Dry EyePhase 4NCT04555694
Comparing Treatment of Dry Eye With Intracanalicular Dexamethasone, Restasis, and/or Lotemax
A Phase 4 study testing Cyclosporine, Loteprednol Etabonate and Dexamethasone Ophthalmic 0.4 Mg Ophthalmic Insert in people with Dry Eye, run by Thomas Chester, OD at 1 site in United States.
Trial summary
This 6 month study seeks to compare the use of Intracanalicular Dexamethasone in conjunction with Restasis (cyclosporine ophthalmic emulsion) for the treatment of signs and symptoms of dry eye disease as compared to Restasis with Lotemax (loteprednol etabonate ophthalmic suspension 0.5%) and Restasis monotherapy. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dry Eye
- What is being tested?
- Cyclosporine, Loteprednol Etabonate and Dexamethasone Ophthalmic 0.4 Mg Ophthalmic Insert
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2020to 16 Feb 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Signs and symptoms of Dry Eye Disease
- Consent to treat with topical immunomodulator
- Willing and able to comply with clinic visits and study related procedures
- Willing and able to sign the informed consent form
Who cannot join
- Patients under the age of 18.
- Pregnancy (must be ruled out in women of child-bearing age with pregnancy test)
- Active infectious systemic disease
- Active infectious ocular or extraocular disease
- Altered nasolacrimal flow of either acquired, induced, or congenital origin
- Hypersensitivity to dexamethasone
Show all 9Show fewer
- Patients who have been on topical immunomodulating agents in the previous 3 months to their baseline visit
- Patient being treated with either topical, oral, or intravenous immunosuppressive agents, immunomodulating agents, or steroid (including NSAIDS)
- Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intracanalicular Dexamethasone Used in Conjunction With Restasis (Cyclosporine Ophthalmic Emulsion) for the Treatment of Signs and Symptoms of Dry Eye Disease as Compared to Restasis With Lotemax (Loteprednol Etabonate Ophthalmic Suspension 0.5%) and Restasis Monotherapy.
This 6 month study seeks to compare the use of Intracanalicular Dexamethasone in conjunction with Restasis (cyclosporine ophthalmic emulsion) for the treatment of signs and symptoms of dry eye disease as compared to Restasis with Lotemax (loteprednol etabonate ophthalmic suspension 0.5%) and Restasis monotherapy.
- Conditions
- Dry Eye
- Being tested
- Cyclosporine, Loteprednol Etabonate, Dexamethasone Ophthalmic 0.4 Mg Ophthalmic Insert
- 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.
CyclosporineDrug
Also called Restasis
Used to increase tear production in patients who have dry eye caused by inflammation
Loteprednol EtabonateDrug
Also called Lotemax
Used to treat inflammation of the eye
Dexamethasone Ophthalmic 0.4 Mg Ophthalmic InsertDrug
Also called Dextenza
Used to treat inflammation of the eye
| Study group | Role | What they receive |
|---|---|---|
| Restasis and Lotemax | Active comparator | 10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes and Lotemax ophthalmic solution twice a day in both eyes. Receives: Drug: Cyclosporine; Drug: Loteprednol Etabonate |
| Restasis and Dextenza | Active comparator | 10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes, as well as receiving Dextenza insertion in both lower lids. Receives: Drug: Cyclosporine; Drug: Dexamethasone Ophthalmic 0.4 Mg Ophthalmic Insert |
| Restasis | Active comparator | 10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes Receives: Drug: Cyclosporine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Ocular Surface Staining From Baseline
The primary outcome measure was the mean corneal surface staining (guided by use of fluorescein and lissamine green) at weeks 4, 8 and 12 from baseline based on the National Eye Institute grading scale.
Corneal fluorescein staining was scored from 0 to 3 on the scale (none, better to heavy, worse) in five regions of the cornea and summed for a total score of 0-15.
Measured: Baseline to Week 4, Week 8 and Week 12
Secondary outcomes (6)
Mean Conjunctival Staining
The mean conjunctival staining (guided by use of lissamine green) at weeks 4, 8 and 12 from baseline based on the National Eye Institute grading scale.
Conjunctival staining was scored from 0 to 3 on the scale (none, better to heavy, worse) in six regions of the cornea and summed for a total score of 0-18.
Measured: Baseline to Week 4, Week 8 and Week 12
Mean Schirmer Tear Test 1 Score
Schirmer Tear Test 1 score, measuring tear production, as measured by a Schirmer's test strip with anesthetic (mm/5min on a strip 0-35mm. 0 mm is worse, >15 indicates normal production) at week 4, 8 and 12 from Baseline.
Measured: Baseline to Week 4, Week 8 and Week 12
Tear Breakup Time (Seconds)
The time it takes (in seconds) for the tear film to break after blinking at Week 4, 8 and 12 from Baseline
Measured: Baseline to Week 4, Week 8 and Week 12
Tear Osmolarity
Tear osmolarity as measured by TearLab (275-307 is considered "homeostatic range") at Week 4, 8 and 12 from Baseline.
