A Multicenter, Randomized, Double-Masked Study To Evaluate The Safety, Tolerability, And Efficacy Of SURF-100 Ophthalmic Solution (A Mycophenolic Acid/Betamethasone Sodium Phosphate Combination) In Subjects With Dry Eye Disease
Overview
- Phase
- Phase 2
- Intervention
- SURF-100 (Combination of 0.3% Mycophenolic Acid and 0.01% Betamethasone Sodium Phosphate)
- Conditions
- Dry Eye Disease
- Sponsor
- Surface Ophthalmics, Inc.
- Enrollment
- 349
- Locations
- 40
- Primary Endpoint
- University of North Carolina Dry Eye Management Scale (UNC DEMS) Responder Analysis
- Status
- Completed
- Last Updated
- 11 months ago
Overview
Brief Summary
SURF-100 is being studied for the treatment of dry eye disease. SURF-100 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-100 works to treat dry eye and what potential side effects there are, and to compare it with Vehicle (placebo), 0.1% mycophenolic acid (MPA) in Vehicle, 0.3% MPA in Vehicle, 0.01% betamethasone phosphate (BSP) in Vehicle, Restasis and Xiidra. This study will involve about 280-350 study participants age 18 and older at about 40 different research sites in the United States.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Adults at least 18 years of age at the time of the Screening visit.
- •Willing and able to read, sign, and date the informed consent form (ICF) after the nature of the study has been explained and any questions have been answered, and prior to initiation of any study procedures or exams.
- •Willing and able to comply with all study procedures and attend all study visits.
- •Willing to suspend use of tear substitutes at least 72 hours prior to Visit 2 (Day 0) through Visit 7 (Day 98).
- •Best corrected visual acuity (BCVA) of 0.7 log of the minimum angle of resolution (logMAR) or better (Snellen equivalent score of 20/100 or better) in each eye at Visit 1 (Day -14 to Day 0).
- •Subject-reported history of dry eye in both eyes.
- •Meeting ALL of the following criteria in the same eye at Visit 1 (Day -14 to Day 0) and meeting ALL of the following criteria in the same eye at Visit 2 (Day 0) if Visit 2 is performed \>5 days after Visit 1:
- •Minimum score of greater than or equal to 5 but less than or equal to 9 on UNC DEMS questionnaire.
- •Schirmer Tear Test (with anesthesia) equal to or less than 10 mm, but more than 1 mm.
- •TBUT: Equal to or less than 5 seconds
Exclusion Criteria
- •Contraindications or known hypersensitivity to the study drug(s), including RESTASIS or XIIDRA, or their components.
- •Subjects who are employees or immediate family members of employees at the investigational site.
- •Subjects who are members of the same household.
- •Any ocular condition that, in the opinion of the investigator, may affect study parameters including, but not limited to, lid margin disorders (e.g., blepharitis including staphylococcal, demodex, or seborrheic; excessive lid laxity, floppy eyelid syndrome, ectropion, entropion), advanced conjunctivochalasis, Salzmann's nodular degeneration, and asthenopia-related conditions, allergic conjunctivitis, glaucoma, diabetic retinopathy, follicular conjunctivitis, iritis, uveitis, wet-exudative age-related macular degeneration, retinal vein occlusion, and/or active ocular inflammation.
- •Any condition that could affect trigeminal nerve function including facial or ocular Herpes Zoster/Shingle, a stroke or nerve palsy affecting the eye(s).
- •Use of any topical medication and/or antibiotics for the treatment of blepharitis or meibomian gland disease in either eye within 14 days prior to Visit 2 (Day 0).
- •Active or history of ocular herpes or any other ocular infection in either eye within the last 30 days prior to Visit 1 (Day -14 to Day 0).
- •Unwilling to avoid wearing contact lenses for 7 days prior to Randomization (Visit 2, Day 0) and for the duration of the study period (through Visit 7, Day 98).
- •Positive urine pregnancy test at Screening, nursing an infant or planning to become pregnant during the study.
- •Any blood donation or significant loss of blood within 56 days of Visit 1 (Day -14 to Day 0).
Arms & Interventions
SURF-100 (a combination of 0.3% Mycophenolic Acid and 0.01% Betamethasone Sodium Phosphate)
One drop in the study eye (and fellow eye, if applicable) twice daily for 84 days
Intervention: SURF-100 (Combination of 0.3% Mycophenolic Acid and 0.01% Betamethasone Sodium Phosphate)
Mycophenolic Acid 0.1%
One drop in the study eye (and fellow eye, if applicable) twice daily for 84 days.
Intervention: Mycophenolic Acid 0.1%
Mycophenolic Acid 0.3%
One drop in the study eye (and fellow eye, if applicable) twice daily for 84 days.
Intervention: Mycophenolic Acid 0.3%
Betamethasone Sodium Phosphate 0.01%
One drop in the study eye (and fellow eye, if applicable) twice daily for 84 days.
Intervention: Betamethasone Sodium Phosphate 0.01%
Cyclosporine 0.05% Ophthalmic Emulsion
One drop in the study eye (and fellow eye, if applicable) twice daily for 84 days
Intervention: Cyclosporine 0.05% Ophthalmic Emulsion
Lifitegrast 5% Ophthalmic Solution
One drop in the study eye (and fellow eye, if applicable) twice daily for 84 days
Intervention: Lifitegrast 5% Ophthalmic Solution
Outcomes
Primary Outcomes
University of North Carolina Dry Eye Management Scale (UNC DEMS) Responder Analysis
Time Frame: Baseline and Day 84
The UNC DEMS scale is a participant-specific 10-point scale with a minimum score of 1 (\[1-2\] My symptoms are not a problem. My dry eye does not affect my daily life at all) and a maximum score of 10 (\[9-10\] my symptoms are severe and I need immediate medical care. My dry eye greatly affects my daily life). Participants with a 10% or higher reduction in UNC DEMS score from baseline were defined as responders, and response rates were summarized by treatment group.
Secondary Outcomes
- Tear Break Up Time (TBUT), Study Eye(Baseline and Day 84)
- Schirmer Tear Test Score, Study Eye(Baseline and Day 84)