Dry EyePhase 2NCT06543303
Evaluation of BTV100 in Subjects With Dry Eye Disease
A Phase 2 study testing BTV100 Low dose, BTV100 Mid dose and BTV100 High dose in people with Dry Eye, run by BioTheraVision, Inc. at 6 sites in 2 countries.
Trial summary
This study will be a randomized, vehicle-controlled, double-masked, multiple-dose, parallel-group study to evaluate the efficacy, safety and tolerability of repeat dosing of Cevimeline Ophthalmic Solution compared to the vehicle in subjects with Dry Eye Disease (DED). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye
- What is being tested?
- BTV100 Low dose, BTV100 Mid dose and BTV100 High dose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 123 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 31 Dec 2024to 14 Jan 2026
- Phase
- Phase 2
- 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
- 18 years of age or older (regardless of gender).
- Provide written informed consent.
- Willing and able to follow instructions and be available for required study visits during the study.
- Best Corrected Visual Acuity (BCVA) of 20/100 or better in both eyes.
- Ongoing moderate to severe Dry Eye Disease (DED) supported by a previous clinical diagnosis or a self-reported history of subjective complaints for at least 6 months prior to the screening visit, and meet all the following criteria in at least one eye (the same eye) at Visit 1 and Visit 2:
Who cannot join
- Known hypersensitivity or contraindication to the study drug or its components.
- Within 28 days prior to the screening visit (Visit 1), have taken or used: Topical ophthalmic, dermatologic or systemic calcineurin inhibitor (e.g. cyclosporine and tacrolimus), including Restasis® (cyclosporine) and Cequa® (cyclosporine)
- Current use of contact lenses or anticipated use during the study.
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Taiwan4 sites
Chang Gung Memorial Hospital-Kaohsiung Branch
Kaohsiung City
Kaohsiung Veterans General Hospital
Kaohsiung City
Taipei Veterans General Hospital
Taipei
Chang Gung Memorial Hospital-LinKou Branch
Taoyuan
Australia2 sites
Cataract and Eye Surgery Centre, Victoria
Doncaster East, Victoria
Sydney Eye Hospital
Sydney
About this study
Official title: A Phase 2, Double-Masked, Randomized, Vehicle-controlled Trial Evaluating the Efficacy and Safety of Cevimeline Ophthalmic Solution Compared to Vehicle in Subjects With Dry Eye Disease
This study will be a randomized, vehicle-controlled, double-masked, multiple-dose, parallel-group study to evaluate the efficacy, safety and tolerability of repeat dosing of Cevimeline Ophthalmic Solution compared to the vehicle in subjects with Dry Eye Disease (DED).
Read the detailed description
At the screening visit/Visit 1 (Day 1 minus 14 days), subjects who are eligible according to the inclusion and exclusion criteria will begin a 14-day run-in period during which they will self-administer 1 drop of single-masked vehicle to each eye twice daily (BID), morning and evening (at least 6-hour interval). At the time of the screening visit/Visit 1, subjects will be instructed to discontinue all over the counter (OTC) and prescription topical ophthalmic medications except for the vehicle or study drug throughout the study.
At Baseline/Visit 2 (Day 1), subjects who continue fulfilling inclusion/exclusion criteria will be randomized to study drug or vehicle.
Approximately120 subjects will be randomized. Subjects will be randomized to one of the following 4 treatment groups. Following randomization, subjects being masked to treatment assignments will be instructed to self-administer 1 drop of investigational product (IP) into each eye twice daily, morning and evening (at least 6-hour interval). Subjects will be instructed to return to the clinic to be evaluated at Day 15 (Visit 3), Day 29 (Visit 4), Day 57 (Visit 5), and Day 85 (Visit 6).
- Conditions
- Dry Eye
- Being tested
- BTV100 Low dose, BTV100 Mid dose, BTV100 High dose, Placebo
- 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.
