Myopia, ProgressivePhase 3NCT04770610
Study of OT-101 in Treating Myopia
A Phase 3 study testing OT-101 Ophthalmic Solution in people with Myopia, Progressive, run by Ocumension (Hong Kong) Limited at 15 sites in United States.
Trial summary
This is a phase III, randomized, double-masked, placebo-controlled, parallel-group, multicenter safety, tolerability, and efficacy study of atropine sulfate 0.01% (OT-101) as an investigational treatment for myopia in pediatric subjects Read more about this study
- Who is it for?
- Ages 3 to 15 years
- Conditions the study is for
- Myopia, Progressive
- What is being tested?
- OT-101 Ophthalmic Solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 678 participants
- Where
- 15 sitesUnited States
- Study dates
- 1 Apr 2021to Apr 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 3 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Have refractive error by cycloplegic autorefraction at baseline (Visit 1) in the study eye of:
- myopia greater or equal to -1.00D of spherical equivalent
- astigmatism less than or equal to 1.50DC
- progression of at least -0.50D of spherical equivalent in the last 12 months;
Who cannot join
- Have active or a history of chronic or recurrent episodes of ocular inflammation (e.g. moderate to severe blepharitis, allergic conjunctivitis, peripheral ulcerative keratitis, scleritis) in either eye;
- Have undergone any myopia control treatment including orthokeratology, rigid gas-permeable contact lenses, bifocal contact lenses, progressive addition spectacle lenses, or other lenses to reduce myopia progression in the previous 6 months. Myopic correction in the form of single-vision eyeglasses and/or single-vision soft contact lenses are allowed;
- Have undergone any form of refractive eye surgery including incisional keratotomy, photorefractive keratectomy [PRK], laser in situ keratomileusis [LASIK], laser-assisted sub- epithelial keratectomy [LASEK]), corneal inlay procedures, conductive keratoplasty, small incision lenticule extraction (SMILE), cataract extraction, or any form of intraocular lens implantation;
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Colorado Vision Institute
Colorado Springs, Colorado, 80907
Scott & Christie and Associates
Cranberry Township, Pennsylvania, 16066
Pediatric Ophthalmology of Erie, Inc
Erie, Pennsylvania, 16501
Eye Center of Northern Colorado, PC
Fort Collins, Colorado, 80528
Family Focus
Gainesville, Florida, 32607
Indiana University Health Physicians Pediatric Ophthalmology
Indianapolis, Indiana, 46202
Pediatric Eye Consultants of North Florida
Jacksonville, Florida, 32202
Total Eye Care, P.A.
Memphis, Tennessee, 38119
Pure Ophthalmic Research
Mint Hill, North Carolina, 28227
UPMC Children's Hospital
Pittsburgh, Pennsylvania, 15224
Kids Eye Care of Maryland
Rockville, Maryland, 20850
San Antonio Eye Center
San Antonio, Texas, 78215
CORE, Inc.
Shelby, North Carolina, 28150
Comprehensive Eye Care, Ltd.
Washington, Missouri, 63090
About this study
Official title: A Phase III, Randomized, Double-masked, Placebo-controlled, Parallel-group, Multicenter Study of the Safety and Efficacy of OT-101 (Atropine Sulfate 0.01%) in Treating the Progression of Myopia in Pediatric Subjects
This is a phase III, randomized, double-masked, placebo-controlled, parallel-group, multicenter safety, tolerability, and efficacy study of atropine sulfate 0.01% (OT-101) as an investigational treatment for myopia in pediatric subjects
Read the detailed description
This is a phase III, randomized, double-masked, placebo-controlled, parallel-group, multi-center study to evaluate the safety tolerability and efficacy of OT-101 (Atropine 0.01%) Ophthalmic Solution in treating the progression of myopia in pediatric subjects that will enroll approximately 678 pediatric subjects with myopia in total. Subjects will be stratified by age and refractive error.
This study consists of 11 visits over the course of approximately 4 years and can be broken down in the 3 stages: Screening (Days -14 to -1), Stage 1 (Day 1 to Year 3), and Stage 2 (Year 3 to Year 4). In stage 1, subjects will be randomized in a 2:1 manner to OT-101 Ophthalmic Solution: Placebo. Subjects will be dosed with one drop of study treatment per eye once daily at bedtime for 3 years. In stage 2, subjects will be re-randomization 1:1 will occur at Visit 9 (Month 36). At re-randomization, subjects who had been assigned to OT-101 Ophthalmic Solution will be randomized in a 1:1 ratio to continue on OT-101 Ophthalmic Solution or switch to placebo. Subjects who had been assigned to placebo will continue with placebo.
- Conditions
- Myopia, Progressive
- Being tested
- OT-101 Ophthalmic Solution, Vehicle
- Medical subject headings
- Myopia, Degenerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OT-101 Ophthalmic SolutionDrug
Also called Investigational Product
Atropine 0.01%
VehicleDrug
Also called Placebo
Investigational Product minus active ingredient
| Study group | Role | What they receive |
|---|---|---|
| OT-101 alone | Experimental | Atropine Sulfate 0.01% Ophthalmic Solution through year 4 Receives: Drug: OT-101 Ophthalmic Solution |
| OT-101 plus vehicle | Experimental | Atropine Sulfate 0.01% Ophthalmic Solution through year 3 followed by vehicle for 1 year Receives: Drug: OT-101 Ophthalmic Solution; Drug: Vehicle |
| Vehicle | Placebo comparator | Vehicle (Investigational Product minus active ingredient) through year 4 Receives: Drug: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of study eyes with a -0.75D of progressive myopia defined as an increase in spherical equivalent of -0.75D or greater as assessed by cycloplegic autorefraction.
