Back to resultsThe Effect of Upneeq (Oxymetazoline Hydrochloride 0.1%) on Eyelid Position, Eye Redness, and Eye Appearance
Primary Purpose
Ptosis, Eyelid, Conjunctiva Inflamed, Eye Manifestations
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Oxymetazoline hydrochloride 0.1% ophthalmic solution
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Ptosis, Eyelid
Eligibility Criteria
Inclusion Criteria:
- Adults age 18 and above able to provide informed consent to participate
- Subject with stable ocular health, defined as no ocular conditions requiring ongoing topical therapy or recent surgical intervention
Exclusion Criteria:
- Adults unable to consent
- Individuals less than 18 years of age
- Prisoners
- Pregnant women.
- Known contradictions or sensitivities to study medication (oxymetazoline)
- Ocular surgery within the past 3 months or refractive surgery within the past six months
- Grossly abnormal lid margins, anatomical abnormalities, previous eyelid or orbital surgery
- Variable ptosis or eyelid position (e.g., myasthenia gravis, thyroid eye disease, or blepharospasm)
- Any ocular or systemic condition that, in the opinion of the investigator, would confound study data, interfere with the subject's study participation, or affected the subject's safety or trial parameters
- Presence of an active ocular infection
- Prior (within 5 days of beginning study treatment) use of eye whiteners (eg, vasoconstrictors), decongestants, antihistamines (including over the counter and herbal topical ophthalmic medications), phenylephrine dilating drops, any other topical ophthalmic agents
- Inability to sit comfortably for 15 - 30 minutes
Sites / Locations
- University of Miami Bascom Palmer Eye Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Upneeq Group
Control Group
Arm Description
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)
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)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04831047
Brief Title
The Effect of Upneeq (Oxymetazoline Hydrochloride 0.1%) on Eyelid Position, Eye Redness, and Eye Appearance
Official Title
The Effect of Upneeq (Oxymetazoline Hydrochloride 0.1%) on Palpebral Fissure Height, Eye Redness, and Patient-reported Eye Appearance
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
June 8, 2021 (Actual)
Primary Completion Date
April 1, 2022 (Actual)
Study Completion Date
April 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ptosis, Eyelid, Conjunctiva Inflamed, Eye Manifestations
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
114 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Upneeq Group
Arm Type
Experimental
Arm Description
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)
Arm Title
Control Group
Arm Type
Sham Comparator
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
Oxymetazoline hydrochloride 0.1% ophthalmic solution
Other Intervention Name(s)
Upneeq
Intervention Description
One drop of Upneeq (Oxymetazoline hydrochloride 0.1% ophthalmic solution) will be applied to the ocular surface of each eye.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Balanced saline solution
Intervention Description
One drop of placebo (balanced saline solution) will be applied to the ocular surface of each eye.
Primary Outcome Measure Information:
Title
Change in Palpebral Fissure Height
Description
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.
Time Frame
Baseline, Day 1
Secondary Outcome Measure Information:
Title
Change in Eye Redness as Measured by the Validated Bulbar Redness Grading Scale
Description
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.
Time Frame
Baseline, Day 1
Title
Change in Patient-reported Eye Appearance - FACE-Q Eye Appearance
Description
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.
Time Frame
Baseline, Day 1
Title
Change in Patient-reported Eye Appearance - FACE-Q Upper Eyelid Appearance
Description
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.
Time Frame
Baseline, Day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Adults age 18 and above able to provide informed consent to participate
Subject with stable ocular health, defined as no ocular conditions requiring ongoing topical therapy or recent surgical intervention
Exclusion Criteria:
Adults unable to consent
Individuals less than 18 years of age
Prisoners
Pregnant women.
Known contradictions or sensitivities to study medication (oxymetazoline)
Ocular surgery within the past 3 months or refractive surgery within the past six months
Grossly abnormal lid margins, anatomical abnormalities, previous eyelid or orbital surgery
Variable ptosis or eyelid position (e.g., myasthenia gravis, thyroid eye disease, or blepharospasm)
Any ocular or systemic condition that, in the opinion of the investigator, would confound study data, interfere with the subject's study participation, or affected the subject's safety or trial parameters
Presence of an active ocular infection
Prior (within 5 days of beginning study treatment) use of eye whiteners (eg, vasoconstrictors), decongestants, antihistamines (including over the counter and herbal topical ophthalmic medications), phenylephrine dilating drops, any other topical ophthalmic agents
Inability to sit comfortably for 15 - 30 minutes
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wendy W. Lee, MD
Organizational Affiliation
University of Miami Bascom Palmer Eye Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami Bascom Palmer Eye Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Upneeq (Oxymetazoline Hydrochloride 0.1%) on Eyelid Position, Eye Redness, and Eye Appearance
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