Keratoconjunctivitis SiccaPhase 3EmeraldNCT02688556
Phase 3 Study of OTX-101 in the Treatment of Keratoconjunctivitis Sicca
A Phase 3 study testing cyclosporine in people with Keratoconjunctivitis Sicca, run by Sun Pharmaceutical Industries Limited at 3 sites in United States.
Trial summary
This is a randomized, double-masked, vehicle-controlled study of the safety and efficacy of OTX-101 (0.09% cyclosporine nanomicellar solution) in the treatment of keratoconjunctivitis sicca to be conducted at approximately 50 sites. 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?
- cyclosporine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 745 participants
- Where
- 3 sitesUnited States
- Study dates
- Feb 2016to Dec 2016
- 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
- History of dry eye syndrome (KCS) for a period of at least 6 months
- Clinical diagnosis of bilateral KCS
- Lissamine green conjunctival staining sum score of ≥ 3 to ≤ 9 out of a total possible score of 12 (scoring excludes superior zones 2 and 4) in the same eye at both the Screening and Baseline Visits.
- Global symptom score (SANDE) ≥ 40 mm at both the Screening and Baseline Visits
- Corrected Snellen visual acuity (VA) of better than 20/200 in each eye.
Who cannot join
- Use of cyclosporine ophthalmic emulsion 0.05% (Restasis®) within 3 months prior to the Screening Visit.
- Previous treatment failure (lack of efficacy) with cyclosporine ophthalmic emulsion 0.05% (Restasis).
- Diagnosis of Sjögren's disease ˃ 5 years prior to the Screening Visit.
- Clinical diagnosis or any history of seasonal and/or perennial allergic conjunctivitis.
- Use of systemic or topical medications within 7 days prior to the Screening Visit or during the study period that are known to cause dry eye.
- Use of any topical ophthalmic medications, prescription (including anti-glaucoma medications) or over the counter (including artificial tears), other than the assigned study medication during the study period.
Show all 11Show fewer
- Current active eye disease other than dry wyw syndrome (i.e., any disease for which topical or systemic ophthalmic medication is necessary).
- History of herpes keratitis.
- Corneal transplant
- Corneal refractive surgery within 6 months prior to the Screening Visit or postoperative refractive surgery symptoms of dryness that have not resolved.
- Cataract surgery within 3 months prior to the Screening Visit.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Cincinnati Eye Institute
Edgewood, Kentucky, 41017
Fifth Avenue Eye Associates
New York, New York, 10028
Martel Eye Medical Group
Rancho Cordova, California, 95670
About this study
Official title: 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 randomized, double-masked, vehicle-controlled study of the safety and efficacy of OTX-101 (0.09% cyclosporine nanomicellar solution) in the treatment of keratoconjunctivitis sicca to be conducted at approximately 50 sites.
- Conditions
- Keratoconjunctivitis Sicca
- Being tested
- cyclosporine, vehicle of OTX-101
- Keywords
- KCS, dry eye, cyclosporine
- Medical subject headings
- Keratoconjunctivitis Sicca, Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cyclosporineDrug
Also called Seciera
vehicle of OTX-101Drug
| Study group | Role | What they receive |
|---|---|---|
| OTX-101 0.09% | Experimental | 0.09% cyclosporine nanomicellar ophthalmic solution Receives: Drug: cyclosporine |
| Vehicle | Placebo comparator | vehicle of OTX-101 Receives: Drug: vehicle of OTX-101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tear Production
Percentage of Eyes with Increase from Baseline of ≥ 10 mm in Schirmer's Test Score
Measured: Baseline and 12 weeks
Secondary outcomes (3)
Conjunctival Staining
change from baseline in total conjunctival staining score (lissamine green, modified National Eye Institute scale) at 12 weeks.
Conjunctival Lissamine Green Staining Grades ranged from 0 (No punctate stain in zone) to 3 (Densely concentrated micropunctate stain spots)
Measured: Baseline and 12 weeks
Central Corneal Staining
change from baseline in central corneal staining score (fluorescein, modified NEI/FDA scale) at 12 weeks.
