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Dry Eye DiseasePhase 2NCT05759208

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

A Phase 2 study testing OK-101 in people with Dry Eye Disease, run by Okyo Pharma Ltd at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Dry Eye Disease
What is being tested?
OK-101
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
240 participants
Where
6 sitesUnited States
Study dates
28 Apr 2023to 15 Dec 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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;
  • A negative urine pregnancy test if female of childbearing potential (those who are not surgically sterilized [bilateral tubal ligation, hysterectomy or bilateral oophorectomy] or post- menopausal [12 months after last menses]) and must use adequate birth control through the study period. For non-sexually active females, abstinence may be regarded as an adequate method of birth control.

Who cannot join

  • 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;
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  • 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
  • All other topical ophthalmic preparations (including artificial tear substitutes) other than the study drops: 72 hours prior to Visit 1
  • Have an uncontrolled systemic disease;
  • Be a woman who is pregnant, nursing, or planning a pregnancy;
  • Be unwilling to submit a urine pregnancy test at Visit 1 and Visit 6 (or early termination visit) if of childbearing potential. Non-childbearing potential is defined as a woman who is permanently sterilized (e.g., has had a hysterectomy or tubal ligation), or is postmenopausal (without menses for 12 consecutive months);
  • Be a woman of childbearing potential who is not using an acceptable means of birth control; acceptable methods of contraception include: hormonal - oral, implantable, injectable, or transdermal contraceptives; mechanical - spermicide in conjunction with a barrier such as a diaphragm or condom; intrauterine device; or surgical sterilization of partner. For non-sexually active females, abstinence may be regarded as an adequate method of birth control; however, if the subject becomes sexually active during the study, she must agree to use adequate birth control as defined above for the remainder of the study;
  • Have a known allergy and/or sensitivity to the test article or its components;
  • Have a condition or be in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study;
  • Be currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days of Visit 1;

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • Andover Eye Associates

    Andover, Massachusetts, 01810

  • Vision Institute

    Colorado Springs, Colorado, 80907

  • Butchertown clinical Trials

    Louisville, Kentucky, 40206

  • Total Eye Care, PA

    Memphis, Tennessee, 38119

  • Eye Research Foundation

    Newport Beach, California, 92663

  • Core Inc.

    Shelby, North Carolina, 28150

Other trials in United States

About this study

Official title: 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

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.

Read the 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.

Conditions
Dry Eye Disease
Being tested
OK-101, Placebo
Medical subject headings
Dry Eye Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OK-101Drug

    Ophthalmic Solution

  • PlaceboDrug

    Placebo

Study groups in NCT05759208
Study groupRoleWhat they receive
PlaceboExperimentalOK-101 Placebo Ophthalmic Solution (vehicle): 1 drop BID in each eye (N = ~80)
Receives: Drug: Placebo
Low Dose OK-101Experimental0.05% OK-101 Ophthalmic Solution: 1 drop BID in each eye (N = ~80)
Receives: Drug: OK-101
High-Dose OK-101Experimental0.1% OK-101 Ophthalmic Solution: 1 drop BID in each eye (N = ~80)
Receives: Drug: OK-101

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 85 days

  2. 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.

    Measured: 85 days

Secondary outcomes (4)

  1. Fluorescein Staining by Region

    Fluorescein staining by region: central, superior, inferior, temporal, nasal, corneal sum, conjunctival sum, and total staining of each eye using the Ora Calibra® scale. 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

    Measured: 85 days

  2. Lissamine Green Staining by Region

    Lissamine green staining by region: central, superior, inferior, temporal, nasal, corneal sum, conjunctival sum, and total staining of each eye using the Ora Calibra® scale. 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.

    Measured: 85 days

  3. Conjunctival Redness

    Conjunctival redness of each eye using the Ora Calibra® scale. Each eye will be graded on a scale of 0 to 4, with 0 being best and 4 being worst.

    Measured: 85 days

  4. Schirmer's Test

    Schirmer's Test of each eye

    Measured: 85 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Mar 2023
  2. Study start28 Apr 2023
  3. Primary completion15 Dec 2023
  4. Study completion15 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
240 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05759208
Sponsor's protocol ID
22-110-0018
Status last verified
Feb 2024
First submitted
23 Feb 2023
Last updated
9 Feb 2024
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing OK-101 in people with Dry Eye Disease, run by Okyo Pharma Ltd at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total Corneal Fluorescein Staining (time frame: 85 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05759208.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2024.

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