Dry Eye DiseasePhase 4NCT04357795
Effect of Cequa™ in Subjects With Dry Eye Disease
A Phase 4 study testing CequaTM (Cyclosporine 0.09%) ophthalmic solution in people with Dry Eye Disease, run by Sun Pharmaceutical Industries Limited at 5 sites in United States.
Trial summary
This is a Phase 4, multicenter, single arm, 12 week study in subjects with dry eye disease, which is inadequately controlled by cyclosporine 0.05% ophthalmic emulsion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Disease
- What is being tested?
- CequaTM (Cyclosporine 0.09%) ophthalmic solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 5 sitesUnited States
- Study dates
- 29 Jun 2020to 24 Jun 2022
- Phase
- Phase 4
- 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
- Male or female subjects with a history of bilateral dry eye disease for a period of at least 3 months.
- Aged of at least 18 years.
- Subjects with total corneal fluorescein staining ≥6 or corneal fluorescein staining in an individual zone ≥2 as per National Eye Institute Grading Scale.
- Subjects with modified symptom assessment in dry eye global symptom score, ≥40 using visual analogue scale.
- Subjects with best-corrected visual acuity 20/200 or better in both eyes at the Screening/Baseline visit
Who cannot join
- Subjects who have used cyclosporin 0.05% ophthalmic emulsion in both eyes for less than 3 months prior to the Screening/Baseline visit.
- Subjects with history of treatment failure with cyclosporin 0.05% ophthalmic emulsion.
- Subjects who have active seasonal and/or perennial allergic conjunctivitis in either eye.
- Subjects who had already Use initiated any systemic or topical ocular medication.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Eye Associates of Fort Myers, 4225 Evans Ave.
Fort Myers, Florida, 33901
Texas Eye and Laser Center, 1872 Norwood Dr. #200
Hurst, Texas, 76054
Bowden Eye and Associates, 7205 Bonneval Road
Jacksonville, Florida, 32256
Eye Center of N Florida, 2500 Martin Luther King Jr Blvd
Panama City, Florida, 32405
Kannarr Eye Care, 2521 N Broadway
Pittsburg, Kansas, 66762
About this study
Official title: Effect of Cequa™ in Subjects With Dry Eye Disease That Is Currently Inadequately Controlled While on Cyclosporine 0.05% Ophthalmic Emulsion
This is a Phase 4, multicenter, single arm, 12 week study in subjects with dry eye disease, which is inadequately controlled by cyclosporine 0.05% ophthalmic emulsion.
Read the detailed description
This is a phase 4, multicenter, open-label, single-arm, 12-week study of subjects with dry eye disease that is inadequately controlled by cyclosporine (CsA) 0.05% ophthalmic emulsion. Subject enrollment will be classified by evidence of dry eye disease (ie, signs, symptoms, or both signs and symptoms). Treatment will be one drop of CsA 0.09% ophthalmic solution (Cequa) in each eye twice daily (BID) for 12 weeks. The study hypothesis is that CsA 0.09% ophthalmic solution will show improved clinical benefit in subjects whose dry eye signs and/or symptoms are inadequately controlled while on CsA.
- Conditions
- Dry Eye Disease
- Being tested
- CequaTM (Cyclosporine 0.09%) ophthalmic solution
- Keywords
- Keratoconjunctivitis Sicca, KCS, Dry eye
- Medical subject headings
- Dry Eye Syndromes, Keratoconjunctivitis Sicca
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CequaTM (Cyclosporine 0.09%) ophthalmic solutionDrug
One drop CequaTM (Cyclosporine 0.09%) ophthalmic solution in each eye twice daily, approximately 12 hours apart.
| Study group | Role | What they receive |
|---|---|---|
| CequaTM (Cyclosporine 0.09%) ophthalmic solution | Experimental | Not described Receives: Drug: CequaTM (Cyclosporine 0.09%) ophthalmic solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in Baseline in Total Corneal Fluoroscein Staining Score
Scale for Corneal Staining as defined by the FDA/NEI: 0-4 (0-no staining, 4-severe staining). The higher number indicates more severe. The lower the number indicates less severe staining on the cornea
Measured: Week12
Change From Baseline in Modified Dry Eye Scoring.
