Dry EyePhase 4NCT04835623
CEQUA for Sjogren's Syndrome Dry Eye
A Phase 4 study testing Cyclosporine 0.09% Ophthalmic Solution in people with Dry Eye and Dry Eye Syndromes, run by Center for Ophthalmic and Vision Research, LLC at 1 site in United States.
Trial summary
The primary objective of this study is to show that CEQUA (cyclosporine 0.09% ophthalmic solution) improves symptoms of dry eye disease in a population of patients with Sjogren's Syndrome diagnosis. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Dry Eye, Dry Eye Syndromes, Sjogren's Syndrome
- What is being tested?
- Cyclosporine 0.09% Ophthalmic Solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jun 2021to 21 Mar 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of Sjogren's Syndrome.
- Self-reported complaints of ocular dryness for a period of at least 3 months
- Best-corrected distance visual acuity of 20/25 or better in each eye.
Who cannot join
- Use of cyclosporine within the last 3 months.
- Use of ocular steroid within the 3 months.
- Previous history of treatment failure with cyclosporine.
- Known hypersensitivity or contraindication to the study medication or any of its ingredients.
- Use of any systemic or topical ocular medication that is known to cause or exacerbate dry eye.
- Any active ocular infection.
Show all 9Show fewer
- Severe or serious ocular condition in either eye or any other unstable medical condition that may preclude study treatment or follow-up.
- History or presence of chronic generalized systemic disease that might increase the risk to the subject or confound the results of the study.
- Currently pregnant or lactating.
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Ophthalmic and Vision Recearch
Manhattan, New York, 10022
About this study
Official title: Effects of CEQUA™ on Objective and Subjective Dry Eye Findings Associated With Sjogren's Syndrome
The primary objective of this study is to show that CEQUA (cyclosporine 0.09% ophthalmic solution) improves symptoms of dry eye disease in a population of patients with Sjogren's Syndrome diagnosis.
Read the detailed description
After being informed about the study and potential risks, all participants giving informed consent will have an eye exam and will be asked about their medical history to determine eligibility for the study. Eligible participants will continue to the second visit the same day or up to 10 days later. During the second visit participants will answer questionnaires about their eyes and have their vision, eyes, and tears examined. All participants will be given CEQUA to use over the duration of the study. The same procedures will be repeated every four weeks for 3 months total.
- Conditions
- Dry Eye, Dry Eye Syndromes, Sjogren's Syndrome
- Being tested
- Cyclosporine 0.09% Ophthalmic Solution
- Medical subject headings
- Dry Eye Syndromes, Sjogren's Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cyclosporine 0.09% Ophthalmic SolutionDrug
Also called Cequa Ophthalmic Product
one drop each eye twice daily
| Study group | Role | What they receive |
|---|---|---|
| Cyclosporine | Experimental | Participants receive Cyclosporine 0.09% Ophthalmic Solution (Cequa), 1 drop, each eye, twice a day for 12 weeks Receives: Drug: Cyclosporine 0.09% Ophthalmic Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from baseline in total corneal staining
Expanded NEI corneal staining scale ranging from 0 to 15
Measured: Baseline and week 12
Secondary outcomes (2)
Mean change from baseline in total conjunctival staining
Expanded NEI conjunctival staining scale ranging from 0 to 20
Measured: Baseline and week 12
Mean change from baseline in the score of dry eye questionnaires
Dry eye questionnaire score ranging from 0 to 28
Measured: Baseline and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start21 Jun 2021
- Primary completion21 Mar 2024
- Study completion21 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies of the same condition, open and under way.
- 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center for Ophthalmic and Vision Research, LLC
- Sponsor type
- University, hospital or other
- Collaborators
- Sun Pharmaceutical Industries Limited
- Responsible party
- Sponsor
- Investigators
- John Rocco Robilotto, OD, PhD, Principal investigator, Center for Ophthalmic and Vision Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04835623
- Sponsor's protocol ID
- SP-001
- Status last verified
- Apr 2024
- First submitted
- 5 Apr 2021
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of CEQUA™ on Objective and Subjective Dry Eye Findings Associated With Sjogren's Syndrome
- ClinicalTrials.gov ID
- NCT04835623
- Acronym / sponsor ID
- SP-001
- Conditions
- Dry Eye, Dry Eye Syndromes, Sjogren's Syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Center for Ophthalmic and Vision Research, LLCUniversity, hospital or other
- Collaborators
- Sun Pharmaceutical Industries Limited
- Study start
- 21 Jun 2021 (actual)
- Primary completion
- 21 Mar 2024 (actual)
- Study completion
- 21 Mar 2024 (actual)
- First posted
- 8 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to show that CEQUA (cyclosporine 0.09% ophthalmic solution) improves symptoms of dry eye disease in a population of patients with Sjogren's Syndrome diagnosis.
Detailed description
After being informed about the study and potential risks, all participants giving informed consent will have an eye exam and will be asked about their medical history to determine eligibility for the study. Eligible participants will continue to the second visit the same day or up to 10 days later. During the second visit participants will answer questionnaires about their eyes and have their vision, eyes, and tears examined. All participants will be given CEQUA to use over the duration of the study. The same procedures will be repeated every four weeks for 3 months total.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cyclosporine | Experimental | Drug: Cyclosporine 0.09% Ophthalmic SolutionParticipants receive Cyclosporine 0.09% Ophthalmic Solution (Cequa), 1 drop, each eye, twice a day for 12 weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of Sjogren's Syndrome.
- Self-reported complaints of ocular dryness for a period of at least 3 months
- Best-corrected distance visual acuity of 20/25 or better in each eye.
Key exclusion criteria (9 listed)
- Use of cyclosporine within the last 3 months.
- Use of ocular steroid within the 3 months.
- Previous history of treatment failure with cyclosporine.
- Known hypersensitivity or contraindication to the study medication or any of its ingredients.
- Use of any systemic or topical ocular medication that is known to cause or exacerbate 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 |
|---|---|---|
| Cyclosporine 0.09% Ophthalmic SolutionAlso: Cequa Ophthalmic Productone drop each eye twice daily | Drug | Cyclosporine |
Primary outcome
Mean change from baseline in total corneal staining
Time frame: Baseline and week 12
Expanded NEI corneal staining scale ranging from 0 to 15
2 secondary outcomes
Mean change from baseline in total conjunctival staining
Time frame: Baseline and week 12
Mean change from baseline in the score of dry eye questionnaires
Time frame: Baseline and week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
- Individual participant dataSharing planned: No
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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.
John Rocco Robilotto, OD, PhD principal investigator
Center for Ophthalmic and Vision Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cyclosporine 0.09% Ophthalmic Solution in people with Dry Eye and Dry Eye Syndromes, run by Center for Ophthalmic and Vision Research, LLC at 1 site 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 3 inclusion and 9 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 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 from baseline in total corneal staining (time frame: Baseline and week 12). 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 16 Apr 2024.