The Study Evaluating the Efficacy and Safety of OK-101 in Subjects With Dry Eye Disease

NCT05759208 | Completed Phase 2 FDA Drug

• 1 other identifier: 22-110-0018
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 6

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.

Conditions

Dry Eye Disease

Outcome Measures

Primary Outcomes (2)

• Total Corneal Fluorescein Staining

  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.

  85 days

• Ocular Discomfort Score

  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.

  85 days

Secondary Outcomes (4)

• Fluorescein Staining by Region

  85 days

• Lissamine Green Staining by Region

  85 days

• Conjunctival Redness

  85 days

• Schirmer's Test

  85 days

Study Arms (3)

Placebo

EXPERIMENTAL

OK-101 Placebo Ophthalmic Solution (vehicle): 1 drop BID in each eye (N = \~80)

Drug: Placebo

Low Dose OK-101

EXPERIMENTAL

0.05% OK-101 Ophthalmic Solution: 1 drop BID in each eye (N = \~80)

Drug: OK-101

High-Dose OK-101

EXPERIMENTAL

0.1% OK-101 Ophthalmic Solution: 1 drop BID in each eye (N = \~80)

Drug: OK-101

Interventions

OK-101 DRUG

Ophthalmic Solution

High-Dose OK-101; Low Dose OK-101

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Have a conjunctival redness score ≥ 1 according to the Ora Calibra® Conjunctival Redness for Dry Eye Scale in at least one eye at Visits 1 and 2 pre- CAE;
• Demonstrate in the same eye(s) a response to the CAE at Visits 1 and 2 as defined by:
• Having at least a ≥1 point increase in fluorescein staining in the inferior region in at least one eye following CAE® exposure;
• Reporting an Ocular Discomfort score ≥3 at 2 or more consecutive time points in at least one eye during CAE® exposure (if a subject has an Ocular Discomfort rating of 3 at time = 0 for an eye, s/he must report an Ocular Discomfort rating of 4 for two consecutive measurements for that eye). Note: a subject cannot have an Ocular Discomfort score of 4 at time = 0);
• Have at least one eye, the same eye, satisfy all criteria for 8, 9, 10, 11 and 12 above;

You may not qualify if:

• 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
• Oral aspirin or aspirin-containing products allowed if dose has been stable over past 30 days prior to Visit 1 and no change in dose is anticipated during the study period
• Corticosteroids or mast cell stabilizers (including ocular): 14 days prior to Visit 1
• Any medication (oral or topical) known to cause ocular drying that has not been administered as a stable dose for at least 30 days prior to Visit 1 and during the study
• Neurostimulators: 30 days prior to Visit 1
• Current use or planned use of Prokera® during study conduct or within 30 days prior to Visit 1

Sponsors & Collaborators

• Okyo Pharma Ltd: lead
• ORA, Inc.: collaborator

Study Sites (6)

Eye Research Foundation

Newport Beach, California, 92663, United States

Location

Vision Institute

Colorado Springs, Colorado, 80907, United States

Location

Butchertown clinical Trials

Louisville, Kentucky, 40206, United States

Location

Andover Eye Associates

Andover, Massachusetts, 01810, United States

Location

Core Inc.

Shelby, North Carolina, 28150, United States

Location

Total Eye Care, PA

Memphis, Tennessee, 38119, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Raj Patil, PhD

  Okyo Pharma Ltd

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double mask and placebo-controlled
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2023
• First Posted: March 8, 2023
• Study Start: April 28, 2023
• Primary Completion: December 15, 2023
• Study Completion: December 15, 2023
• Last Updated: February 9, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)