Keratoconjunctivitis SiccaPhase 3NCT02845674

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

A Phase 3 study testing OTX-101 0.09% in people with Keratoconjunctivitis Sicca, run by Sun Pharmaceutical Industries Limited.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a safety extension enrolling subjects participating in Study OTX-101-2016-001 (NCT02688556) Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Keratoconjunctivitis Sicca
What is being tested?: OTX-101 0.09%
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 258 participants
Where: No sites listed yet
Study dates: 29 Jul 2016to 15 Aug 2017
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Completion of Study OTX-101-2016-001

Who cannot join

About this study

Official title: 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

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

Conditions: Keratoconjunctivitis Sicca
Being tested: OTX-101 0.09%
Medical subject headings: Keratoconjunctivitis Sicca

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OTX-101 0.09%Drug
Also called Seciera
0.09% cyclosporine nanomicellar solution

Study groups in NCT02845674
Study group	Role	What they receive
OTX-101 0.09%	Experimental	0.09% cyclosporine nanomicellar solution Receives: Drug: OTX-101 0.09%

What is being measured

The primary outcome is the main question the study is designed to answer.

Adverse Events
Number of subjects reporting any AEs
Measured: 40 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Jul 201615 Aug 2017

First posted27 Jul 2016 (estimated)
Study start29 Jul 2016
Primary completion15 Aug 2017
Study completion15 Aug 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Keratoconjunctivitis SiccaStudies of the same condition, open and under way.
More trials run by Sun Pharmaceutical Industries LimitedThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 258 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02845674
Sponsor's protocol ID: OTX-101-2016-002
Status last verified: Nov 2021
First submitted: 24 Jul 2016
Last updated: 19 Nov 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Sheppard J, Bergmann M, Schechter BA, Luchs J, Ogundele A, Karpecki P. Phase 3 Efficacy (Worse-Eye Analysis) and Long-Term Safety Evaluation of OTX-101 in Patients with Keratoconjunctivitis Sicca. Clin Ophthalmol. 2021 Jan 12;15:129-140. doi: 10.2147/OPTH.S279364. eCollection 2021.
PubMed 33469259

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Keratoconjunctivitis Sicca trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT02845674
Acronym / sponsor ID: OTX-101-2016-002
Conditions: Keratoconjunctivitis Sicca
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 258 participants (actual)
Lead sponsor: Sun Pharmaceutical Industries LimitedIndustry (pharma, biotech, devices)
Study start: 29 Jul 2016 (actual)
Primary completion: 15 Aug 2017 (actual)
Study completion: 15 Aug 2017 (actual)
First posted: 27 Jul 2016 (estimated)
Results: Posted 14 Dec 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
OTX-101 0.09%	Experimental	Drug: OTX-101 0.09%0.09% cyclosporine nanomicellar solution

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Completion of Study OTX-101-2016-001

Key exclusion criteria (1 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
OTX-101 0.09%Also: Seciera0.09% cyclosporine nanomicellar solution	Drug	OTX-101 0.09%

Primary outcome

Adverse Events
Time frame: 40 weeks
Number of subjects reporting any AEs

Results and safety

Results posted to the registry on 14 Dec 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
OTX-101 0.09% to OTX-101 0.09%	129	111
Vehicle to OTX-101 0.09%	129	79

Primary outcome: Adverse Events

Time frame: 40 weeks. Number. Unit: Count of participants

Measure	Group 1 n = 129	Group 2 n = 129
Value	68	81

Population analysed: 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.

Adverse events

Time frame: Day 448. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1	4 of 129 (3.1%)	55 of 129 (42.6%)	0 of 129
Group 2	4 of 129 (3.1%)	69 of 129 (53.5%)	0 of 129

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33469259Sheppard J, Bergmann M, Schechter BA, Luchs J, Ogundele A, Karpecki P. Phase 3 Efficacy (Worse-Eye Analysis) and Long-Term Safety Evaluation of OTX-101 in Patients with Keratoconjunctivitis Sicca. Clin Ophthalmol. 2021 Jan 12;15:129-140. doi: 10.2147/OPTH.S279364. eCollection 2021.
Individual participant dataSharing planned: Undecided

Related trials for Keratoconjunctivitis Sicca

Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
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RecruitingObservational study
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RecruitingObservational study
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Not yet recruitingPhase 2
Evaluation of Allogenic Mesenchymal Stem Cell (MSC) Injection Therapy for Refractory Graft-versus-Host Disease (GVHD) Unresponsive to Conventional Treatments
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing OTX-101 0.09% in people with Keratoconjunctivitis Sicca, run by Sun Pharmaceutical Industries Limited.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Dec 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse Events (time frame: 40 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02845674, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2021.