Allergic Conjunctivitis
Conditions
Brief summary
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.
Interventions
DRUGSPARC1102 II
SPARC1102 II will be administered in both eyes
DRUGSPARC1102 I
SPARC1102 I will be administered in both eyes
DRUGSPARC1102 III
SPARC1102 III will be administered in both eyes
DRUGVehicle
Vehicle will be administered in both eyes
Sponsors
Sun Pharma Advanced Research Company Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
10 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Signed informed consent form and HIPAA document * Willing and able to comply with all study procedures * Be at least 10 years of age at the time of enrollment * LogMar 0.7 or better, in each eye * History of ocular allergies, and a positive skin and ocular allergic reaction to allergens * A negative urine pregnancy test if female of childbearing potential and must use adequate birth control throughout the study period
Exclusion criteria
* have known contraindications or sensitivities to the use of any of the study medications(s) or their components; * have any ocular condition that, in the opinion of the investigator, could affect the subject's safety or trial parameters (including but not limited to narrow angle glaucoma, clinically significant blepharitis, follicular conjunctivitis, iritis, pterygium or a diagnosis of dry eye); * have a current diagnosis or history of open angle glaucoma or ocular hypertension; * have had ocular surgical intervention within three (3) months prior to Visit 1 or during the study and/or a history of refractive surgery within the past 6 months; * have a known history of retinal detachment, diabetic retinopathy, or progressive retinal disease; * have the presence of an active ocular infection (bacterial, viral or fungal), positive history of an ocular herpetic infection, or preauricular lymphadenopathy at any visit; * manifest signs or symptoms of clinically active allergic conjunctivitis in either eye at screening or during study * have used an investigational drug or device within 30 days of the study or be concurrently enrolled in another investigational drug or device study within 30 days of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ocular Itching | Up to 28 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ciliary Redness Evaluated by the Investigator | Up to 4 weeks | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 31 |
| 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 | 30 |
| 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 | 31 |
| 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 | 30 |
| Total | 122 |
Baseline characteristics
| Characteristic | 1334 H 0.15% | 1334 H-0.3% | 1334 H-0.45% | Placebo | Total |
|---|---|---|---|---|---|
| Age, Continuous | 33.4 years STANDARD_DEVIATION 11.58 | 34.8 years STANDARD_DEVIATION 15.42 | 33.7 years STANDARD_DEVIATION 15.94 | 40.6 years STANDARD_DEVIATION 13.57 | 35.6 years STANDARD_DEVIATION 14.35 |
| Sex: Female, Male Female | 18 Participants | 16 Participants | 22 Participants | 21 Participants | 77 Participants |
| Sex: Female, Male Male | 13 Participants | 14 Participants | 9 Participants | 9 Participants | 45 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 6 / 31 | 6 / 30 | 12 / 31 | 11 / 30 |
| serious Total, serious adverse events | 0 / 31 | 1 / 30 | 0 / 31 | 0 / 30 |
Outcome results
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.
Time frame: Up to 28 days
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 1334 H 0.15% | Ocular Itching | 7 minutes post challenge | 1.27 units on a scale | Standard Deviation 1.085 |
| 1334 H 0.15% | Ocular Itching | 3 minutes post challenge | 0.92 units on a scale | Standard Deviation 0.989 |
| 1334 H 0.15% | Ocular Itching | 5 minutes post challenge | 1.34 units on a scale | Standard Deviation 1.068 |
| 1334 H-0.3% | Ocular Itching | 3 minutes post challenge | 1.01 units on a scale | Standard Deviation 0.931 |
| 1334 H-0.3% | Ocular Itching | 5 minutes post challenge | 1.40 units on a scale | Standard Deviation 1.108 |
| 1334 H-0.3% | Ocular Itching | 7 minutes post challenge | 1.57 units on a scale | Standard Deviation 1.174 |
| 1334 H-0.45% | Ocular Itching | 5 minutes post challenge | 1.23 units on a scale | Standard Deviation 1.109 |
| 1334 H-0.45% | Ocular Itching | 7 minutes post challenge | 1.16 units on a scale | Standard Deviation 1.125 |
| 1334 H-0.45% | Ocular Itching | 3 minutes post challenge | 0.86 units on a scale | Standard Deviation 0.889 |
| Vehicle | Ocular Itching | 3 minutes post challenge | 2.06 units on a scale | Standard Deviation 0.912 |
| Vehicle | Ocular Itching | 7 minutes post challenge | 1.88 units on a scale | Standard Deviation 0.854 |
| Vehicle | Ocular Itching | 5 minutes post challenge | 2.12 units on a scale | Standard Deviation 0.854 |
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.
Time frame: Up to 4 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 1334 H 0.15% | Ciliary Redness Evaluated by the Investigator | 20 minutes post challenge | 0.75 units on a scale | Standard Deviation 0.504 |
| 1334 H 0.15% | Ciliary Redness Evaluated by the Investigator | 7 minutes post challenge | 0.34 units on a scale | Standard Deviation 0.344 |
| 1334 H 0.15% | Ciliary Redness Evaluated by the Investigator | 15 minutes post challenge | 0.70 units on a scale | Standard Deviation 0.433 |
| 1334 H-0.3% | Ciliary Redness Evaluated by the Investigator | 20 minutes post challenge | 1.05 units on a scale | Standard Deviation 0.7 |
| 1334 H-0.3% | Ciliary Redness Evaluated by the Investigator | 7 minutes post challenge | 0.64 units on a scale | Standard Deviation 0.609 |
| 1334 H-0.3% | Ciliary Redness Evaluated by the Investigator | 15 minutes post challenge | 0.99 units on a scale | Standard Deviation 0.74 |
| 1334 H-0.45% | Ciliary Redness Evaluated by the Investigator | 15 minutes post challenge | 0.73 units on a scale | Standard Deviation 0.472 |
| 1334 H-0.45% | Ciliary Redness Evaluated by the Investigator | 20 minutes post challenge | 0.88 units on a scale | Standard Deviation 0.553 |
| 1334 H-0.45% | Ciliary Redness Evaluated by the Investigator | 7 minutes post challenge | 0.50 units on a scale | Standard Deviation 0.275 |
| Vehicle | Ciliary Redness Evaluated by the Investigator | 20 minutes post challenge | 1.04 units on a scale | Standard Deviation 0.571 |
| Vehicle | Ciliary Redness Evaluated by the Investigator | 7 minutes post challenge | 0.62 units on a scale | Standard Deviation 0.446 |
| Vehicle | Ciliary Redness Evaluated by the Investigator | 15 minutes post challenge | 0.92 units on a scale | Standard Deviation 0.543 |