BTV100 Low doseDrug
1% Cevimeline Ophthalmic Solution
BTV100 Mid doseDrug
2% Cevimeline Ophthalmic Solution
BTV100 High doseDrug
4% Cevimeline Ophthalmic Solution
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| BTV100 Low dose | Experimental | 1% Cevimeline Ophthalmic Solution Receives: Drug: BTV100 Low dose |
| BTV100 Mid dose | Experimental | 2% Cevimeline Ophthalmic Solution Receives: Drug: BTV100 Mid dose |
| BTV High dose | Experimental | 4% Cevimeline Ophthalmic Solution Receives: Drug: BTV100 High dose |
| Vehicle | Placebo comparator | Vehicle Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Schirmer test
Change from baseline in unanesthetized Schirmer test of study eye
Measured: Day 85
Secondary outcomes (1)
Schirmer test
Proportion of subjects with an increase in unanesthetized Schirmer of 10 mm or more for study eye
Measured: Day 15, 29, 57 and 85.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start31 Dec 2024
- Primary completion14 Jan 2026
- Study completion14 Jan 2026
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-masked, randomized, parallel
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioTheraVision, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mulan Lee, PhD, Study director, BioTheraVision, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06543303
- Sponsor's protocol ID
- BTV100-CS201
- Status last verified
- Oct 2026
- First submitted
- 5 Aug 2024
- Last updated
- 7 Oct 2026
- Results posted
- No
- 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 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Double-Masked, Randomized, Vehicle-controlled Trial Evaluating the Efficacy and Safety of Cevimeline Ophthalmic Solution Compared to Vehicle in Subjects With Dry Eye Disease
- ClinicalTrials.gov ID
- NCT06543303
- Acronym / sponsor ID
- BTV100-CS201
- Conditions
- Dry Eye
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- BioTheraVision, Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Dec 2024 (actual)
- Primary completion
- 14 Jan 2026 (actual)
- Study completion
- 14 Jan 2026 (actual)
- First posted
- 9 Aug 2024 (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.
This study will be a randomized, vehicle-controlled, double-masked, multiple-dose, parallel-group study to evaluate the efficacy, safety and tolerability of repeat dosing of Cevimeline Ophthalmic Solution compared to the vehicle in subjects with Dry Eye Disease (DED).
Detailed description
At the screening visit/Visit 1 (Day 1 minus 14 days), subjects who are eligible according to the inclusion and exclusion criteria will begin a 14-day run-in period during which they will self-administer 1 drop of single-masked vehicle to each eye twice daily (BID), morning and evening (at least 6-hour interval). At the time of the screening visit/Visit 1, subjects will be instructed to discontinue all over the counter (OTC) and prescription topical ophthalmic medications except for the vehicle or study drug throughout the study.
At Baseline/Visit 2 (Day 1), subjects who continue fulfilling inclusion/exclusion criteria will be randomized to study drug or vehicle.
Approximately120 subjects will be randomized. Subjects will be randomized to one of the following 4 treatment groups. Following randomization, subjects being masked to treatment assignments will be instructed to self-administer 1 drop of investigational product (IP) into each eye twice daily, morning and evening (at least 6-hour interval). Subjects will be instructed to return to the clinic to be evaluated at Day 15 (Visit 3), Day 29 (Visit 4), Day 57 (Visit 5), and Day 85 (Visit 6).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Double-masked, randomized, parallel
| Arm | Type | Receives |
|---|---|---|
| BTV100 Low dose | Experimental | Drug: BTV100 Low dose1% Cevimeline Ophthalmic Solution |
| BTV100 Mid dose | Experimental | Drug: BTV100 Mid dose2% Cevimeline Ophthalmic Solution |
| BTV High dose | Experimental | Drug: BTV100 High dose4% Cevimeline Ophthalmic Solution |
| Vehicle | Placebo comparator | Drug: PlaceboVehicle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years of age or older (regardless of gender).
- Provide written informed consent.
- Willing and able to follow instructions and be available for required study visits during the study.
- Best Corrected Visual Acuity (BCVA) of 20/100 or better in both eyes.
- Ongoing moderate to severe Dry Eye Disease (DED) supported by a previous clinical diagnosis or a self-reported history of subjective complaints for at least 6 months prior to the screening visit, and meet all the following criteria in at least one eye (the same eye) at Visit 1 and Visit 2:
Key exclusion criteria (3 listed)
- Known hypersensitivity or contraindication to the study drug or its components.
- Within 28 days prior to the screening visit (Visit 1), have taken or used: Topical ophthalmic, dermatologic or systemic calcineurin inhibitor (e.g. cyclosporine and tacrolimus), including Restasis® (cyclosporine) and Cequa® (cyclosporine)
- Current use of contact lenses or anticipated use during the study.
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 |
|---|---|---|
| BTV100 Low dose1% Cevimeline Ophthalmic Solution | Drug | BTV100 Low dose |
| BTV100 Mid dose2% Cevimeline Ophthalmic Solution | Drug | BTV100 Mid dose |
| BTV100 High dose4% Cevimeline Ophthalmic Solution | Drug | BTV High dose |
| PlaceboPlacebo | Drug | Vehicle |
Primary outcome
Schirmer test
Time frame: Day 85
Change from baseline in unanesthetized Schirmer test of study eye
1 secondary outcome
Schirmer test
Time frame: Day 15, 29, 57 and 85.
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 7 Oct 2026.
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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.
Mulan Lee, PhD study director
BioTheraVision, Inc.
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BTV100 Low dose, BTV100 Mid dose and BTV100 High dose in people with Dry Eye, run by BioTheraVision, Inc. at 6 sites in 2 countries.
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 3 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 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Taiwan, Australia. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Schirmer test (time frame: Day 85). 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 7 Oct 2026.