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An Open-Label Extension of a Phase 3 Study of OTX-101 in the Treatment of Keratoconjunctivitis Sicca

An Open-Label Extension of a Randomized, Multicenter, Double-Masked, Vehicle-Controlled Study of the Safety and Efficacy of OTX-101 in the Treatment of Keratoconjunctivitis Sicca

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02845674
Enrollment
258
Registered
2016-07-27
Start date
2016-07-29
Completion date
2017-08-15
Last updated
2021-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Keratoconjunctivitis Sicca

Brief summary

This is a safety extension enrolling subjects participating in Study OTX-101-2016-001 (NCT02688556)

Interventions

DRUGOTX-101 0.09%

0.09% cyclosporine nanomicellar solution

Sponsors

Sun Pharmaceutical Industries Limited
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Completion of Study OTX-101-2016-001

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frameDescription
Adverse Events40 weeksNumber of subjects reporting any AEs

Participant flow

Pre-assignment details

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.

Participants by arm

ArmCount
Group 1
0.09% cyclosporine nanomicellar solution OTX-101 0.09%: 0.09% cyclosporine nanomicellar solution
129
Group 2
OTX-101 0.09%: 0.09% cyclosporine nanomicellar solution
129
Total258

Baseline characteristics

CharacteristicGroup 2TotalGroup 1
Age, Continuous61.5 years
STANDARD_DEVIATION 14.21
60.0 years
STANDARD_DEVIATION 14.92
58.4 years
STANDARD_DEVIATION 15.51
Ethnicity (NIH/OMB)
Hispanic or Latino
8 Participants26 Participants18 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
121 Participants232 Participants111 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Asian
3 Participants6 Participants3 Participants
Race (NIH/OMB)
Black or African American
13 Participants25 Participants12 Participants
Race (NIH/OMB)
More than one race
2 Participants4 Participants2 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
1 Participants1 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
110 Participants221 Participants111 Participants
Sex: Female, Male
Female
107 Participants216 Participants109 Participants
Sex: Female, Male
Male
22 Participants42 Participants20 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 1290 / 129
other
Total, other adverse events
55 / 12969 / 129
serious
Total, serious adverse events
4 / 1294 / 129

Outcome results

Primary

Adverse Events

Number of subjects reporting any AEs

Time frame: 40 weeks

Population: 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.

ArmMeasureValue (NUMBER)
Group 1Adverse Events68 Count of participants
Group 2Adverse Events81 Count of participants

Source: ClinicalTrials.gov · Data processed: Feb 16, 2026