Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The present study will test if administration of different concentrations of 1334H eyedrops will be effective in treatment of allergic conjunctivitis in people with 10 yrs of age or older.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SPARC1102 I | Experimental | 1334H 0.15% eye drops will be administered in both eyes at 3 occasions |
|
| SPARC1102 II | Experimental | 1334H 0.3% eye drops (solution) will be administered in both eyes at 3 occasions |
|
| SPARC1102 III | Experimental | 1334H 0.45% eye drops (solution)will be administered in both eyes at 3 occasions |
|
| Vehicle | Placebo Comparator | Placebo eye drops (solution)will be administered in both eyes at 3 occasions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPARC1102 I | Drug | SPARC1102 I will be administered in both eyes |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Ocular Itching | Ocular itching evaluated by the subject at 3, 5, and 7 minutes post-challenge (0-4 scale, allowing half unit increments with 0 representing none and 4 representing Incapacitating itch with an irresistible urge to rub) at Visit 5. | Up to 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Ciliary Redness Evaluated by the Investigator | Ciliary redness and episcleral redness were evaluated by the investigator at 7, 15, and 20 minutes post-CAC using a 4-point (0 indicating none and 4 indicating extremely severe i.e. large, numerous, dilated blood vessels characterized by unusually severe deep red color, regardless of grade of chemosis, which involves the entire vessel bed) scale with half-unit (1-step) increments allowed. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ORA Inc | Andover | Massachusetts | 01810 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 1334 H 0.15% | 1334H 0.15% eye drops will be administered in both eyes at 3 occasions 1334 H 0.15%: 1334H 0.15% eye drops (solution) will be administered in both eyes at 3 occasions |
| FG001 | 1334 H-0.3% | 1334H 0.3% eye drops (solution) will be administered in both eyes at 3 occasions 1334 H-0.3%: 1334H 0.3% eye drops (solution) will be administered in both eyes at 3 occasions |
| FG002 | 1334 H-0.45% | 1334H 0.45% eye drops (solution)will be administered in both eyes at 3 occasions 1334 H-0.45%: 1334H 0.45% eye drops (solution)will be administered in both eyes at 3 occasions |
| FG003 | Vehicle | Vehicle eye drops (solution)will be administered in both eyes at 3 occasions Placebo: Placebo eye drops (solution)will be administered in both eyes at 3 occasions |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 1334 H 0.15% | 1334H 0.15% eye drops will be administered in both eyes at 3 occasions 1334 H 0.15%: 1334H 0.15% eye drops (solution) will be administered in both eyes at 3 occasions |
| BG001 | 1334 H-0.3% |
| 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 | Ocular Itching | Ocular itching evaluated by the subject at 3, 5, and 7 minutes post-challenge (0-4 scale, allowing half unit increments with 0 representing none and 4 representing Incapacitating itch with an irresistible urge to rub) at Visit 5. | Of the 122 subjects enrolled in the study, a total of 8 subjects did not complete the study: 1 in the 1334H 0.15% group, 4 in the 1334H 0.3% group, 2 in the 1334H 0.45% group and 1 in the vehicle treated group. The Per Protocol population, comprised of all subjects who completed the study with no protocol violations, totaled 107 subjects. | Posted | Mean | Standard Deviation | units on a scale | Up to 28 days |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 1334 H 0.15% | 1334H 0.15% eye drops will be administered in both eyes at 3 occasions 1334 H 0.15%: 1334H 0.15% eye drops (solution) will be administered in both eyes at 3 occasions |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diverticulitis | Infections and infestations | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Visual Acuity Reduced | Eye disorders | Systematic Assessment |