Efficacy of OT-101 Ophthalmic Solution
Measured: At month 36
Secondary outcomes (2)
Change in spherical equivalent (D) in the study eye as assessed by cycloplegic autorefraction
Efficacy of OT-101 Ophthalmic Solution
Measured: Baseline to Month 36
Change in study eye axial length as measured by cycloplegic biometry (a standardized device will be selected for this study)
Efficacy of OT-101 Ophthalmic Solution
Measured: Baseline to Month 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2021
- Study start1 Apr 2021
- Primary completionMar 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myopia, ProgressiveStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 678 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ocumension (Hong Kong) Limited
- Sponsor type
- University, hospital or other
- Collaborators
- ORA, Inc., Statistics & Data Corporation
- Responsible party
- Sponsor
- Investigators
- Keith Lane, Study director, ORA, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04770610
- Sponsor's protocol ID
- OT_101_001
- Status last verified
- Aug 2023
- First submitted
- 22 Feb 2021
- Last updated
- 8 Aug 2023
- 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 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized, Double-masked, Placebo-controlled, Parallel-group, Multicenter Study of the Safety and Efficacy of OT-101 (Atropine Sulfate 0.01%) in Treating the Progression of Myopia in Pediatric Subjects
- ClinicalTrials.gov ID
- NCT04770610
- Acronym / sponsor ID
- OT_101_001
- Conditions
- Myopia, Progressive
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 678 participants (estimated)
- Lead sponsor
- Ocumension (Hong Kong) LimitedUniversity, hospital or other
- Collaborators
- ORA, Inc., Statistics & Data Corporation
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 25 Feb 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.
This is a phase III, randomized, double-masked, placebo-controlled, parallel-group, multicenter safety, tolerability, and efficacy study of atropine sulfate 0.01% (OT-101) as an investigational treatment for myopia in pediatric subjects
Detailed description
This is a phase III, randomized, double-masked, placebo-controlled, parallel-group, multi-center study to evaluate the safety tolerability and efficacy of OT-101 (Atropine 0.01%) Ophthalmic Solution in treating the progression of myopia in pediatric subjects that will enroll approximately 678 pediatric subjects with myopia in total. Subjects will be stratified by age and refractive error.
This study consists of 11 visits over the course of approximately 4 years and can be broken down in the 3 stages: Screening (Days -14 to -1), Stage 1 (Day 1 to Year 3), and Stage 2 (Year 3 to Year 4). In stage 1, subjects will be randomized in a 2:1 manner to OT-101 Ophthalmic Solution: Placebo. Subjects will be dosed with one drop of study treatment per eye once daily at bedtime for 3 years. In stage 2, subjects will be re-randomization 1:1 will occur at Visit 9 (Month 36). At re-randomization, subjects who had been assigned to OT-101 Ophthalmic Solution will be randomized in a 1:1 ratio to continue on OT-101 Ophthalmic Solution or switch to placebo. Subjects who had been assigned to placebo will continue with placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| OT-101 alone | Experimental | Drug: OT-101 Ophthalmic SolutionAtropine Sulfate 0.01% Ophthalmic Solution through year 4 |
| OT-101 plus vehicle | Experimental | Drug: OT-101 Ophthalmic Solution, Drug: VehicleAtropine Sulfate 0.01% Ophthalmic Solution through year 3 followed by vehicle for 1 year |
| Vehicle | Placebo comparator | Drug: VehicleVehicle (Investigational Product minus active ingredient) through year 4 |
Who may qualify
- Ages
- 3 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Have refractive error by cycloplegic autorefraction at baseline (Visit 1) in the study eye of:
Key exclusion criteria (3 listed)
- Have active or a history of chronic or recurrent episodes of ocular inflammation (e.g. moderate to severe blepharitis, allergic conjunctivitis, peripheral ulcerative keratitis, scleritis) in either eye;
- Have undergone any myopia control treatment including orthokeratology, rigid gas-permeable contact lenses, bifocal contact lenses, progressive addition spectacle lenses, or other lenses to reduce myopia progression in the previous 6 months. Myopic correction in the form of single-vision eyeglasses and/or single-vision soft contact lenses are allowed;
- Have undergone any form of refractive eye surgery including incisional keratotomy, photorefractive keratectomy [PRK], laser in situ keratomileusis [LASIK], laser-assisted sub- epithelial keratectomy [LASEK]), corneal inlay procedures, conductive keratoplasty, small incision lenticule extraction (SMILE), cataract extraction, or any form of intraocular lens implantation;
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 |
|---|---|---|
| OT-101 Ophthalmic SolutionAlso: Investigational ProductAtropine 0.01% | Drug | OT-101 alone, OT-101 plus vehicle |
| VehicleAlso: PlaceboInvestigational Product minus active ingredient | Drug | OT-101 plus vehicle, Vehicle |
Primary outcome
Percentage of study eyes with a -0.75D of progressive myopia defined as an increase in spherical equivalent of -0.75D or greater as assessed by cycloplegic autorefraction.
Time frame: At month 36
Efficacy of OT-101 Ophthalmic Solution
2 secondary outcomes
Change in spherical equivalent (D) in the study eye as assessed by cycloplegic autorefraction
Time frame: Baseline to Month 36
Change in study eye axial length as measured by cycloplegic biometry (a standardized device will be selected for this study)
Time frame: Baseline to Month 36
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2023.
- 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.
Keith Lane study director
ORA, Inc.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing OT-101 Ophthalmic Solution in people with Myopia, Progressive, run by Ocumension (Hong Kong) Limited at 15 sites 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 4 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: under way, not looking for participants, as of the sponsor's last update on 8 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Percentage of study eyes with a -0.75D of progressive myopia defined as an increase in spherical equivalent of -0.75D or greater as assessed by cycloplegic autorefraction. (time frame: At month 36). 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 8 Aug 2023.