Measured: Baseline to Week 4, Week 8 and Week 12
Meibomian Gland Scores
Meibomian gland scoring on a scale of 1-4 (1 represents clear, liquid secretions and 4 is no secretions) in three regions (nasal, central, temporal) and summed for a single score between 3-12 at Week 4, 8 and 12 from baseline
Measured: Baseline to Week 4, Week 8 and Week 12
DEQ-5 Score
Dry Eye Questionnaire-5 (5 questions about dry eye symptoms rated from 0, or never to 5, or constantly) total score of 0-22 with higher scores representing worse symptoms at weeks 4, 8 and 12 from baseline
Measured: Baseline to Week 4, Week 8 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 posted21 Sep 2020
- Study start1 Oct 2020
- Primary completion16 Feb 2022
- Study completion16 Feb 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 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- 10 subjects will receive Restasis and Dextenza 10 subjects will receive Restasis and Lotemax 10 subjects will receive Restasis
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Chester, OD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Thomas Chester, OD, Cleveland Eye Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04555694
- Sponsor's protocol ID
- TC-2020-DexRes
- Status last verified
- Sep 2023
- First submitted
- 14 Sep 2020
- Last updated
- 11 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- 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 11 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intracanalicular Dexamethasone Used in Conjunction With Restasis (Cyclosporine Ophthalmic Emulsion) for the Treatment of Signs and Symptoms of Dry Eye Disease as Compared to Restasis With Lotemax (Loteprednol Etabonate Ophthalmic Suspension 0.5%) and Restasis Monotherapy.
- ClinicalTrials.gov ID
- NCT04555694
- Acronym / sponsor ID
- TC-2020-DexRes
- Conditions
- Dry Eye
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Thomas Chester, ODUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 16 Feb 2022 (actual)
- Study completion
- 16 Feb 2022 (actual)
- First posted
- 21 Sep 2020 (actual)
- Results
- Posted 11 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This 6 month study seeks to compare the use of Intracanalicular Dexamethasone in conjunction with Restasis (cyclosporine ophthalmic emulsion) for the treatment of signs and symptoms of dry eye disease as compared to Restasis with Lotemax (loteprednol etabonate ophthalmic suspension 0.5%) and Restasis monotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 10 subjects will receive Restasis and Dextenza 10 subjects will receive Restasis and Lotemax 10 subjects will receive Restasis
| Arm | Type | Receives |
|---|---|---|
| Restasis and Lotemax | Active comparator | Drug: Cyclosporine, Drug: Loteprednol Etabonate10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes and Lotemax ophthalmic solution twice a day in both eyes. |
| Restasis and Dextenza | Active comparator | Drug: Cyclosporine, Drug: Dexamethasone Ophthalmic 0.4 Mg Ophthalmic Insert10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes, as well as receiving Dextenza insertion in both lower lids. |
| Restasis | Active comparator | Drug: Cyclosporine10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years of age or older
- Signs and symptoms of Dry Eye Disease
- Consent to treat with topical immunomodulator
- Willing and able to comply with clinic visits and study related procedures
- Willing and able to sign the informed consent form
Key exclusion criteria (9 listed)
- Patients under the age of 18.
- Pregnancy (must be ruled out in women of child-bearing age with pregnancy test)
- Active infectious systemic disease
- Active infectious ocular or extraocular disease
- Altered nasolacrimal flow of either acquired, induced, or congenital origin
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: RestasisUsed to increase tear production in patients who have dry eye caused by inflammation | Drug | Restasis, Restasis and Dextenza, Restasis and Lotemax |
| Loteprednol EtabonateAlso: LotemaxUsed to treat inflammation of the eye | Drug | Restasis and Lotemax |
| Dexamethasone Ophthalmic 0.4 Mg Ophthalmic InsertAlso: DextenzaUsed to treat inflammation of the eye | Drug | Restasis and Dextenza |
Primary outcome
Mean Ocular Surface Staining From Baseline
Time frame: Baseline to Week 4, Week 8 and Week 12
The primary outcome measure was the mean corneal surface staining (guided by use of fluorescein and lissamine green) at weeks 4, 8 and 12 from baseline based on the National Eye Institute grading scale. Corneal fluorescein staining was scored from 0 to 3 on the scale (none, better to heavy, worse) in five regions of the cornea and summed for a total score of 0-15.
6 secondary outcomes
Mean Conjunctival Staining
Time frame: Baseline to Week 4, Week 8 and Week 12
Mean Schirmer Tear Test 1 Score
Time frame: Baseline to Week 4, Week 8 and Week 12
Tear Breakup Time (Seconds)
Time frame: Baseline to Week 4, Week 8 and Week 12
Tear Osmolarity
Time frame: Baseline to Week 4, Week 8 and Week 12
Meibomian Gland Scores
Time frame: Baseline to Week 4, Week 8 and Week 12
DEQ-5 Score
Time frame: Baseline to Week 4, Week 8 and Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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 Phase 4 study testing Cyclosporine, Loteprednol Etabonate and Dexamethasone Ophthalmic 0.4 Mg Ophthalmic Insert in people with Dry Eye, run by Thomas Chester, OD 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 5 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 11 Oct 2023. 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?
Yes. Results are posted in the registry (first posted 11 Oct 2023). 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 Ocular Surface Staining From Baseline (time frame: Baseline to Week 4, Week 8 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 11 Oct 2023.