PresbyopiaPhase 2OPSISNCT05665387
Study Assessing the Efficacy and Safety of STN1013600 Ophthalmic Solution 0.1% and 0.3% Compared With Placebo in Subjects With Presbyopia
A Phase 2 study testing 0.1% STN1013600 ophthalmic solution and 0.3% STN1013600 ophthalmic solution in people with Presbyopia, run by Santen Inc. at 12 sites in United States.
Trial summary
This is a Phase IIa study to assess efficacy and safety of STN1013600 ophthalmic solution (0.1%, and 0.3 %), twice daily when compared to Placebo in subjects diagnosed with presbyopia. This study will consist of a Screening Period of up to 15 days followed by a 2 Month Treatment Period. Read more about this study
- Who is it for?
- Ages 47 to 55 years
- Conditions the study is for
- Presbyopia
- What is being tested?
- 0.1% STN1013600 ophthalmic solution and 0.3% STN1013600 ophthalmic solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 79 participants
- Where
- 12 sitesUnited States
- Study dates
- 22 Dec 2022to 27 Jul 2023
- Phase
- Phase 2
- 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 47 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Phakic presbyopic subjects, Male or Female between 47 and 55 years of age.
- Distance-corrected near visual acuity (DCNVA) for each eye, as well as for binocular vision, 70 EDTRS letters or worse (equivalent to 0.3 logMAR or worse; or 20/40 Snellen or worse) at 40 cm. To be reconfirmed at Visit 2 (Baseline).
- Best-corrected distance visual acuity (BCDVA) for each eye of 85 ETDRS letters or better (equivalent to 0.00 logMAR or better; or 20/20 Snellen or better) at 4 m. To be reconfirmed at Visit 2 (Baseline).
Who cannot join
- Secondary cause of presbyopia in either eye as assessed by investigator (e.g., damage to lens, zonules or ciliary muscle, multiple sclerosis, cardiovascular accidents, vascular insufficiency, myasthenia gravis, anemia, influenza, measles).
- Any history of ocular surgery (including ocular laser surgery) in either eye or plan of ocular surgery (including ocular laser surgery) during the course of the study.
- Prior invasive therapy for presbyopia (e.g., ciliary body electrostimulation, corneal implants).
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Asheville Eye Associates
Asheville, North Carolina, 28803
Scott Christie and Associates PC
Cranberry Township, Pennsylvania, 16066
The Cataract and Glaucoma Center
El Paso, Texas, 79902
Global Research Management Inc
Glendale, California, 91204
University Eye Specialists
Maryville, Tennessee, 37803
Total Eye Care PA
Memphis, Tennessee, 38119
Clayton Eye Clinical Research, LLC
Morrow, Georgia, 30260
Eye Research Foundation
Newport Beach, California, 92663
Rochester Ophthalmological Group, P.C.
Rochester, New York, 14618
R and R Eye Research LLC
San Antonio, Texas, 78229
Vance Thompson Vision Clinic
Sioux Falls, South Dakota, 57108
Comprehensive Eye Care, Ltd
Washington, Missouri, 63090
About this study
Official title: OPSIS: A Phase IIa, Randomized, Double-Masked, Placebo-Controlled, Parallel-Group, Multicenter Study Assessing the Efficacy and Safety of STN1013600 Ophthalmic Solution 0.1% and 0.3% Compared With Placebo in Subjects With Presbyopia
This is a Phase IIa study to assess efficacy and safety of STN1013600 ophthalmic solution (0.1%, and 0.3 %), twice daily when compared to Placebo in subjects diagnosed with presbyopia. This study will consist of a Screening Period of up to 15 days followed by a 2 Month Treatment Period. After the Treatment Period subjects will be followed for a one-month treatment free period.
