Trial · NCT04599933
An Evaluation of the Efficacy and Safety of CSF-1 in the Temporary Correction of Presbyopia (NEAR-1)
NCT04599933, Phase 3, Completed, Orasis Pharmaceuticals Ltd.; results first posted 2023-11-28
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. An Evaluation of the Efficacy and Safety of CSF-1 in the Temporary Correction of Presbyopia (NEAR-1). Trials, record NCT04599933. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04599933
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Evaluation of the Efficacy and Safety of CSF-1 in the Temporary Correction of Presbyopia (NEAR-1)
- NCT number
- NCT04599933
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 309 participants, actual
- Lead sponsor
- Orasis Pharmaceuticals Ltd.
- Conditions
- Presbyopia
- Interventions
- CSF-1, Vehicle
- First posted
- 2020-10-23
- Last updated
- 2024-04-04
- Results first posted
- 2023-11-28
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Subjects With a ≥ 3-line Gain in BDCVA (Best Distance-Corrected Visual Acuity) at 40cm and no Loss in BDCVA ≥ 5 Letters at 4m on Day 8, 1 Hour Post-Dose 1. | Baseline (Day 1) to Day 8 (1 hour post-Dose 1) | The primary end-point was measured on Day 8, 1 hour post first CSF-1 dose, as the number of participants who are responders to the treatment. A responder was defined as as subject with a ≥ 3-line gain in BDCVA (Best Distance-Corrected Visual Acuity) at 40cm and no loss in BDCVA ≥ 5 letters at 4m. |
| Secondary | Percentage of Subjects With a ≥ 3-line Gain in BDCVA at 40cm and no Loss in BDCVA ≥ 5 Letters at 4m on Day 8 at 2 Hours Post-Dose 1 | Baseline (Day 1) to Day 8 (2 hours post-Dose 1) | The key secondary endpoints were measured on Day 8 at different time points and were the percentage of subjects with a ≥ 3-line (15-letter) gain, from baseline, in BDCVA at 40 cm (Precision Vision Chart) and no loss in BDCVA ≥ 5 letters (ETDRS chart at 4 m) in the study eye. |
| Secondary | Percentage of Subjects With a ≥ 3-line Gain in BDCVA at 40cm and no Loss in BDCVA ≥ 5 Letters at 4m on Day 8 at 1 Hour Post-Dose 2 | Baseline (Day 1) to Day 8 (1 hour post-Dose 2; Dose 2 occurs 2 hours following Dose 1) | The key secondary endpoints were measured on Day 8 at different time points and were the percentage of subjects with a ≥ 3-line (15-letter) gain, from baseline, in BDCVA at 40 cm (Precision Vision Chart) and no loss in BDCVA ≥ 5 letters (ETDRS chart at 4 m) in the study eye. |
| Secondary | Percentage of Subjects With a ≥ 3-line Gain in BDCVA at 40cm and no Loss in BDCVA ≥ 5 Letters at 4m on Day 8 at 2 Hours Post-dose 2 | Baseline (Day 1) to Day 8 (2 hours post-Dose 2; Dose 2 occurs 2 hours following Dose 1) | The key secondary endpoints were measured on Day 8 at different time points and were the percentage of subjects with a ≥ 3-line (15-letter) gain, from baseline, in BDCVA at 40 cm (Precision Vision Chart) and no loss in BDCVA ≥ 5 letters (ETDRS chart at 4 m) in the study eye. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Subjects With a ≥ 3-line Gain in BDCVA (Best Distance-Corrected Visual Acuity) at 40cm and no Loss in BDCVA ≥ 5 Letters at 4m on Day 8, 1 Hour Post-Dose 1. | Baseline (Day 1) to Day 8 (1 hour post-Dose 1) | Full analysis set (FAS): included all randomized subjects who received at least 1 dose of the study drug. Subjects in the FAS were analyzed as randomized. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Subjects With a ≥ 3-line Gain in BDCVA at 40cm and no Loss in BDCVA ≥ 5 Letters at 4m on Day 8 at 2 Hours Post-Dose 1 | Baseline (Day 1) to Day 8 (2 hours post-Dose 1) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Percentage of Subjects With a ≥ 3-line Gain in BDCVA at 40cm and no Loss in BDCVA ≥ 5 Letters at 4m on Day 8 at 1 Hour Post-Dose 2 | Baseline (Day 1) to Day 8 (1 hour post-Dose 2; Dose 2 occurs 2 hours following Dose 1) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Percentage of Subjects With a ≥ 3-line Gain in BDCVA at 40cm and no Loss in BDCVA ≥ 5 Letters at 4m on Day 8 at 2 Hours Post-dose 2 | Baseline (Day 1) to Day 8 (2 hours post-Dose 2; Dose 2 occurs 2 hours following Dose 1) | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Subjects With a ≥ 3-line Gain in BDCVA (Best Distance-Corrected Visual Acuity) at 40cm and no Loss in BDCVA ≥ 5 Letters at 4m on Day 8, 1 Hour Post-Dose 1. | CSF-1 | 60 | Participants | ||