Of the total of 122 subjects, 8 subjects did not complete the study: 114 subjects completed the study, PP population, comprised of all subjects who completed the study with no protocol violations, totaled 107 subjects.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Shravanti Bhowmik, MD | SPARC | shravanti.bhowmik@sparcmail.com |
Not provided
| ID | Term |
|---|---|
| D003233 | Conjunctivitis, Allergic |
| ID | Term |
|---|---|
| D003231 | Conjunctivitis |
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
| D006969 | Hypersensitivity, Immediate |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| SPARC1102 II |
| Drug |
SPARC1102 II will be administered in both eyes |
|
| SPARC1102 III | Drug | SPARC1102 III will be administered in both eyes |
|
| Vehicle | Drug | Vehicle will be administered in both eyes |
|
| Up to 4 weeks |
1334H 0.3% eye drops (solution) will be administered in both eyes at 3 occasions
1334 H-0.3%: 1334H 0.3% eye drops (solution) will be administered in both eyes at 3 occasions
| BG002 | 1334 H-0.45% | 1334H 0.45% eye drops (solution)will be administered in both eyes at 3 occasions 1334 H-0.45%: 1334H 0.45% eye drops (solution)will be administered in both eyes at 3 occasions |
| BG003 | Placebo | Placebo eye drops (solution)will be administered in both eyes at 3 occasions Placebo: Placebo eye drops (solution)will be administered in both eyes at 3 occasions |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | 1334 H-0.3% | 1334H 0.3% eye drops (solution) will be administered in both eyes at 3 occasions 1334 H-0.3%: 1334H 0.3% eye drops (solution) will be administered in both eyes at 3 occasions |
| OG002 | 1334 H-0.45% | 1334H 0.45% eye drops (solution)will be administered in both eyes at 3 occasions 1334 H-0.45%: 1334H 0.45% eye drops (solution)will be administered in both eyes at 3 occasions |
| OG003 | Vehicle | Vehicle eye drops (solution)will be administered in both eyes at 3 occasions Placebo: Placebo eye drops (solution)will be administered in both eyes at 3 occasions |
|
|
| Secondary | Ciliary Redness Evaluated by the Investigator | Ciliary redness and episcleral redness were evaluated by the investigator at 7, 15, and 20 minutes post-CAC using a 4-point (0 indicating none and 4 indicating extremely severe i.e. large, numerous, dilated blood vessels characterized by unusually severe deep red color, regardless of grade of chemosis, which involves the entire vessel bed) scale with half-unit (1-step) increments allowed. | Posted | Mean | Standard Deviation | units on a scale | Up to 4 weeks |
|
|
|
| 0 |
| 31 |
| 6 |
| 31 |
| EG001 | 1334 H-0.3% | 1334H 0.3% eye drops (solution) will be administered in both eyes at 3 occasions 1334 H-0.3%: 1334H 0.3% eye drops (solution) will be administered in both eyes at 3 occasions | 1 | 30 | 6 | 30 |
| EG002 | 1334 H-0.45% | 1334H 0.45% eye drops (solution)will be administered in both eyes at 3 occasions 1334 H-0.45%: 1334H 0.45% eye drops (solution)will be administered in both eyes at 3 occasions | 0 | 31 | 12 | 31 |
| EG003 | Vehicle | Vehicle eye drops (solution)will be administered in both eyes at 3 occasions Placebo: Placebo eye drops (solution)will be administered in both eyes at 3 occasions | 0 | 30 | 11 | 30 |
| anterior chamber cell | Eye disorders |
|
| Anterior Chamber Pigmentation | Eye disorders | Systematic Assessment |
|
| Corneal opacity | Eye disorders | Systematic Assessment |
|
| Dry eye | Eye disorders | Systematic Assessment |
|
| Eye irritation | Eye disorders | Systematic Assessment |
|
| Eyelid Exfoliation | Eye disorders | Systematic Assessment |
|
| Foreign Body Sensation in Eyes | Eye disorders | Systematic Assessment |
|
| Ocular Hyperaemia | Eye disorders | Systematic Assessment |
|
| Corneal Abrasion | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Sinus Headache | Nervous system disorders | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Diverticulitis | Infections and infestations | Systematic Assessment |
|
| Throat Irritation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Eyelid Oedema | Eye disorders | Systematic Assessment |
|
Not provided
| D006967 |
| Hypersensitivity |
| D007154 | Immune System Diseases |
| 15 minutes post challenge |
|
| 7 minutes post challenge |
|