- Conditions
- Presbyopia
- Being tested
- 0.1% STN1013600 ophthalmic solution, 0.3% STN1013600 ophthalmic solution, Placebo
- Keywords
- Santen, Presbyopia, Eye
- Medical subject headings
- Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.1% STN1013600 ophthalmic solutionDrug
0.1% STN1013600 ophthalmic solution 1 drop BID for 2 months
0.3% STN1013600 ophthalmic solutionDrug
0.3% STN1013600 ophthalmic solution 1 drop BID for 2 months
PlaceboDrug
Placebo ophthalmic solution 1 drop BID for 2 months
| Study group | Role | What they receive |
|---|---|---|
| 0.1% STN1013600 ophthalmic solution | Experimental | 0.1% STN1013600 ophthalmic solution 1 drop BID Receives: Drug: 0.1% STN1013600 ophthalmic solution |
| 0.3% STN1013600 ophthalmic solution | Experimental | 0.3% STN1013600 ophthalmic solution 1 drop BID Receives: Drug: 0.3% STN1013600 ophthalmic solution |
| Placebo (Vehicle) ophthalmic solution | Placebo comparator | Placebo (Vehicle) ophthalmic solution BID Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change From Baseline in Binocular Distance Corrected Near Visual Acuity (DCNVA)
Analysis of Change from Baseline at Month 2 was done using Bayesian Approach Analysis Population.
Measured: At Month 2
Secondary outcomes (4)
Mean Change From Baseline in Study Eye Distance Corrected Near Visual Acuity (DCNVA) at Month 2
Summary of Early Treatment Diabetic Retinopathy Study (ETDRS) Letters and Change from Baseline by Analysis Visit.
Measured: Month 2
Percentage of Participants Who Improved 1/2/3-lines or More in Study Eye and Binocular Distance Corrected Near Visual Acuity (DCNVA) at Month 2
The response rate is the percentage of participants that achieved the specified gain in Distance Corrected Intermediate Visual Acuity (DCIVA) without losing more than 5 ETDRS (Early Treatment Diabetic Retinopathy Study) letters in Best Corrected Distance Visual Acuity (BCDVA)
Measured: Month 2
Mean Change From Baseline in Quality of Life Assessed With Near Activity Visual Questionnaire (NAVQ) at Month 2
Analysis of change from baseline in Rasch Score was done using Mixed-Effects Model for Repeated Measures (MMRM). Least Square Means were obtained by fitting a MMRM model to the NAVQ values.
The summated NAVQ score from initial 10 questions ranged from 0 to 30, where higher score indicates more difficulty with near tasks. The summated NAVQ score is converted to Rasch score which ranged from 0 to 100, with higher values indicating more difficulty with near tasks.
Measured: Month 2
Subject Treatment Satisfaction as Assessed by Patient Global Rating of Treatment
The response rate is the percent of participants that responded with "Satisfactory" or "Very Satisfactory" when asked to rate the overall satisfaction with the treatment.
Measured: Month 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2022
- Study start22 Dec 2022
- Primary completion27 Jul 2023
- Study completion27 Jul 2023
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 PresbyopiaStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Santen Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05665387
- Sponsor's protocol ID
- 101360002IN
- Acronym
- OPSIS
- Status last verified
- May 2024
- First submitted
- 16 Dec 2022
- Last updated
- 29 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- 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 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OPSIS: A Phase IIa, Randomized, Double-Masked, Placebo-Controlled, Parallel-Group, Multicenter Study Assessing the Efficacy and Safety of STN1013600 Ophthalmic Solution 0.1% and 0.3% Compared With Placebo in Subjects With Presbyopia
- ClinicalTrials.gov ID
- NCT05665387
- Acronym / sponsor ID
- OPSIS / 101360002IN
- Conditions
- Presbyopia
- Keywords
- Santen, Presbyopia, Eye
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Santen Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Dec 2022 (actual)
- Primary completion
- 27 Jul 2023 (actual)
- Study completion
- 27 Jul 2023 (actual)
- First posted
- 27 Dec 2022 (actual)
- Results
- Posted 29 May 2024
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 IIa study to assess efficacy and safety of STN1013600 ophthalmic solution (0.1%, and 0.3 %), twice daily when compared to Placebo in subjects diagnosed with presbyopia. This study will consist of a Screening Period of up to 15 days followed by a 2 Month Treatment Period. After the Treatment Period subjects will be followed for a one-month treatment free period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 0.1% STN1013600 ophthalmic solution | Experimental | Drug: 0.1% STN1013600 ophthalmic solution0.1% STN1013600 ophthalmic solution 1 drop BID |
| 0.3% STN1013600 ophthalmic solution | Experimental | Drug: 0.3% STN1013600 ophthalmic solution0.3% STN1013600 ophthalmic solution 1 drop BID |
| Placebo (Vehicle) ophthalmic solution | Placebo comparator | Drug: PlaceboPlacebo (Vehicle) ophthalmic solution BID |
Who may qualify
- Ages
- 47 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Phakic presbyopic subjects, Male or Female between 47 and 55 years of age.
