Trial Outcomes & Findings for Effect of Different Concentrations of SPARC1102 on Allergic Conjunctivitis (NCT NCT01320553)
NCT ID: NCT01320553
Last Updated: 2016-06-24
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
122 participants
Primary outcome timeframe
Up to 28 days
Results posted on
2016-06-24
Participant Flow
Participant milestones
| Measure |
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
|
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
|
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
|
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
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
31
|
30
|
31
|
30
|
|
Overall Study
COMPLETED
|
30
|
26
|
29
|
29
|
|
Overall Study
NOT COMPLETED
|
1
|
4
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Different Concentrations of SPARC1102 on Allergic Conjunctivitis
Baseline characteristics by cohort
| Measure |
1334 H 0.15%
n=31 Participants
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
|
1334 H-0.3%
n=30 Participants
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
|
1334 H-0.45%
n=31 Participants
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
|
Placebo
n=30 Participants
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
|
Total
n=122 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
33.4 years
STANDARD_DEVIATION 11.58 • n=5 Participants
|
34.8 years
STANDARD_DEVIATION 15.42 • n=7 Participants
|
33.7 years
STANDARD_DEVIATION 15.94 • n=5 Participants
|
40.6 years
STANDARD_DEVIATION 13.57 • n=4 Participants
|
35.6 years
STANDARD_DEVIATION 14.35 • n=21 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
77 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
45 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Up to 28 daysPopulation: 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.
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.
Outcome measures
| Measure |
1334 H 0.15%
n=29 Participants
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
|
1334 H-0.3%
n=24 Participants
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
|
1334 H-0.45%
n=26 Participants
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
|
Vehicle
n=28 Participants
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
|
|---|---|---|---|---|
|
Ocular Itching
7 minutes post challenge
|
1.27 units on a scale
Standard Deviation 1.085
|
1.57 units on a scale
Standard Deviation 1.174
|
1.16 units on a scale
Standard Deviation 1.125
|
1.88 units on a scale
Standard Deviation 0.854
|
|
Ocular Itching
5 minutes post challenge
|
1.34 units on a scale
Standard Deviation 1.068
|
1.40 units on a scale
Standard Deviation 1.108
|
1.23 units on a scale
Standard Deviation 1.109
|
2.12 units on a scale
Standard Deviation 0.854
|
|
Ocular Itching
3 minutes post challenge
|
0.92 units on a scale
Standard Deviation 0.989
|
1.01 units on a scale
Standard Deviation 0.931
|
0.86 units on a scale
Standard Deviation 0.889
|
2.06 units on a scale
Standard Deviation 0.912
|
SECONDARY outcome
Timeframe: Up to 4 weeksCiliary 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.
Outcome measures
| Measure |
1334 H 0.15%
n=30 Participants
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
|
1334 H-0.3%
n=26 Participants
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
|
1334 H-0.45%
n=29 Participants
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
|
Vehicle
n=29 Participants
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
|
|---|---|---|---|---|
|
Ciliary Redness Evaluated by the Investigator
20 minutes post challenge
|
0.75 units on a scale
Standard Deviation 0.504
|
1.05 units on a scale
Standard Deviation 0.700
|
0.88 units on a scale
Standard Deviation 0.553
|
1.04 units on a scale
Standard Deviation 0.571
|
|
Ciliary Redness Evaluated by the Investigator
15 minutes post challenge
|
0.70 units on a scale
Standard Deviation 0.433