| Percentage of Subjects With a ≥ 3-line Gain in BDCVA (Best Distance-Corrected Visual Acuity) at 40cm and no Loss in BDCVA ≥ 5 Letters at 4m on Day 8, 1 Hour Post-Dose 1. | Vehicle | 26 | Participants | ||
| Percentage of Subjects With a ≥ 3-line Gain in BDCVA at 40cm and no Loss in BDCVA ≥ 5 Letters at 4m on Day 8 at 2 Hours Post-Dose 1 | CSF-1 | 61 | Participants | ||
| Percentage of Subjects With a ≥ 3-line Gain in BDCVA at 40cm and no Loss in BDCVA ≥ 5 Letters at 4m on Day 8 at 2 Hours Post-Dose 1 | Vehicle | 26 | Participants | ||
| Percentage of Subjects With a ≥ 3-line Gain in BDCVA at 40cm and no Loss in BDCVA ≥ 5 Letters at 4m on Day 8 at 1 Hour Post-Dose 2 | CSF-1 | 74 | Participants | ||
| Percentage of Subjects With a ≥ 3-line Gain in BDCVA at 40cm and no Loss in BDCVA ≥ 5 Letters at 4m on Day 8 at 1 Hour Post-Dose 2 | Vehicle | 24 | Participants | ||
| Percentage of Subjects With a ≥ 3-line Gain in BDCVA at 40cm and no Loss in BDCVA ≥ 5 Letters at 4m on Day 8 at 2 Hours Post-dose 2 | CSF-1 | 60 | Participants | ||
| Percentage of Subjects With a ≥ 3-line Gain in BDCVA at 40cm and no Loss in BDCVA ≥ 5 Letters at 4m on Day 8 at 2 Hours Post-dose 2 | Vehicle | 23 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | CSF-1 | 155 | |
| Overall Study | STARTED | Vehicle | 154 | |
| Overall Study | COMPLETED | CSF-1 | 146 | |
| Overall Study | COMPLETED | Vehicle | 147 | |
| Overall Study | NOT COMPLETED | CSF-1 | 9 | |
| Overall Study | NOT COMPLETED | Vehicle | 7 |
Source ClinicalTrials.gov
Adverse events6
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | instillation site pain | General disorders | CSF-1 | 9 | 155 | |
| other | instillation site pain | General disorders | Vehicle | 1 | 154 | |
| other | headache | Nervous system disorders | CSF-1 | 8 | 155 | |
| other | headache | Nervous system disorders | Vehicle | 2 | 154 | |
| serious | Enteritis | Gastrointestinal disorders | CSF-1 | 0 | 155 | |
| serious | Enteritis | Gastrointestinal disorders | Vehicle | 1 | 154 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | CSF-1 | 0 | 155 |
| Total, all-cause mortality | Vehicle | 0 | 154 |
| Total, other adverse events | CSF-1 | 17 | 155 |
| Total, other adverse events | Vehicle | 3 | 154 |
| Total, serious adverse events | CSF-1 | 0 | 155 |
| Total, serious adverse events | Vehicle | 1 | 154 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 38216351 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons6
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| CSF-1 vs Vehicle: Percentage of Subjects With a ≥ 3-line Gain in BDCVA (Best Distance-Corrected Visual Acuity) at 40cm and no Loss in BDCVA ≥ 5 Letters at 4m on Day 8, 1 Hour Post-Dose 1. | Trial comparisons |
| CSF-1 vs Vehicle: Percentage of Subjects With a ≥ 3-line Gain in BDCVA at 40cm and no Loss in BDCVA ≥ 5 Letters at 4m on Day 8 at 1 Hour Post-Dose 2 | Trial comparisons |
| CSF-1 vs Vehicle: Percentage of Subjects With a ≥ 3-line Gain in BDCVA at 40cm and no Loss in BDCVA ≥ 5 Letters at 4m on Day 8 at 2 Hours Post-dose 2 | Trial comparisons |
| CSF-1 vs Vehicle: deaths from any cause | Trial comparisons |
| CSF-1 vs Vehicle: Percentage of Subjects With a ≥ 3-line Gain in BDCVA at 40cm and no Loss in BDCVA ≥ 5 Letters at 4m on Day 8 at 2 Hours Post-Dose 1 | Trial comparisons |
| CSF-1 vs Vehicle: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04599933
GET https://conductscience.org/api/trials/v1/NCT04599933/registered