- Distance-corrected near visual acuity (DCNVA) for each eye, as well as for binocular vision, 70 EDTRS letters or worse (equivalent to 0.3 logMAR or worse; or 20/40 Snellen or worse) at 40 cm. To be reconfirmed at Visit 2 (Baseline).
- Best-corrected distance visual acuity (BCDVA) for each eye of 85 ETDRS letters or better (equivalent to 0.00 logMAR or better; or 20/20 Snellen or better) at 4 m. To be reconfirmed at Visit 2 (Baseline).
Key exclusion criteria (3 listed)
- Secondary cause of presbyopia in either eye as assessed by investigator (e.g., damage to lens, zonules or ciliary muscle, multiple sclerosis, cardiovascular accidents, vascular insufficiency, myasthenia gravis, anemia, influenza, measles).
- Any history of ocular surgery (including ocular laser surgery) in either eye or plan of ocular surgery (including ocular laser surgery) during the course of the study.
- Prior invasive therapy for presbyopia (e.g., ciliary body electrostimulation, corneal implants).
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 |
|---|---|---|
| 0.1% STN1013600 ophthalmic solution0.1% STN1013600 ophthalmic solution 1 drop BID for 2 months | Drug | 0.1% STN1013600 ophthalmic solution |
| 0.3% STN1013600 ophthalmic solution0.3% STN1013600 ophthalmic solution 1 drop BID for 2 months | Drug | 0.3% STN1013600 ophthalmic solution |
| PlaceboPlacebo ophthalmic solution 1 drop BID for 2 months | Drug | Placebo (Vehicle) ophthalmic solution |
Primary outcome
Mean Change From Baseline in Binocular Distance Corrected Near Visual Acuity (DCNVA)
Time frame: At Month 2
Analysis of Change from Baseline at Month 2 was done using Bayesian Approach Analysis Population.
4 secondary outcomes
Mean Change From Baseline in Study Eye Distance Corrected Near Visual Acuity (DCNVA) at Month 2
Time frame: Month 2
Percentage of Participants Who Improved 1/2/3-lines or More in Study Eye and Binocular Distance Corrected Near Visual Acuity (DCNVA) at Month 2
Time frame: Month 2
Mean Change From Baseline in Quality of Life Assessed With Near Activity Visual Questionnaire (NAVQ) at Month 2
Time frame: Month 2
Subject Treatment Satisfaction as Assessed by Patient Global Rating of Treatment
Time frame: Month 2
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 0.1% STN1013600 ophthalmic solution and 0.3% STN1013600 ophthalmic solution in people with Presbyopia, run by Santen Inc. at 12 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 3 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 29 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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 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?
Yes. Results are posted in the registry (first posted 29 May 2024). 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 Change From Baseline in Binocular Distance Corrected Near Visual Acuity (DCNVA) (time frame: At Month 2). 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 29 May 2024.