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SURF-201 is being studied for the treatment of eye inflammation and pain in people who are undergoing cataract surgery. SURF-201 is an investigational drug (which means the study drug is currently being tested) in the form of a sterile eye drop.
The purpose of this research study is to see how well SURF-201 works and what side effects there are, and to compare it with Vehicle (placebo). This study will involve about 80 study participants at several different research sites in the United States.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SURF-201 | Experimental | 0.2% topical preservative-free corticosteroid solution (0.2% betamethasone sodium phosphate) |
|
| Vehicle | Placebo Comparator | Topical preservative-free vehicle (Placebo) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SURF-201 | Drug | One drop twice daily (BID) in the study eye for 16 days. |
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| Measure | Description | Time Frame |
|---|---|---|
| Anterior Chamber Cell (ACC) Grade: Number of Participants Achieving an ACC Grade of 0 | The Investigator used a slit lamp biomicroscope to assess ACCs in the study (surgery) eye. ACC counts were graded as follows: ACC Grade 0 = 0 cells were seen ACC Grade higher than 0 = 1 or more cells were seen | Day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Post-surgical Ocular Pain Score: Number of Participants Achieving an Ocular Pain Score of 0 | Ocular pain was assessed and graded by the participants using the Visual Analog Scale (VAS). The VAS was scored from 0 to 100 using a mark on the 100 mm line (0=absent [no pain], 100=maximum [severe pain]). | Day 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kamran Hosseini, MD, PhD | Surface Ophthalmics, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inland Eye Specialists | Hemet | California | 92545 | United States | ||
| LoBue Laser and Eye Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37564159 | Background | Hosseini K, Gollamudi S, Reiser H, Walters T, Lindstrom RL. 0.2% Betamethasone Sodium Phosphate: A Multicenter, Randomized, Double-Masked Study to Compare Its Ocular Safety, Tolerability, and Efficacy to Vehicle in Cataract Surgery Subjects. Clin Ophthalmol. 2023 Aug 5;17:2219-2230. doi: 10.2147/OPTH.S419857. eCollection 2023. |
| Label | URL |
|---|---|
| 0.2% Betamethasone Sodium Phosphate: A Multicenter, Randomized, Double-Masked Study to Compare Its Ocular Safety, Tolerability, and Efficacy to Vehicle in Cataract Surgery Subjects. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | SURF-201 | 0.2% topical preservative-free corticosteroid solution (0.2% betamethasone sodium phosphate) SURF-201: One drop twice daily (BID) in the study eye for 16 days. |
| FG001 | Vehicle |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 9, 2020 |
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| Placebo | Drug | One drop twice daily (BID) in the study eye for 16 days. |
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| Post-surgical Ocular Pain Score: Number of Participants Achieving an Ocular Pain Score of 0 |
Ocular pain was assessed and graded by the participants using the Visual Analog Scale (VAS). The VAS was scored from 0 to 100 using a mark on the 100 mm line (0=absent [no pain], 100=maximum [severe pain]). |
| Day 8 |
| Post-surgical Ocular Pain Score: Number of Participants Achieving an Ocular Pain Score of 0 | Ocular pain was assessed and graded by the participants using the Visual Analog Scale (VAS). The VAS was scored from 0 to 100 using a mark on the 100 mm line (0=absent [no pain], 100=maximum [severe pain]). | Day 15 |
| Post-surgical Ocular Pain Score: Number of Participants Achieving an Ocular Pain Score of 0 | Ocular pain was assessed and graded by the participants using the Visual Analog Scale (VAS). The VAS was scored from 0 to 100 using a mark on the 100 mm line (0=absent [no pain], 100=maximum [severe pain]). | Day 22 |
| Post-surgical Ocular Pain Score: Number of Participants Achieving an Ocular Pain Score of 0 | Ocular pain was assessed and graded by the participants using the Visual Analog Scale (VAS). The VAS was scored from 0 to 100 using a mark on the 100 mm line (0=absent [no pain], 100=maximum [severe pain]). | Day 32 |
| Murrieta |
| California |
| 92562 |
| United States |
| Hernando Eye Institute | Brooksville | Florida | 34613 | United States |
| Levenson Eye Associates | Jacksonville | Florida | 32204 | United States |
| East Florida Eye Institute | Stuart | Florida | 34994 | United States |
| Alterman, Modi & Wolter | Poughkeepsie | New York | 12603 | United States |
| Eye Care Specialists | Kingston | Pennsylvania | 18704 | United States |
| VRF Eye Specialty Group | Memphis | Tennessee | 38120 | United States |
| Texan Eye Care, PA - Keystone Research, Ltd. | Austin | Texas | 78731 | United States |
| R and R Eye Research, LLC | San Antonio | Texas | 78229 | United States |
Topical preservative-free vehicle (Placebo)
Placebo: One drop twice daily (BID) in the study eye for 16 days.
| COMPLETED |
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| NOT COMPLETED |
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Randomized participants who underwent routine uncomplicated cataract surgery.
