Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of the research is to see if Upneeq ( oxymetazoline 0.1% ophthalmic solution) has an effect on eyelid position, eye redness, or patient-perceived appearance of the eyes.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Upneeq Group | Experimental | Participants in this group will receive a one-time dosing of oxymetazoline hydrochloride 0.1% (1 drop applied to ocular surface of each eye of patients in the treatment group) |
|
| Control Group | Sham Comparator | Participants in this group will receive a one-time dosing of balanced saline solution (1 drop applied to ocular surface of each eye of patients in the control group) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxymetazoline hydrochloride 0.1% ophthalmic solution | Drug | One drop of Upneeq (Oxymetazoline hydrochloride 0.1% ophthalmic solution) will be applied to the ocular surface of each eye. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Palpebral Fissure Height | Palpebral fissure height will be calculated from the sum of marginal reflex distance 1 and 2 measured from the photograph by Ipad software and recorded by investigators before and after drop instillation. | Baseline, Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Eye Redness as Measured by the Validated Bulbar Redness Grading Scale | Scoring of ocular redness from clinical photographs will be performed by investigators on a 10 - 100 unit scale as compared to standardized reference photographs per the Validated Bulbar Redness grading scale (10 = minimal redness, 100 = very red) before and after drop instillation. Higher score indicates more redness. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Wendy W. Lee, MD | University of Miami Bascom Palmer Eye Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami Bascom Palmer Eye Institute | Miami | Florida | 33136 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36996503 | Derived | Shoji MK, Markatia Z, Ameli K, Bayaraa M, Clauss KD, Ugradar S, Lee WW. The effects of topical oxymetazoline on eyelid position, eye redness, and patient-reported eye appearance: A randomized controlled trial. J Plast Reconstr Aesthet Surg. 2023 May;80:66-74. doi: 10.1016/j.bjps.2023.02.006. Epub 2023 Feb 9. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Upneeq Group | Participants in this group will receive a one-time dosing of oxymetazoline hydrochloride 0.1% (1 drop applied to ocular surface of each eye of patients in the treatment group) Oxymetazoline hydrochloride 0.1% ophthalmic solution: One drop of Upneeq (Oxymetazoline hydrochloride 0.1% ophthalmic solution) will be applied to the ocular surface of each eye. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| 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 | Mar 29, 2023 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Placebo | Drug | One drop of placebo (balanced saline solution) will be applied to the ocular surface of each eye. |
|
|
| Baseline, Day 1 |
| Change in Patient-reported Eye Appearance - FACE-Q Eye Appearance | Change in patient-reported eye appearance will be assessed by patient completion of the FACE-Q Eye Module Survey assessing overall eye appearance with a sum score of 7 (worst) to 28 (best) at baseline and after drop administration. Higher score indicates a higher level of satisfaction with eye appearance. | Baseline, Day 1 |
| Change in Patient-reported Eye Appearance - FACE-Q Upper Eyelid Appearance | Change in patient-reported upper eyelid appearance will be assessed by patient completion of the FACE-Q Eye Module Survey assessing overall upper eyelid appearance with a sum score of 7 (worst) to 28 (best) at baseline and after drop administration. Higher score indicates a higher level of satisfaction with upper eyelid appearance. | Baseline, Day 1 |
| FG001 |
| Control Group |
Participants in this group will receive a one-time dosing of balanced saline solution (1 drop applied to ocular surface of each eye of patients in the control group) Placebo: One drop of placebo (balanced saline solution) will be applied to the ocular surface of each eye. |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Upneeq Group | Participants in this group will receive a one-time dosing of oxymetazoline hydrochloride 0.1% (1 drop applied to ocular surface of each eye of patients in the treatment group) Oxymetazoline hydrochloride 0.1% ophthalmic solution: One drop of Upneeq (Oxymetazoline hydrochloride 0.1% ophthalmic solution) will be applied to the ocular surface of each eye. |
| BG001 | Control Group | Participants in this group will receive a one-time dosing of balanced saline solution (1 drop applied to ocular surface of each eye of patients in the control group) Placebo: One drop of placebo (balanced saline solution) will be applied to the ocular surface of each eye. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Palpebral Fissure | Mean | Standard Deviation | mm |