|
0.99 units on a scale
Standard Deviation 0.740
|
0.73 units on a scale
Standard Deviation 0.472
|
0.92 units on a scale
Standard Deviation 0.543
|
|
Ciliary Redness Evaluated by the Investigator
7 minutes post challenge
|
0.34 units on a scale
Standard Deviation 0.344
|
0.64 units on a scale
Standard Deviation 0.609
|
0.50 units on a scale
Standard Deviation 0.275
|
0.62 units on a scale
Standard Deviation 0.446
|
Adverse Events
1334 H 0.15%
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
1334 H-0.3%
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
1334 H-0.45%
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Vehicle
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
1334 H 0.15%
n=31 participants at risk
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
|
1334 H-0.3%
n=30 participants at risk
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
|
1334 H-0.45%
n=31 participants at risk
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
|
Vehicle
n=30 participants at risk
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
|
|---|---|---|---|---|
|
Infections and infestations
Diverticulitis
|
0.00%
0/31
|
3.3%
1/30 • Number of events 1
|
0.00%
0/31
|
0.00%
0/30
|
Other adverse events
| Measure |
1334 H 0.15%
n=31 participants at risk
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
|
1334 H-0.3%
n=30 participants at risk
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
|
1334 H-0.45%
n=31 participants at risk
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
|
Vehicle
n=30 participants at risk
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
|
|---|---|---|---|---|
|
Eye disorders
Visual Acuity Reduced
|
3.2%
1/31 • Number of events 1
|
0.00%
0/30
|
9.7%
3/31 • Number of events 3
|
6.7%
2/30 • Number of events 2
|
|
Eye disorders
anterior chamber cell
|
0.00%
0/31
|
0.00%
0/30
|
0.00%
0/31
|
3.3%
1/30 • Number of events 1
|
|
Eye disorders
Anterior Chamber Pigmentation
|
3.2%
1/31 • Number of events 1
|
0.00%
0/30
|
0.00%
0/31
|
0.00%
0/30
|
|
Eye disorders
Corneal opacity
|
0.00%
0/31
|
0.00%
0/30
|
0.00%
0/31
|
3.3%
1/30 • Number of events 1
|
|
Eye disorders
Dry eye
|
0.00%
0/31
|
3.3%
1/30 • Number of events 1
|
0.00%
0/31
|
0.00%
0/30
|
|
Eye disorders
Eye irritation
|
0.00%
0/31
|
0.00%
0/30
|
3.2%
1/31 • Number of events 1
|
0.00%
0/30
|
|
Eye disorders
Eyelid Exfoliation
|
0.00%
0/31
|
3.3%
1/30 • Number of events 1
|
0.00%
0/31
|
0.00%
0/30
|
|
Eye disorders
Foreign Body Sensation in Eyes
|
0.00%
0/31
|
0.00%
0/30
|
3.2%
1/31 • Number of events 1
|
0.00%
0/30
|
|
Eye disorders
Ocular Hyperaemia
|
0.00%
0/31
|
0.00%
0/30
|
0.00%
0/31
|
3.3%
1/30
|
|
Injury, poisoning and procedural complications
Corneal Abrasion
|
0.00%
0/31
|
0.00%
0/30
|
0.00%
0/31
|
3.3%
1/30 • Number of events 1
|
|
Nervous system disorders
Dysgeusia
|
6.5%
2/31 • Number of events 2
|
10.0%
3/30 • Number of events 3
|
22.6%
7/31 • Number of events 7
|
26.7%
8/30 • Number of events 8
|
|
Nervous system disorders
Headache
|
0.00%
0/31
|
0.00%
0/30
|
0.00%
0/31
|
3.3%
1/30 • Number of events 1
|
|
Nervous system disorders
Sinus Headache
|
0.00%
0/31
|
0.00%
0/30
|
3.2%
1/31 • Number of events 1
|
0.00%
0/30
|
|
Endocrine disorders
Hypothyroidism
|
3.2%
1/31 • Number of events 1
|
0.00%
0/30
|
0.00%
0/31
|
0.00%
0/30
|
|
General disorders
Fatigue
|
0.00%
0/31
|
0.00%
0/30
|
3.2%
1/31 • Number of events 1
|
0.00%
0/30
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/31
|
3.3%
1/30 • Number of events 1
|
0.00%
0/31
|
0.00%
0/30
|
|
Respiratory, thoracic and mediastinal disorders
Throat Irritation
|
0.00%
0/31
|
0.00%
0/30
|
0.00%
0/31
|
3.3%
1/30 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/31
|
0.00%
0/30
|
0.00%
0/31
|
3.3%
1/30 • Number of events 1
|
|
Eye disorders
Eyelid Oedema
|
3.2%
1/31
|
0.00%
0/30
|
0.00%
0/31
|
0.00%
0/30
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER