Trial · NCT06349759
Safety and Efficacy of 0.75% Phentolamine Ophthalmic Solution in Subjects With Post-refractive Surgery Visual Disturbances
NCT06349759, Phase 3, Completed, Opus Genetics, Inc
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Efficacy of 0.75% Phentolamine Ophthalmic Solution in Subjects With Post-refractive Surgery Visual Disturbances. Trials, record NCT06349759. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06349759
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of 0.75% Phentolamine Ophthalmic Solution in Subjects With Post-refractive Surgery Visual Disturbances
- NCT number
- NCT06349759
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 200 participants, actual
- Lead sponsor
- Opus Genetics, Inc
- Conditions
- Mesopic Vision, Night Vision Loss
- Interventions
- phentolamine ophthalmic solution 0.75%, a non-selective alpha-1 and alpha-2 adrenergic antagonist, Placebo
- First posted
- 2024-04-05
- Last updated
- 2026-10-26
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Subjects With ≥ 15 Letters (3 Lines) Improvement in mLCVA in the Study Eye at Day 15 Compared to Baseline | 15 Days | This outcome measure will investigate the percent of subjects with an increase of at least 15 ETDRS letters read (≥ 3 lines) in the study eye in mLCVA compared to baseline (Day 1 pre-dose) at Day 15 in an effort to evaluate the efficacy of POS to improve mLCVA in subjects with post-refractive surgery visual disturbances. |
| Secondary | Percentage of Subjects With ≥ 10 and ≥ 15 ETDRS Letters Improvement in mLCVA Compared to Baseline (Day 1 Pre-dose) at Days 3, 8, and 15 (≥ 10 ETDRS Letters Only) and Week 6 | 6 Weeks | This outcome measure will investigate the percentage of subjects with ≥ 10 and ≥ 15 ETDRS letters improvement in mLCVA compared to baseline at Days 3, 8, and 15 (≥ 10 ETDRS letters only) and Week 6. |
| Secondary | Mean and Change From Baseline in mLCVA at 0.5, 1, and 3 Hours Post-dose on Day 1 | 3 hours | This outcome measure will investigate the mean and change from baseline in mLCVA at 0.5, 1, and 3 hours post-dose on Day 1. |
| Secondary | Percentage of Subjects With ≥ 10 and ≥ 15 ETDRS Letters Improvement in Mesopic High-contrast Best-corrected Distance Visual Acuity (mHCVA) Compared to Baseline (Day 1 Pre-Dose) at Days 3, 8, and 15 and Week 6 | 6 Weeks | This outcome measure will investigate the percentage of subjects with ≥ 10 and ≥ 15 ETDRS letters improvement in mesopic high-contrast best-corrected distance visual acuity (mHCVA) compared to baseline at Days 3, 8, and 15 and Week 6. |
| Secondary | Mean and Change From Baseline (Day 1 Pre-dose) in mLCVA and mHCVA at Days 3, 8, and 15 and Week 6 | 6 Weeks | This outcome measure will investigate the mean and change from baseline in mLCVA and mHCVA at Days 3, 8, and 15 and Week 6. |
| Secondary | Mean and Change From Baseline (Day 1 Pre-dose) in PD at Days 3, 8, and 15 and Week 6 | 6 Weeks | This outcome measure will investigate the mean and change from baseline in PD at Days 3, 8, and 15 and Week 6. |
| Secondary | Change in Subject Questionnaire Responses Compared to Baseline (Day 1 Pre-dose) at Days 3, 8, and 15 and Week 6 | 6 Weeks | This outcome measure will investigate the change in subject questionnaire responses compared to baseline at Days 3, 8, and 15 and Week 6. The Vision and Night Driving Questionnaire (VND-Q) is comprised of 9 questions related to visual difficulties when driving at night. Subjects were asked to assess, on a 1 (no difficulty) to 5 (extreme difficulty) scale, how much difficulty they had or would have with certain tasks while wearing their normal glasses or contact lenses (if any) for night driving. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT06349759
GET https://conductscience.org/api/trials/v1/NCT06349759/registered