| |||||||||||||||
| Eye Redness | Scoring of ocular redness from clinical photographs will be performed by investigators on a 10 - 100 unit scale as compared to standardized reference photographs per the Validated Bulbar Redness grading scale (10 = minimal redness, 100 = very red) before and after drop instillation. Higher score indicates more redness. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| FACE-Q Eye Appearance | One patient did not complete FACE-Q survey in control group | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| FACE-Q Upper Eyelid Appearance | One patient did not complete FACE-Q survey in control group | Mean | Standard Deviation | units on a scale |
|
| 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 | Change in Palpebral Fissure Height | Palpebral fissure height will be calculated from the sum of marginal reflex distance 1 and 2 measured from the photograph by Ipad software and recorded by investigators before and after drop instillation. | Posted | Mean | Standard Deviation | mm | Baseline, Day 1 |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Change in Eye Redness as Measured by the Validated Bulbar Redness Grading Scale | Scoring of ocular redness from clinical photographs will be performed by investigators on a 10 - 100 unit scale as compared to standardized reference photographs per the Validated Bulbar Redness grading scale (10 = minimal redness, 100 = very red) before and after drop instillation. Higher score indicates more redness. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Day 1 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Change in Patient-reported Eye Appearance - FACE-Q Eye Appearance | Change in patient-reported eye appearance will be assessed by patient completion of the FACE-Q Eye Module Survey assessing overall eye appearance with a sum score of 7 (worst) to 28 (best) at baseline and after drop administration. Higher score indicates a higher level of satisfaction with eye appearance. | One control patient declined completion of FACE-Q survey. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Day 1 |
|
| |||||||||||||||||||||||||||||
| Secondary | Change in Patient-reported Eye Appearance - FACE-Q Upper Eyelid Appearance | Change in patient-reported upper eyelid appearance will be assessed by patient completion of the FACE-Q Eye Module Survey assessing overall upper eyelid appearance with a sum score of 7 (worst) to 28 (best) at baseline and after drop administration. Higher score indicates a higher level of satisfaction with upper eyelid appearance. | One control patient declined completion of FACE-Q survey | Posted | Mean | Standard Deviation | score on a scale | Baseline, Day 1 |
|
1 day: this study was a single time-instillation of a topical temporary medication
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Upneeq Group | Participants in this group will receive a one-time dosing of oxymetazoline hydrochloride 0.1% (1 drop applied to ocular surface of each eye of patients in the treatment group) Oxymetazoline hydrochloride 0.1% ophthalmic solution: One drop of Upneeq (Oxymetazoline hydrochloride 0.1% ophthalmic solution) will be applied to the ocular surface of each eye. | 0 | 57 | 0 | 57 | 7 | 57 |
| EG001 | Control Group | Participants in this group will receive a one-time dosing of balanced saline solution (1 drop applied to ocular surface of each eye of patients in the control group) Placebo: One drop of placebo (balanced saline solution) will be applied to the ocular surface of each eye. | 0 | 57 | 0 | 57 | 5 | 57 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry eye | Eye disorders | Non-systematic Assessment |
| ||
| Headache | General disorders | Non-systematic Assessment |
| ||
| Eyelid heaviness | Eye disorders | Non-systematic Assessment |
| ||
| Light Sensitivity | Eye disorders | Non-systematic Assessment |
| ||
| Temporary Blurry Vision | Eye disorders | Non-systematic Assessment | Lasted 10 minutes after drop instillation |
| |
| Dizziness | General disorders | Non-systematic Assessment | Self-resolving dizziness |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Wendy W. Lee MD | Bascom Palmer Eye Institute | 305-243-6434 | wlee@med.miami.edu |
| Mar 29, 2023 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D001763 | Blepharoptosis |
| D003231 | Conjunctivitis |
| D005132 | Eye Manifestations |
| ID | Term |
|---|---|
| D005141 | Eyelid Diseases |
| D005128 | Eye Diseases |
| D003229 | Conjunctival Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D010109 | Oxymetazoline |
| D009883 | Ophthalmic Solutions |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D020313 | Specialty Uses of Chemicals |
Not provided
Not provided
|
|
|
|
|
|
|
|
| Counts |
|---|
| Participants |
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|