Based on questionnaire asked to subjects (sign and symptoms), modified symptom of dry eye score (range 0 to 100) will be assessed. Increase in score will indicate severity in the symptoms.
Measured: Week12
Secondary outcomes (6)
Mean Change in Baseline for Conjunctival Staining Assessment
Based on Investigator's judgement, 6 areas of the conjunctiva will be evaluated in a low to moderate intensity.
Scale for Conjunctival Staining defined: 0-6 (0 no staining, 6-severe staining). The higher the number indicates more severe. The lower the number indicates less severe staining on the conjunctival
Measured: Week 12
Changes From Baseline in Central Corneal Staining Score
Five areas of cornea will be evaluated on a 0 to 4 scale and value from 0 (absent) to 4 (severe) to each section will be allotted based on NEI grading scale
Measured: Week 12
Mean Change in Baseline for Tear Osmolarity Score for Both Eyes
Tear osmolarity of both the eyes will be assessed and score (mOsm/L) will be allotted to each eye. Higher score will indicate severity of the disease (dry eye).
Tear osmolarity OU was assessed using the TearLab Osmolarity System Test by collecting nanoliter volumes of tear fluid at each visit from each eyelid margin using the Osmolarity Test Pen and Test Card. Results were interpreted according to the provided instructions and scores (mOsm/L) for each eye were recorded. Normal, mild/moderate, and severe dry eyes had average tear osmolarity values of approximately 302+/-8 mOsm/L, 315+/-10 mOsm/L and 336+/022 mOsm/L, respectively.
Measured: Week 12
Mean Change From Baseline in Frequency of Artificial Tear Product Use.
Based on entries in the subject diaries, frequency of artificial tear product use will be assessed.
Frequency for artificial tear: This is number of times per day recorded in a daily diary log assessed at baseline and week 12. The higher the number the worse the outcome. The lower the number the better the outcome
Measured: Week 12
Schirmer's Test Score
An unanesthetized Schirmer's test was performed in each eye at least 5 minutes after the lissamine green conjunctival staining to allow for any reflex tearing to subside. At each visit, strips were placed OU at the same time and timed for 5 min. Strips were removed after 5 min and the amount of wetting was recorded in mm and also marked with a line on the strip. The Investigator recorded a score for each eye. A score of greater than 10 mm in 5 minutes is accepted as normal. A score of less than 5 mm in 5 minutes indicates a tear deficiency. A score less than 10 mm in 5 minutes indicates a change from normal in tear production.
Measured: Week 12
Percentage of Subjects Who Prefer Study Treatments Over Prior Treatment.
Subjects will be asked, which treatment they prefer for the management of the dry eye (prior treatment or study treatment).
Note- For this outcome measure, participants were provided the option to not choose either treatment as the preferred treatment.
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2020
- Study start29 Jun 2020
- Primary completion24 Jun 2022
- Study completion24 Jun 2022
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 Dry Eye DiseaseStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 135 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
- NCT04357795
- Sponsor's protocol ID
- OTX101-2019-001
- Status last verified
- Oct 2023
- First submitted
- 8 Apr 2020
- Last updated
- 6 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cequa™ in Subjects With Dry Eye Disease That Is Currently Inadequately Controlled While on Cyclosporine 0.05% Ophthalmic Emulsion
- ClinicalTrials.gov ID
- NCT04357795
- Acronym / sponsor ID
- OTX101-2019-001
- Conditions
- Dry Eye Disease
- Keywords
- Keratoconjunctivitis Sicca, KCS, Dry eye
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Sun Pharmaceutical Industries LimitedIndustry (pharma, biotech, devices)
- Study start
- 29 Jun 2020 (actual)
- Primary completion
- 24 Jun 2022 (actual)
- Study completion
- 24 Jun 2022 (actual)
- First posted
- 22 Apr 2020 (actual)
- Results
- Posted 6 Feb 2024
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 Phase 4, multicenter, single arm, 12 week study in subjects with dry eye disease, which is inadequately controlled by cyclosporine 0.05% ophthalmic emulsion.
