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Study Assessing the Efficacy and Safety of STN1013600 Ophthalmic Solution 0.1% and 0.3% Compared With Placebo in Subjects With Presbyopia
Phase 2 trial testing 0.1% STN1013600 ophthalmic solution in Presbyopia in 79 participants. Completed in 27 July 2023.
| Lead sponsor | Santen Inc. |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 79 |
| Start date | 22 December 2022 |
| Primary completion | 27 July 2023 |
| Estimated completion | 27 July 2023 |
| Sites | 12 locations across United States |
Santen Inc. — full company profile →
Adults 47 to 55, any sex, with Presbyopia. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Analysis of Change from Baseline at Month 2 was done using Bayesian Approach Analysis Population.
| Group | Value | 95% CI |
|---|---|---|
| 0.3% STN1013600 Ophthalmic Solution | 4.1 | ± 1.24 |
| 0.1% STN1013600 Ophthalmic Solution | 4.3 | ± 1.18 |
| Placebo (Vehicle) Ophthalmic Solution | 4.4 | ± 1.13 |
Summary of Early Treatment Diabetic Retinopathy Study (ETDRS) Letters and Change from Baseline by Analysis Visit.
| Group | Value | 95% CI |
|---|---|---|
| 0.3% STN1013600 Ophthalmic Solution | 62.2 | ± 6.29 |
| 0.1% STN1013600 Ophthalmic Solution | 63.5 | ± 4.84 |
| Placebo (Vehicle) Ophthalmic Solution | 63.8 | ± 4.71 |
| Group | Value | 95% CI |
|---|---|---|
| 0.3% STN1013600 Ophthalmic Solution | 66.4 | ± 6.69 |
| 0.1% STN1013600 Ophthalmic Solution | 67.9 | ± 8.10 |
| Placebo (Vehicle) Ophthalmic Solution | 68.7 | ± 7.58 |
| Group | Value | 95% CI |
|---|---|---|
| 0.3% STN1013600 Ophthalmic Solution | 4.2 | ± 6.65 |
| 0.1% STN1013600 Ophthalmic Solution | 4.4 | ± 7.15 |
| Placebo (Vehicle) Ophthalmic Solution | 4.8 | ± 5.88 |
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)
| Group | Value | 95% CI |
|---|---|---|
| 0.3% STN1013600 Ophthalmic Solution | 13 | |
| 0.1% STN1013600 Ophthalmic Solution | 17 | |
| Placebo (Vehicle) Ophthalmic Solution | 5 |
| Group | Value | 95% CI |
|---|---|---|
| 0.3% STN1013600 Ophthalmic Solution | 6 | |
| 0.1% STN1013600 Ophthalmic Solution | 12 | |
| Placebo (Vehicle) Ophthalmic Solution | 0 |
| Group | Value | 95% CI |
|---|---|---|
| 0.3% STN1013600 Ophthalmic Solution | 1 | |
| 0.1% STN1013600 Ophthalmic Solution | 5 | |
| Placebo (Vehicle) Ophthalmic Solution | 0 |
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.
| Group | Value | 95% CI |
|---|---|---|
| 0.3% STN1013600 Ophthalmic Solution | -7.493 | ± 2.1803 |
| 0.1% STN1013600 Ophthalmic Solution | -8.140 | ± 2.0939 |
| Placebo (Vehicle) Ophthalmic Solution | -10.510 | ± 3.1447 |
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.
| Group | Value | 95% CI |
|---|---|---|
| 0.3% STN1013600 Ophthalmic Solution | 13 | |
| 0.1% STN1013600 Ophthalmic Solution | 18 | |
| Placebo (Vehicle) Ophthalmic Solution | 9 |
Time frame: Adverse events in this study were collected from the time of informed consent and until subject withdrawal or until the subject's participation in the study ended at 3 Months.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | 0.3% STN1013600 Ophthalmic… | 0.1% STN1013600 Ophthalmic… | Placebo (Vehicle) Ophthalm… |
|---|---|---|---|---|
| Instillation site irritation | General disorders | — | — | — |
| Liver function test increased | Investigations | — | — | — |
| Eye irritation | Eye disorders | — | — | — |
| Foreign body sensation in eyes | Eye disorders | — | — | — |
| Retinal pigment epitheliopathy | Eye disorders | — | — | — |
| Visual acuity reduced | Eye disorders | — | — | — |
| Instillation site discomfort | General disorders | — | — | — |
| White blood cell count increased | Investigations | — | — | — |
| Neck pain | Musculoskeletal and connective tissue disorders | — | — | — |
| Periarthritis | Musculoskeletal and connective tissue disorders | — | — | — |
| Nausea | Gastrointestinal disorders | — | — | — |
| Hypokalaemia | Metabolism and nutrition disorders | — | — | — |
| Headache | Nervous system disorders | — | — | — |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | — | — | — |
| Hypertension | Vascular disorders | — | — | — |
| Limb injury | Injury, poisoning and procedural complications | — | — | — |
| Depression | Psychiatric disorders | — | — | — |
Data from ClinicalTrials.gov NCT05665387 adverse events section.
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.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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