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| ID | Title | Description |
|---|---|---|
| BG000 | SURF-201 | 0.2% topical preservative-free corticosteroid solution (0.2% betamethasone sodium phosphate) SURF-201: One drop twice daily (BID) in the study eye for 16 days. |
| BG001 | Vehicle | Topical preservative-free vehicle (Placebo) Placebo: One drop twice daily (BID) in the study eye for 16 days. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Anterior Chamber Cell (ACC) Grade at Baseline | Number of participants with a baseline ACC Grade of 0 (i.e., no ACCs seen) | Count of Participants | Participants |
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| Ocular Pain Score at Baseline | Number of participants with a baseline Ocular Pain Score of 0 (no pain) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Anterior Chamber Cell (ACC) Grade: Number of Participants Achieving an ACC Grade of 0 | The Investigator used a slit lamp biomicroscope to assess ACCs in the study (surgery) eye. ACC counts were graded as follows: ACC Grade 0 = 0 cells were seen ACC Grade higher than 0 = 1 or more cells were seen | Randomized participants who had uncomplicated cataract surgery. Missing values were imputed using last observation carried forward (LOCF). LOCF is a common statistical approach to the analysis of longitudinal repeated measures where some follow-up (FU) observations may be missing. In a LOCF analysis, a missing FU value is replaced by (imputed as) that participant's previously observed value. The combination of the observed and imputed data is then analyzed as if there were no missing data. | Posted | Count of Participants | Participants | Day 15 |
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| Secondary | Post-surgical Ocular Pain Score: Number of Participants Achieving an Ocular Pain Score of 0 | Ocular pain was assessed and graded by the participants using the Visual Analog Scale (VAS). The VAS was scored from 0 to 100 using a mark on the 100 mm line (0=absent [no pain], 100=maximum [severe pain]). | Randomized participants who underwent routine uncomplicated cataract surgery and had no missing assessments. | Posted | Count of Participants | Participants | Day 1 |
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| Secondary | Post-surgical Ocular Pain Score: Number of Participants Achieving an Ocular Pain Score of 0 | Ocular pain was assessed and graded by the participants using the Visual Analog Scale (VAS). The VAS was scored from 0 to 100 using a mark on the 100 mm line (0=absent [no pain], 100=maximum [severe pain]). | Randomized participants who underwent routine uncomplicated cataract surgery and had no missing assessments. | Posted | Count of Participants | Participants | Day 8 |
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| Secondary | Post-surgical Ocular Pain Score: Number of Participants Achieving an Ocular Pain Score of 0 | Ocular pain was assessed and graded by the participants using the Visual Analog Scale (VAS). The VAS was scored from 0 to 100 using a mark on the 100 mm line (0=absent [no pain], 100=maximum [severe pain]). | Randomized participants who underwent routine uncomplicated cataract surgery and had no missing assessments. | Posted | Count of Participants | Participants | Day 15 |
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| Secondary | Post-surgical Ocular Pain Score: Number of Participants Achieving an Ocular Pain Score of 0 | Ocular pain was assessed and graded by the participants using the Visual Analog Scale (VAS). The VAS was scored from 0 to 100 using a mark on the 100 mm line (0=absent [no pain], 100=maximum [severe pain]). | Posted | Count of Participants | Participants | Day 22 |
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| Secondary | Post-surgical Ocular Pain Score: Number of Participants Achieving an Ocular Pain Score of 0 | Ocular pain was assessed and graded by the participants using the Visual Analog Scale (VAS). The VAS was scored from 0 to 100 using a mark on the 100 mm line (0=absent [no pain], 100=maximum [severe pain]). | Randomized participants who underwent routine uncomplicated cataract surgery and had no missing VAS assessments. | Posted | Count of Participants | Participants | Day 32 |
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Overall study period
Adverse events were collected from each participant's signature of informed consent at Screening through Day 32 (completion of the study) or early withdrawal.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SURF-201 | 0.2% topical preservative-free corticosteroid solution (0.2% betamethasone sodium phosphate) SURF-201: One drop twice daily (BID) in the study eye for 16 days. | 0 | 40 | 3 | 40 | 26 | 40 |
| EG001 | Vehicle | Topical preservative-free vehicle (Placebo) Placebo: One drop twice daily (BID) in the study eye for 16 days. | 0 | 43 | 0 | 43 | 23 | 43 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cystoid macular edema | Eye disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Posterior caple rupture | Eye disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Intraocular pressure increased | Investigations | MedDRA Version 23.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Visual acuity reduced | Eye disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Eye inflammation | Eye disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Posterior capsule opacification | Eye disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Eye pain | Eye disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Corneal edema | Eye disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Photophobia | Eye disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Conjunctival hyperemia | Eye disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Iritis | Eye disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Vitreous detachment | Eye disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Eye irritation | Eye disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Vitreous floaters | Eye disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Intraocular pressure increased | Investigations | MedDRA Version 23.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| VP, Clinical Operations | Surface Ophthalmics Inc. | (925) 494-3660 | 18 | cbaenziger@surfaceophthalmics.com |
| Sep 28, 2023 |
| Prot_SAP_000.pdf |
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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