Dry Eye DiseaseNCT05957211
Improving Drop Instillation Comfort of a Cyclosporine A Solution
A study testing 0.09% cyclosporine A ophthalmic solution in people with Dry Eye Disease, run by University of Waterloo at 1 site in Canada.
Trial summary
Patients who suffer from dry eye disease are often prescribed eye drops containing cyclosporine A that help with reducing inflammation. The newest eye drop containing cyclosporine A is called Cequa (Sun Pharma, Canada). 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?
- 0.09% cyclosporine A ophthalmic solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 19 May 2023to 20 Feb 2024
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 18 years of age.
- Ocular Surface Disease Index score >= 23.
- Strip meniscometry < 5 mm.
Who cannot join
- Contact lens wearers.
- Have corneal neuropathic or neurotrophic disease.
- Have an ocular or medical condition or taking medications that could confound a study outcome.
- Currently pregnant or breastfeeding (cyclosporine is a FDA pregnancy Category C drug).
- Have an ocular or medical condition for which Cequa is contraindicated (e.g., allergy to cyclosporine or other ingredients in Cequacurrent eye infection, cancer or precancerous condition in or around the eyes).
- Have an allergy to fluorescein.
Trial locations and contacts
1 site in 1 country.
About this study
Patients who suffer from dry eye disease are often prescribed eye drops containing cyclosporine A that help with reducing inflammation. The newest eye drop containing cyclosporine A is called Cequa (Sun Pharma, Canada). Unfortunately, nearly a quarter of (24.2%) of patients using Cequa have reported some form of discomfort (burning and stinging) when instilling the drops. This potentially discourages patients from continuing the eye drop, which prevents their dry eye disease from being managed effectively. This study is trying to determine if refrigerating the eye drops would allow the drops to feel more comfortable when they are instilled in the eye.
- Conditions
- Dry Eye Disease
- Being tested
- 0.09% cyclosporine A ophthalmic solution
- Keywords
- dry eye disease, cyclosporine, eye drop
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.09% cyclosporine A ophthalmic solutionDrug
Also called Cequa
Cequa is an ophthalmic solution used to treat moderate to severe dry eye disease. The typical dosage is one drop in each eye, twice a day. The drug is packaged in sterile, single use bottles.
| Study group | Role | What they receive |
|---|---|---|
| All participants | Experimental | All participants will have a refrigerated 0.09% cyclosporine drop instilled in one eye, and a non-refrigerated 0.09% cyclosporine drop instilled in the other eye. The eye that receives the refrigerated drop is randomly determined. Receives: Drug: 0.09% cyclosporine A ophthalmic solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular discomfort score. A subjective questionnaire that queries participants' ocular discomfort. The instrument ranges from 0 (no discomfort) to 10 (maximum discomfort).
Difference in ocular discomfort between the eye that receives a refrigerated Cequa drop and the eye that receives a non-refrigerated (room temperature) drop.
Measured: Within 10 minutes of drop instillation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2023
- Study start19 May 2023
- Primary completion20 Feb 2024
- Study completion20 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye DiseaseStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Waterloo
- Sponsor type
- University, hospital or other
- Collaborators
- Sun Pharmaceutical Industries Limited
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05957211
- Sponsor's protocol ID
- 45135
- Status last verified
- Aug 2024
- First submitted
- 15 Jun 2023
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Drop Instillation Comfort of a Cyclosporine A Solution
- ClinicalTrials.gov ID
- NCT05957211
- Acronym / sponsor ID
- 45135
- Conditions
- Dry Eye Disease
- Keywords
- dry eye disease, cyclosporine, eye drop
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of WaterlooUniversity, hospital or other
- Collaborators
- Sun Pharmaceutical Industries Limited
- Study start
- 19 May 2023 (actual)
- Primary completion
- 20 Feb 2024 (actual)
- Study completion
- 20 Feb 2024 (actual)
- First posted
- 24 Jul 2023 (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.
Patients who suffer from dry eye disease are often prescribed eye drops containing cyclosporine A that help with reducing inflammation. The newest eye drop containing cyclosporine A is called Cequa (Sun Pharma, Canada). Unfortunately, nearly a quarter of (24.2%) of patients using Cequa have reported some form of discomfort (burning and stinging) when instilling the drops. This potentially discourages patients from continuing the eye drop, which prevents their dry eye disease from being managed effectively. This study is trying to determine if refrigerating the eye drops would allow the drops to feel more comfortable when they are instilled in the eye.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All participants | Experimental | Drug: 0.09% cyclosporine A ophthalmic solutionAll participants will have a refrigerated 0.09% cyclosporine drop instilled in one eye, and a non-refrigerated 0.09% cyclosporine drop instilled in the other eye. The eye that receives the refrigerated drop is randomly determined. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Over 18 years of age.
- Ocular Surface Disease Index score >= 23.
- Strip meniscometry < 5 mm.
Key exclusion criteria (6 listed)
- Contact lens wearers.
- Have corneal neuropathic or neurotrophic disease.
- Have an ocular or medical condition or taking medications that could confound a study outcome.
- Currently pregnant or breastfeeding (cyclosporine is a FDA pregnancy Category C drug).
- Have an ocular or medical condition for which Cequa is contraindicated (e.g., allergy to cyclosporine or other ingredients in Cequacurrent eye infection, cancer or precancerous condition in or around the eyes).
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 |
|---|---|---|
| 0.09% cyclosporine A ophthalmic solutionAlso: CequaCequa is an ophthalmic solution used to treat moderate to severe dry eye disease. The typical dosage is one drop in each eye, twice a day. The drug is packaged in sterile, single use bottles. | Drug | All participants |
Primary outcome
Ocular discomfort score. A subjective questionnaire that queries participants' ocular discomfort. The instrument ranges from 0 (no discomfort) to 10 (maximum discomfort).
Time frame: Within 10 minutes of drop instillation
Difference in ocular discomfort between the eye that receives a refrigerated Cequa drop and the eye that receives a non-refrigerated (room temperature) drop.
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 9 Aug 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 0.09% cyclosporine A ophthalmic solution in people with Dry Eye Disease, run by University of Waterloo at 1 site in Canada.
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 6 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 9 Aug 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 Canada. 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.
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?
Ocular discomfort score. A subjective questionnaire that queries participants' ocular discomfort. The instrument ranges from 0 (no discomfort) to 10 (maximum discomfort). (time frame: Within 10 minutes of drop instillation). 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 9 Aug 2024.