A Phase 2, Multi-center, Randomized, Double-Masked and Placebo-Controlled Study Evaluating the Efficacy and Safety of OK-101 Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye Disease
Overview
- Phase
- Phase 2
- Intervention
- OK-101
- Conditions
- Dry Eye Disease
- Sponsor
- Okyo Pharma Ltd
- Enrollment
- 240
- Locations
- 6
- Primary Endpoint
- Total Corneal Fluorescein Staining
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The objective of this study is to compare the safety and efficacy of OK-101 Ophthalmic Solution to placebo for the treatment of the signs and symptoms of dry eye.
Detailed Description
Subjects eligible to be randomized will receive either OK-101 or placebo to be administered bilaterally twice daily (BID) for 12 weeks (from Visit 2 to Visit 5). During a 14-day study run-in period (for the purpose of subject selection) prior to randomization, all subjects will receive Placebo Ophthalmic Solution (vehicle) bilaterally BID.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Be at least 18 years of age;
- •Provide written informed consent;
- •Be willing and able to comply with all study procedures;
- •Have a patient-reported history of dry eye for at least 6 months prior to Visit 1;
- •Have a history of use or desire to use eye drops for dry eye symptoms within 6 months of Visit 1;
- •Have a best corrected visual acuity (BCVA) of 0.7 logarithm of the minimum angle of resolution (logMAR) or better (Snellen equivalent score of 20/100 or better) in each eye at Visit 1;
- •Report a score of ≥ 2 according to the Ora Calibra® Ocular Discomfort \& 4-Symptom Questionnaire in at least one of the dry eye symptoms at Visits 1 and 2;
- •Have a Schirmer's Test score of ≤ 10 mm and ≥ 1 mm at Visits 1 and 2;
- •Have a corneal fluorescein staining score of ≥ 2 in at least one region according to the Ora Calibra® Corneal and Conjunctival Staining Scale for Grading of Fluorescein Staining in at least one region in one eye at Visits 1 and 2 and a central score ≥ 1 in the same eye;
- •Have a total lissamine green conjunctival score of ≥ 2, based on the sum of the temporal and nasal regions pre-CAE® at Visits 1 and 2;
Exclusion Criteria
- •Have any clinically significant slit lamp findings at Visit 1 that may include active blepharitis, meibomian gland dysfunction, ocular rosacea, lid margin inflammation, or active ocular allergies that require therapeutic treatment, or currently using tetracyclines (e.g., doxycycline, minocycline, tetracycline) and/or in the opinion of the investigator may interfere with study parameters;
- •Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1;
- •Have worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses during the study;
- •Have previously had laser-assisted in situ keratomileusis (LASIK) surgery, Photorefractive keratectomy (PRK), or small incision lenticule extraction (SMILE) within the last 12 months;
- •Have used Restasis®, Xiidra®, Cequa®, Tyrvaya®, serum tears, generic cyclosporine A, and EYSUVIS® within 30 days of Visit 1;
- •Have had any ocular and/or lid surgeries in the past 6 months or have any planned ocular and/or lid surgeries over the study period;
- •Any use of Lipiflow, thermopulsation, Meibomian gland expression or intense pulsed light treatment within 6 months of visit 1
- •Be using or anticipate using temporary punctal plugs during the study that have not been stable within 30 days of Visit 1 or have permanent punctal plugs or had surgical punctal occlusion;
- •Be currently taking any topical ophthalmic prescription (including medications for glaucoma) or over-the-counter solutions, artificial tears, gels or scrubs, and cannot discontinue these medications for the duration of the trial (excluding medications allowed for the conduct of the study); the respective wash-out periods are required for the following medications:
- •Antihistamines (including ocular): 72 hours prior to Visit 1
Arms & Interventions
Low Dose OK-101
0.05% OK-101 Ophthalmic Solution: 1 drop BID in each eye (N = \~80)
Intervention: OK-101
Placebo
OK-101 Placebo Ophthalmic Solution (vehicle): 1 drop BID in each eye (N = \~80)
Intervention: Placebo
High-Dose OK-101
0.1% OK-101 Ophthalmic Solution: 1 drop BID in each eye (N = \~80)
Intervention: OK-101
Outcomes
Primary Outcomes
Total Corneal Fluorescein Staining
Time Frame: 85 days
Total corneal fluorescein staining score of the study eye using the Ora Calibra® scale, measured by mean change from baseline (Visit 2 pre-CAE®) to Day 85 (Visit 6). Each of the 5 areas will be scored on a scale of 0 to 4 for a total minimum score of 0 to total maximum score of 20, with 0 being best and 20 being worst.
Ocular Discomfort Score
Time Frame: 85 days
Ocular discomfort score of both eyes using the Ora Calibra® scale, measured by mean change from baseline (Visit 2 pre-CAE®) to Day 85 (Visit 6). Each eye will be scored separately on a scale from 1 to 4, with 1 being best and 4 being worst.
Secondary Outcomes
- Schirmer's Test(85 days)
- Fluorescein Staining by Region(85 days)
- Conjunctival Redness(85 days)
- Lissamine Green Staining by Region(85 days)