The Expanded National Eye Institute (NEI)/Industry Workshop Scale for Corneal Staining Score was used to grade each of the 5 areas of the cornea on a 0 (No punctate stain in area) to 4 (Severe diffuse (coalescent) macropunctate stain of the area) scale.
Measured: Baseline and 12 weeks
Symptom Score
change from baseline in modified Symptom Assessment in Dry Eye (SANDE) score at 12 weeks.
A modified SANDE instrument was used to evaluate dry eye symptoms at each visit.
Subjects were asked to indicate:
- frequency of dry and irritated eyes on a scale of 0 (rarely) to 100 (all the time); and
- severity of dry eyes on a scale of 0 (very mild) to 100 (severe) The global symptom score is the square root of the frequency score times the severity score and will be completed at each visit. (range 0 to 100)
Negative change from baseline indicates improvement.
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionNov 2016
- Study completionDec 2016
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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 745 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Pharmaceutical Industries Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02688556
- Sponsor's protocol ID
- OTX-101-2016-001
- Acronym
- Emerald
- Status last verified
- Nov 2021
- First submitted
- 13 Feb 2016
- Last updated
- 29 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- NCT02688556
- Acronym / sponsor ID
- Emerald / OTX-101-2016-001
- Conditions
- Keratoconjunctivitis Sicca
- Keywords
- KCS, dry eye, cyclosporine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 745 participants (actual)
- Lead sponsor
- Sun Pharmaceutical Industries LimitedIndustry (pharma, biotech, devices)
- Study start
- Feb 2016 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 23 Feb 2016 (estimated)
- Results
- Posted 8 Apr 2019
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 randomized, double-masked, vehicle-controlled study of the safety and efficacy of OTX-101 (0.09% cyclosporine nanomicellar solution) in the treatment of keratoconjunctivitis sicca to be conducted at approximately 50 sites.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OTX-101 0.09% | Experimental | Drug: cyclosporine0.09% cyclosporine nanomicellar ophthalmic solution |
| Vehicle | Placebo comparator | Drug: vehicle of OTX-101vehicle of OTX-101 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- History of dry eye syndrome (KCS) for a period of at least 6 months
- Clinical diagnosis of bilateral KCS
- Lissamine green conjunctival staining sum score of ≥ 3 to ≤ 9 out of a total possible score of 12 (scoring excludes superior zones 2 and 4) in the same eye at both the Screening and Baseline Visits.
- Global symptom score (SANDE) ≥ 40 mm at both the Screening and Baseline Visits
- Corrected Snellen visual acuity (VA) of better than 20/200 in each eye.
Key exclusion criteria (11 listed)
- Use of cyclosporine ophthalmic emulsion 0.05% (Restasis®) within 3 months prior to the Screening Visit.
- Previous treatment failure (lack of efficacy) with cyclosporine ophthalmic emulsion 0.05% (Restasis).
- Diagnosis of Sjögren's disease ˃ 5 years prior to the Screening Visit.
- Clinical diagnosis or any history of seasonal and/or perennial allergic conjunctivitis.
- Use of systemic or topical medications within 7 days prior to the Screening Visit or during the study period that are known to cause dry eye.
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 |
|---|---|---|
| cyclosporineAlso: Seciera | Drug | OTX-101 0.09% |
| vehicle of OTX-101 | Drug | Vehicle |
Primary outcome
Tear Production
Time frame: Baseline and 12 weeks
Percentage of Eyes with Increase from Baseline of ≥ 10 mm in Schirmer's Test Score
3 secondary outcomes
Conjunctival Staining
Time frame: Baseline and 12 weeks
Central Corneal Staining
Time frame: Baseline and 12 weeks
Symptom Score
Time frame: Baseline and 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing cyclosporine in people with Keratoconjunctivitis Sicca, run by Sun Pharmaceutical Industries Limited at 3 sites in United States.
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 5 inclusion and 11 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 29 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 8 Apr 2019). 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?
Tear Production (time frame: Baseline and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Aug 2022.