Detailed description
This is a phase 4, multicenter, open-label, single-arm, 12-week study of subjects with dry eye disease that is inadequately controlled by cyclosporine (CsA) 0.05% ophthalmic emulsion. Subject enrollment will be classified by evidence of dry eye disease (ie, signs, symptoms, or both signs and symptoms). Treatment will be one drop of CsA 0.09% ophthalmic solution (Cequa) in each eye twice daily (BID) for 12 weeks. The study hypothesis is that CsA 0.09% ophthalmic solution will show improved clinical benefit in subjects whose dry eye signs and/or symptoms are inadequately controlled while on CsA.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CequaTM (Cyclosporine 0.09%) ophthalmic solution | Experimental | Drug: CequaTM (Cyclosporine 0.09%) ophthalmic solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female subjects with a history of bilateral dry eye disease for a period of at least 3 months.
- Aged of at least 18 years.
- Subjects with total corneal fluorescein staining ≥6 or corneal fluorescein staining in an individual zone ≥2 as per National Eye Institute Grading Scale.
- Subjects with modified symptom assessment in dry eye global symptom score, ≥40 using visual analogue scale.
- Subjects with best-corrected visual acuity 20/200 or better in both eyes at the Screening/Baseline visit
Key exclusion criteria (4 listed)
- Subjects who have used cyclosporin 0.05% ophthalmic emulsion in both eyes for less than 3 months prior to the Screening/Baseline visit.
- Subjects with history of treatment failure with cyclosporin 0.05% ophthalmic emulsion.
- Subjects who have active seasonal and/or perennial allergic conjunctivitis in either eye.
- Subjects who had already Use initiated any systemic or topical ocular medication.
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 |
|---|---|---|
| CequaTM (Cyclosporine 0.09%) ophthalmic solutionOne drop CequaTM (Cyclosporine 0.09%) ophthalmic solution in each eye twice daily, approximately 12 hours apart. | Drug | CequaTM (Cyclosporine 0.09%) ophthalmic solution |
Primary outcome
Mean Change in Baseline in Total Corneal Fluoroscein Staining Score
Time frame: Week12
Scale for Corneal Staining as defined by the FDA/NEI: 0-4 (0-no staining, 4-severe staining). The higher number indicates more severe. The lower the number indicates less severe staining on the cornea
Change From Baseline in Modified Dry Eye Scoring.
Time frame: Week12
Based on questionnaire asked to subjects (sign and symptoms), modified symptom of dry eye score (range 0 to 100) will be assessed. Increase in score will indicate severity in the symptoms.
6 secondary outcomes
Mean Change in Baseline for Conjunctival Staining Assessment
Time frame: Week 12
Changes From Baseline in Central Corneal Staining Score
Time frame: Week 12
Mean Change in Baseline for Tear Osmolarity Score for Both Eyes
Time frame: Week 12
Mean Change From Baseline in Frequency of Artificial Tear Product Use.
Time frame: Week 12
Schirmer's Test Score
Time frame: Week 12
Percentage of Subjects Who Prefer Study Treatments Over Prior Treatment.
Time frame: Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing CequaTM (Cyclosporine 0.09%) ophthalmic solution in people with Dry Eye Disease, run by Sun Pharmaceutical Industries Limited at 5 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 4 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 6 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 6 Feb 2024). 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?
Mean Change in Baseline in Total Corneal Fluoroscein Staining Score (time frame: Week12). The study lists 2 primary outcomes in all. 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 6 Feb 2024.