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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06543303




Registration number
NCT06543303
Ethics application status
Date submitted
5/08/2024
Date registered
9/08/2024
Date last updated
19/08/2024

Titles & IDs
Public title
Evaluation of BTV100 in Subjects With Dry Eye Disease
Scientific 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
Secondary ID [1] 0 0
BTV100-CS201
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dry Eye 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BTV100 Low dose
Treatment: Drugs - BTV100 Mid dose
Treatment: Drugs - BTV100 High dose
Treatment: Drugs - Placebo

Experimental: BTV100 Low dose - 1% Cevimeline Ophthalmic Solution

Experimental: BTV100 Mid dose - 2% Cevimeline Ophthalmic Solution

Experimental: BTV High dose - 4% Cevimeline Ophthalmic Solution

Placebo comparator: Vehicle - Vehicle


Treatment: Drugs: BTV100 Low dose
1% Cevimeline Ophthalmic Solution

Treatment: Drugs: BTV100 Mid dose
2% Cevimeline Ophthalmic Solution

Treatment: Drugs: BTV100 High dose
4% Cevimeline Ophthalmic Solution

Treatment: Drugs: Placebo
Placebo
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Schirmer test
Timepoint [1] 0 0
Day 85
Secondary outcome [1] 0 0
Schirmer test
Timepoint [1] 0 0
Day 15, 29, 57 and 85.

Eligibility
Key inclusion criteria
1. 18 years of age or older (regardless of gender).
2. Provide written informed consent.
3. Willing and able to follow instructions and be available for required study visits during the study.
4. Best Corrected Visual Acuity (BCVA) of 20/100 or better in both eyes.
5. 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:
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Known hypersensitivity or contraindication to the study drug or its components.
2. 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)
3. Current use of contact lenses or anticipated use during the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
15/11/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
15/02/2026
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Sydney Eye Hospital - Sydney
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
Taiwan
State/province [1] 0 0
Kaohsiung
Country [2] 0 0
Taiwan
State/province [2] 0 0
Taoyuan

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
BioTheraVision, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Mulan Lee, PhD
Address 0 0
BioTheraVision, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Mulan Lee, PhD
Address 0 0
Country 0 0
Phone 0 0
714.679.8219
Fax 0 0
Email 0 0
mlee@biotheravision.com
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06543303