Trial Outcomes & Findings for An Open-Label Extension of a Phase 3 Study of OTX-101 in the Treatment of Keratoconjunctivitis Sicca (NCT NCT02845674)
NCT ID: NCT02845674
Last Updated: 2021-11-19
Results Overview
Number of subjects reporting any AEs
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
258 participants
Primary outcome timeframe
40 weeks
Results posted on
2021-11-19
Participant Flow
Group 1 and Group 2 consisted of subsets of subjects who received masked treatment with OTX-101 0.09% or with Vehicle, respectively, in OTX-101-2016-001. All subjects received open-label treatment with OTX-101 0.09% in OTX-101-2016-002.
Participant milestones
| Measure |
OTX-101 0.09% to OTX-101 0.09%
One drop in each eye BID
|
Vehicle to OTX-101 0.09%
One drop in each eye BID
|
|---|---|---|
|
Overall Study
STARTED
|
129
|
129
|
|
Overall Study
COMPLETED
|
111
|
79
|
|
Overall Study
NOT COMPLETED
|
18
|
50
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
An Open-Label Extension of a Phase 3 Study of OTX-101 in the Treatment of Keratoconjunctivitis Sicca
Baseline characteristics by cohort
| Measure |
Group 1
n=129 Participants
0.09% cyclosporine nanomicellar solution
OTX-101 0.09%: 0.09% cyclosporine nanomicellar solution
|
Group 2
n=129 Participants
OTX-101 0.09%: 0.09% cyclosporine nanomicellar solution
|
Total
n=258 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.4 years
STANDARD_DEVIATION 15.51 • n=5 Participants
|
61.5 years
STANDARD_DEVIATION 14.21 • n=7 Participants
|
60.0 years
STANDARD_DEVIATION 14.92 • n=5 Participants
|
|
Sex: Female, Male
Female
|
109 Participants
n=5 Participants
|
107 Participants
n=7 Participants
|
216 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
18 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
111 Participants
n=5 Participants
|
121 Participants
n=7 Participants
|
232 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
111 Participants
n=5 Participants
|
110 Participants
n=7 Participants
|
221 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 40 weeksPopulation: Safety population: Group 1 and Group 2 consisted of subsets of subjects who received masked treatment with OTX-101 0.09% or with Vehicle, respectively, in OTX-101-2016-001. All subjects received open-label treatment with OTX-101 0.09% in OTX-101-2016-002.
Number of subjects reporting any AEs
Outcome measures
| Measure |
Group 1
n=129 Participants
OTX-101 0.09%: 0.09% cyclosporine nanomicellar solution
|
Group 2
n=129 Participants
OTX-101 0.09%: 0.09% cyclosporine nanomicellar solution
|
|---|---|---|
|
Adverse Events
|
68 Count of participants
|
81 Count of participants
|
Adverse Events
Group 1
Serious events: 4 serious events
Other events: 55 other events
Deaths: 0 deaths
Group 2
Serious events: 4 serious events
Other events: 69 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1
n=129 participants at risk
OTX-101 0.09%: 0.09% cyclosporine nanomicellar solution
|
Group 2
n=129 participants at risk
OTX-101 0.09%: 0.09% cyclosporine nanomicellar solution
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/129 • Day 448
|
0.78%
1/129 • Number of events 2 • Day 448
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.78%
1/129 • Day 448
|
0.00%
0/129 • Day 448
|
|
Metabolism and nutrition disorders
Dehydration
|
0.78%
1/129 • Day 448
|
0.00%
0/129 • Day 448
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/129 • Day 448
|
1.6%
2/129 • Number of events 2 • Day 448
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/129 • Day 448
|
0.78%
1/129 • Day 448
|
Other adverse events
| Measure |
Group 1
n=129 participants at risk
OTX-101 0.09%: 0.09% cyclosporine nanomicellar solution
|
Group 2
n=129 participants at risk
OTX-101 0.09%: 0.09% cyclosporine nanomicellar solution
|
|---|---|---|
|
Eye disorders
Conjunctival hyperaemia
|
9.3%
12/129 • Day 448
|
10.9%
14/129 • Day 448
|
|
Eye disorders
Vitreous detachment
|
3.9%
5/129 • Day 448
|
1.6%
2/129 • Day 448
|
|
Eye disorders
Posterior capsule opacification
|
3.9%
5/129 • Day 448
|
0.78%
1/129 • Day 448
|
|
Eye disorders
Blepharitis
|
2.3%
3/129 • Day 448
|
3.1%
4/129 • Day 448
|
|
Eye disorders
Punctate keratitis
|
9.3%
12/129 • Day 448
|
3.1%
4/129 • Day 448
|
|
General disorders
Instillation site reaction
|
0.78%
1/129 • Day 448
|
2.3%
3/129 • Day 448
|
|
General disorders
Instillation site lacrimation
|
0.78%
1/129 • Day 448
|
2.3%
3/129 • Day 448
|
|
General disorders
Instillation site pruritus
|
0.00%
0/129 • Day 448
|
0.78%
1/129 • Day 448
|
|
Cardiac disorders
Atrial fibrillation
|
1.6%
2/129 • Day 448
|
0.00%
0/129 • Day 448
|
|
Eye disorders
Eye irritation
|
1.6%
2/129 • Day 448
|
1.6%
2/129 • Day 448
|
|
Eye disorders
Conjunctival haemorrhage
|
1.6%
2/129 • Day 448
|
1.6%
2/129 • Day 448
|
|
General disorders
Instillation site pain
|
13.2%
17/129 • Day 448
|
32.6%
42/129 • Day 448
|
|
Investigations
Intraocular pressure increased
|
1.6%
2/129 • Day 448
|
0.78%
1/129 • Day 448
|
|
Eye disorders
Cataract
|
1.6%
2/129 • Day 448
|
0.00%
0/129 • Day 448
|
|
Eye disorders
Cataract nuclear
|
1.6%
2/129 • Day 448
|
0.00%
0/129 • Day 448
|
|
Eye disorders
Eye allergy
|
1.6%
2/129 • Day 448
|
0.00%
0/129 • Day 448
|
|
Eye disorders
Retinal haemorrhage
|
1.6%
2/129 • Day 448
|
0.00%
0/129 • Day 448
|
|
Eye disorders
Visual acuity reduced
|
1.6%
2/129 • Day 448
|
0.00%
0/129 • Day 448
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place