (CAC) on a 0 to 4 scale (0=none (best/no redness) to 4=severe (worst/most redness)). The conjunctival redness was averaged across all subjects at each time point. | post CAC exposure at 7, 15, and 20 minutes post-CAC on Day 1. |
| Conjunctival Redness at 7, 15, and 20 Minutes Post CAC on Day 15 | Conjunctival Redness was assessed by a trained investigator post-conjunctival allergen challenge (CAC) on a 0 to 4 scale (0=none (best/no redness) to 4=severe (worst/most redness)). The conjunctival redness was averaged across all subjects at each time point. | post CAC exposure at 7, 15, and 20 minutes post-CAC on Day 15. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Andover Eye Associates | Andover | Massachusetts | 01810 | United States |
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One hundred and twenty participants enrolled and 97 subjects completed the study. Participant flow and baseline characteristics are presented for 120 subjects that met all inclusion, none of the exclusion criteria, and were randomized to receive one of five treatments based on the randomization list.
Subjects were recruited from one site in the US.
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| ID | Title | Description |
|---|---|---|
| FG000 | PRT-2761 0.5% | PRT-2761 0.5%: Six drops in each eye over a 17 day period. |
| FG001 | PRT-2761 1% | PRT-2761 1%: Six drops in each eye over a 17 day period. |
| FG002 | Patanol | Patanol: Six drops in each eye over a 17 day period. |
| FG003 | PRT-2761 0% | PRT-2761 0%: Six drops in each eye over a 17 day period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | PRT-2761 0.5% | PRT-2761 0.5%: Six drops in each eye over a 17 day period. |
| BG001 | PRT-2761 1% | PRT-2761 1%: Six drops in each eye over a 17 day period. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 Itching at 5, 7, and 10 Minutes Post CAC on Day 1 | Ocular Itching was assessed by a trained investigator post-conjunctival allergen challenge (CAC) on a 0 to 4 scale (0=none (best/no itching) to 4=severe (worst/most itching). The ocular itching was averaged across all subjects at each time point. | All Randomized Participants Population - All participants who received study treatment. Note: Pred forte subjects receive Patanol up to and including Visit 5a and are analyzed as Patanol subjects for those visits. | Posted | Mean | Standard Deviation | units on a scale | post CAC exposure at 5, 7, and 10 minutes post CAC on Day 1 |
|
Adverse events were collected through study completion, an average of 9 weeks. All subjects who received study medication were evaluable for the safety analysis.
Throughout the visits, staff collected all Adverse Events reported, elicited, or observed.
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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 | PRT-2761 0.5% | PRT-2761 0.5%: Six drops in each eye over a 17 day period. | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Visual Acuity Reduced | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Caitlin Pearson | Ora, Inc | 978-685-8900 | cpearson@oraclinical.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 | Oct 18, 2017 | May 5, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 27, 2017 | May 9, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003233 | Conjunctivitis, Allergic |
| ID | Term |
|---|---|
| D003231 | Conjunctivitis |
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
| D006969 | Hypersensitivity, Immediate |
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| ID | Term |
|---|---|
| D000069605 | Olopatadine Hydrochloride |
| D008775 | Methylprednisolone |
| ID | Term |
|---|---|
| D003990 | Dibenzoxepins |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| PRT-2761 1% |
| Drug |
Six drops in each eye over a 17 day period. |
|
| Patanol | Drug | Six drops in each eye over a 17 day period. |
|
| Pred-forte | Drug | Four drops in each eye over a 3 day period. |
|
| PRT-2761 0% | Drug | Six drops in each eye over a 17 day period. |
|
| BG002 | Patanol | Patanol: Six drops in each eye over a 17 day period. |
| BG003 | PRT-2761 0% | PRT-2761 0%: Six drops in each eye over a 17 day period. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Iris Color | Count of Participants | Participants |
|
| Average Post-CAC Itching Score at Baseline | Count of Participants | Participants |
|
| Allergen Type | Count of Participants | Participants |
|
| Confocal Participation | Count of Participants | Participants |
|
PRT-2761 1%: Six drops in each eye over a 17 day period. |
| OG002 | Patanol | Patanol: Six drops in each eye over a 17 day period. |
| OG003 | PRT-2761 0% | PRT-2761 0%: Six drops in each eye over a 17 day period. |
|
|
| Primary | Ocular Itching at 5, 7, and 10 Minutes Post CAC on Day 15 | Ocular Itching was assessed by the subjects using a 0 to 4 point scale(0=none (best/no itching) to 4=severe (worst/most itching)). The ocular itching was averaged across all subjects at each time point. | All Randomized Participants Population - All participants who received study treatment. Note: Pred forte subjects receive Patanol up to and including Visit 5a and are analyzed as Patanol subjects for those visits. | Posted | Mean | Standard Deviation | units on a scale | post CAC exposure at 5, 7, and 10 minutes post CAC on Day 15 |
|
|
|
| Primary | Conjunctival Redness at 7, 15, and 20 Minutes Post CAC on Day 1 | Conjunctival Redness was assessed by a trained investigator post-conjunctival allergen challenge (CAC) on a 0 to 4 scale (0=none (best/no redness) to 4=severe (worst/most redness)). The conjunctival redness was averaged across all subjects at each time point. | All Randomized Participants Population - All participants who received study treatment. Note: Pred forte subjects receive Patanol up to and including Visit 5a and are analyzed as Patanol subjects for those visits. | Posted | Mean | Standard Deviation | units on a scale | post CAC exposure at 7, 15, and 20 minutes post-CAC on Day 1. |
|
|
|
| Primary | Conjunctival Redness at 7, 15, and 20 Minutes Post CAC on Day 15 | Conjunctival Redness was assessed by a trained investigator post-conjunctival allergen challenge (CAC) on a 0 to 4 scale (0=none (best/no redness) to 4=severe (worst/most redness)). The conjunctival redness was averaged across all subjects at each time point. | All Randomized Participants Population - All participants who received study treatment. Note: Pred forte subjects receive Patanol up to and including Visit 5a. | Posted | Mean | Standard Deviation | units on a scale | post CAC exposure at 7, 15, and 20 minutes post-CAC on Day 15. |
|
|
|
| 32 |
| 0 |
| 32 |
| 4 |
| 32 |
| EG001 | PRT-2761 1% | PRT-2761 1%: Six drops in each eye over a 17 day period. | 0 | 29 | 0 | 29 | 9 | 29 |
| EG002 | Patanol | Patanol: Six drops in each eye over a 17 day period. | 0 | 30 | 0 | 30 | 1 | 30 |
| EG003 | PRT-2761 0% | PRT-2761 0%: Six drops in each eye over a 17 day period. | 0 | 29 | 0 | 29 | 7 | 29 |
| Conjunctival Haemorrhage | Eye disorders | Systematic Assessment |
|
| Conjunctival Pigmentation | Eye disorders | Systematic Assessment |
|
| Corneal Opacity | Eye disorders | Systematic Assessment |
|
| Dry Eye | Eye disorders | Systematic Assessment |
|
| Eye Discharge | Eye disorders | Systematic Assessment |
|
| Eyelid Oedema | Eye disorders | Systematic Assessment |
|
| Meibomian Gland Dysfunction | Eye disorders | Systematic Assessment |
|
| Punctate Keratitis | Eye disorders | Systematic Assessment |
|
| Retinal Haemorrhage | Eye disorders | Systematic Assessment |
|
| Skin Discolouration | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Palpitations | Cardiac disorders | Systematic Assessment |
|
| Abdominal Discomfort | Gastrointestinal disorders | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
|
| Irritable Bowel Syndrome | Gastrointestinal disorders | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | Systematic Assessment |
|
| Carpal Tunnel Syndrome | Nervous system disorders | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | Systematic Assessment |
|
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| D006967 |
| Hypersensitivity |
| D007154 | Immune System Diseases |
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
|
| 7 minutes post-CAC |
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| 10 minutes post-CAC |
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| 15 minutes post-CAC |
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| 20 minutes post-CAC |
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| 15 minutes post-CAC |
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| 20 minutes post-CAC |
|
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