A Phase 3 interventional study of OTX-101 0.09% in Keratoconjunctivitis Sicca, sponsored by Sun Pharmaceutical Industries Limited. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-11-19.
Sponsored by Sun Pharmaceutical Industries Limited · Phase 3, Interventional, and Treatment
This is a safety extension enrolling subjects participating in Study OTX-101-2016-001 (NCT02688556)
85 studies on the registry are indexed under Keratoconjunctivitis Sicca; 1 is open to participants now.
This study's enrollment of 258 is above the median of 82 across 75 interventional studies indexed under Keratoconjunctivitis Sicca.
Browse Keratoconjunctivitis Sicca studies →Sun Pharmaceutical Industries Limited is the lead sponsor of 60 studies on the registry; 5 are open to participants now.
Of its 24 completed or terminated interventional studies of FDA-regulated products, 22 (92%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
-
0.09% cyclosporine nanomicellar solution
Drug: OTX-101 0.09%
0.09% cyclosporine nanomicellar solution
Also known as: Seciera
Adverse Events
Number of subjects reporting any AEs
Time frame: 40 weeks
| Milestone | OTX-101 0.09% to OTX-101 0.09% | Vehicle to OTX-101 0.09% |
|---|---|---|
| Started | 129 | 129 |
| Completed | 111 | 79 |
| Not completed | 18 | 50 |
Number of subjects reporting any AEs
| Count of participants | Group 1 | Group 2 |
|---|---|---|
| Adverse Events | 68 | 81 |
Collected over Day 448. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group 1 | 0/129 (0%) | 4/129 (3.1%) | 55/129 (42.6%) |
| Group 2 | 0/129 (0%) | 4/129 (3.1%) | 69/129 (53.5%) |
| Event | Group 1 | Group 2 |
|---|---|---|
| OsteoarthritisMusculoskeletal and connective tissue disorders | 2/129 | 1/129 |
| Cerebrovascular accidentNervous system disorders | 0/129 | 2/129 |
| Wound dehiscenceInjury, poisoning and procedural complications | 1/129 | 0/129 |
| DehydrationMetabolism and nutrition disorders | 1/129 | 0/129 |
| OsteoarthritisMusculoskeletal and connective tissue disorders | 0/129 | 1/129 |
| Femur fractureInjury, poisoning and procedural complications | 0/129 | 1/129 |
| Event | Group 1 | Group 2 |
|---|---|---|
| Instillation site painGeneral disorders | 17/129 | 42/129 |
| Conjunctival hyperaemiaEye disorders | 12/129 | 14/129 |
| Punctate keratitisEye disorders | 12/129 | 4/129 |
| Vitreous detachmentEye disorders | 5/129 | 2/129 |
| Posterior capsule opacificationEye disorders | 5/129 | 1/129 |
| BlepharitisEye disorders | 3/129 | 4/129 |
| Instillation site reactionGeneral disorders | 1/129 | 3/129 |
| Instillation site lacrimationGeneral disorders | 1/129 | 3/129 |
| Atrial fibrillationCardiac disorders | 2/129 | 0/129 |
| Eye irritationEye disorders | 2/129 | 2/129 |
Intent to treat 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
| Age, Continuous(years) | Group 1 | Group 2 | Total |
|---|---|---|---|
| Mean | 58.4 ± 15.51 | 61.5 ± 14.21 | 60.0 ± 14.92 |
| Sex: Female, Male(Participants) | Group 1 | Group 2 | Total |
|---|---|---|---|
| Female | 109 | 107 | 216 |
| Male | 20 | 22 | 42 |
| Ethnicity (NIH/OMB)(Participants) | Group 1 | Group 2 | Total |
|---|---|---|---|
| Hispanic or Latino | 18 | 8 | 26 |
| Not Hispanic or Latino | 111 | 121 | 232 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Group 1 | Group 2 | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 |
| Asian | 3 | 3 | 6 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 1 |
| Black or African American | 12 | 13 | 25 |
| White | 111 | 110 | 221 |
| More than one race | 2 | 2 | 4 |
| Unknown or Not Reported | 0 | 0 | 0 |
No study locations are listed for this record.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
Ran from Jul 2016 to primary completion in Aug 2017, 12 months.
Results were first posted in Dec 2018, 1 year 3 months after primary completion.
Of 12 phase 3 interventional studies under Keratoconjunctivitis Sicca, half reached primary completion within 14 months of starting (the median); a quarter within 7 and three quarters within 18. This study's 12 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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