Trial Outcomes & Findings for Study of SAF312 as an Eye Drop for Treatment of Eye Pain Following Photorefractive Keratectomy (PRK) Surgery (NCT NCT02961062)
NCT ID: NCT02961062
Last Updated: 2021-10-06
Results Overview
VAS pain severity scale pre-dose, 6 hours post-operatively. The Visual Analog Scale (VAS) is a commonly used measurement of pain, discomfort, that goes from 0 meaning no pain to 100 meaning worst imaginable pain
COMPLETED
PHASE2
40 participants
6 hours
2021-10-06
Participant Flow
A total of 40 patients were randomized in a 1:1 ratio to two treatment sequences: SAF312 followed by Vehicle, or Vehicle followed by SAF312.
Bilateral crossover design: A crossover design was utilized in order to decrease the inter-patient variability due to different pain tolerance in different individuals.
Participant milestones
| Measure |
Treatment Sequence 1
Vehicle/SAF312
|
Treatment Sequence 2
SAF312 / Vehicle
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of SAF312 as an Eye Drop for Treatment of Eye Pain Following Photorefractive Keratectomy (PRK) Surgery
Baseline characteristics by cohort
| Measure |
Treatment Sequence 1
n=20 Participants
Vehicle/SAF312
|
Treatment Sequence 2
n=20 Participants
SAF312 / Vehicle
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34.4 years
STANDARD_DEVIATION 10.77 • n=5 Participants
|
33.7 years
STANDARD_DEVIATION 8.94 • n=7 Participants
|
34.0 years
STANDARD_DEVIATION 9.78 • n=5 Participants
|
|
Sex/Gender, Customized
male
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Sex/Gender, Customized
female
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
white
|
18 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
multiple
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
non hispanic latino
|
19 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
hispanic latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 hoursPopulation: Primary PD Analysis set
VAS pain severity scale pre-dose, 6 hours post-operatively. The Visual Analog Scale (VAS) is a commonly used measurement of pain, discomfort, that goes from 0 meaning no pain to 100 meaning worst imaginable pain
Outcome measures
| Measure |
SAF312
n=40 Participants
treatment participants from both sequences
|
Vehicle
n=40 Participants
comparator participants from both sequences
|
|---|---|---|
|
Visual Analog Scale (VAS) Pre-dose Pain Assessment
|
34.63 score on a scale
Standard Error 4.05
|
45.76 score on a scale
Standard Error 4.10
|
PRIMARY outcome
Timeframe: 12 hoursPopulation: Primary PD Analysis set
VAS pain severity scale from the first post-operative assessment to pre-dose 12 hours post-operative assesment The Visual Analog Scale (VAS) is a commonly used measurement of pain, discomfort, that goes from 0 meaning no pain to 100 meaning worst imaginable pain
Outcome measures
| Measure |
SAF312
n=40 Participants
treatment participants from both sequences
|
Vehicle
n=40 Participants
comparator participants from both sequences
|
|---|---|---|
|
Average Ocular Pain VAS Assessments
|
30.90 score on a scale
Standard Error 4.07
|
39.47 score on a scale
Standard Error 4.11
|
SECONDARY outcome
Timeframe: 6,12, 24, 48 and 72 hours post-operatievlyPopulation: Secondary PD analysis set
Summary of oral rescue medication use incidence (number of patients who DID NOT use oral rescue medication)
Outcome measures
| Measure |
SAF312
n=40 Participants
treatment participants from both sequences
|
Vehicle
n=40 Participants
comparator participants from both sequences
|
|---|---|---|
|
Incidence of and Amount of Rescue Oral Analgesics (Number of Participants Who Did Not Use Oral Rescue Medication)
0-6 hours post-operatively
|
23 Participants
|
19 Participants
|
|
Incidence of and Amount of Rescue Oral Analgesics (Number of Participants Who Did Not Use Oral Rescue Medication)
0-12 hours post-operatively
|
19 Participants
|
16 Participants
|
|
Incidence of and Amount of Rescue Oral Analgesics (Number of Participants Who Did Not Use Oral Rescue Medication)
0-24 hours post-operatively
|
16 Participants
|
12 Participants
|
|
Incidence of and Amount of Rescue Oral Analgesics (Number of Participants Who Did Not Use Oral Rescue Medication)
0-48 hours post-operatively
|
11 Participants
|
11 Participants
|
|
Incidence of and Amount of Rescue Oral Analgesics (Number of Participants Who Did Not Use Oral Rescue Medication)
0-72 hours post-operatively
|
11 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: 72 hoursPopulation: Primary PD Analysis set
VAS pain assessment during the first 72 hours post-operatively. VAS pain severity scale from the first post-operative assessment to pre-dose 12 hours post-operative assesment The Visual Analog Scale (VAS) is a commonly used measurement of pain, discomfort, that goes from 0 meaning no pain to 100 meaning worst imaginable pain
Outcome measures
| Measure |
SAF312
n=40 Participants
treatment participants from both sequences
|
Vehicle
n=40 Participants
comparator participants from both sequences
|
|---|---|---|
|
VAS Pain Assessments
|
5.13 score on a scale
Standard Error 4.05
|
3.58 score on a scale
Standard Error 4.10
|
SECONDARY outcome
Timeframe: day1, day 4Population: PK Analysis set
C Max
Outcome measures
| Measure |
SAF312
n=40 Participants
treatment participants from both sequences
|
Vehicle
n=40 Participants
comparator participants from both sequences
|
|---|---|---|
|
Plasma Concentration of SAF312
day 1
|
0.454 ng/mL
Standard Deviation 0.227
|
—
|
|
Plasma Concentration of SAF312
day 4
|
2.40 ng/mL
Standard Deviation 1.53
|
—
|
Adverse Events
SAF312
Vehicle
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
SAF312
n=40 participants at risk
treatment participants from both sequences
|
Vehicle
n=40 participants at risk
Vehicle
|
|---|---|---|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/40 • approximately 15 months
|
2.5%
1/40 • approximately 15 months
|
|
Eye disorders
Corneal infiltrates
|
0.00%
0/40 • approximately 15 months
|
2.5%
1/40 • approximately 15 months
|
|
Eye disorders
Corneal opacity
|
2.5%
1/40 • approximately 15 months
|
2.5%
1/40 • approximately 15 months
|
|
Eye disorders
Punctate keratitis
|
2.5%
1/40 • approximately 15 months
|
2.5%
1/40 • approximately 15 months
|
|
Eye disorders
Vitreous detachment
|
2.5%
1/40 • approximately 15 months
|
0.00%
0/40 • approximately 15 months
|
|
Gastrointestinal disorders
Vomiting
|
2.5%
1/40 • approximately 15 months
|
0.00%
0/40 • approximately 15 months
|
|
General disorders
Pyrexia
|
2.5%
1/40 • approximately 15 months
|
0.00%
0/40 • approximately 15 months
|
|
Infections and infestations
Nasopharyngitis
|
5.0%
2/40 • approximately 15 months
|
0.00%
0/40 • approximately 15 months
|
|
Infections and infestations
Sinusitis
|
2.5%
1/40 • approximately 15 months
|
0.00%
0/40 • approximately 15 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.5%
1/40 • approximately 15 months
|
0.00%
0/40 • approximately 15 months
|
|
Nervous system disorders
Headache
|
2.5%
1/40 • approximately 15 months
|
2.5%
1/40 • approximately 15 months
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.5%
1/40 • approximately 15 months
|
0.00%
0/40 • approximately 15 months
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
2.5%
1/40 • approximately 15 months
|
0.00%
0/40 • approximately 15 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER