A Phase 3 interventional study of CF101 in Keratoconjunctivitis Sicca, sponsored by Can-Fite BioPharma. Completed at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-06-30.
Sponsored by Can-Fite BioPharma · Phase 3, Interventional, and Treatment
Eligible patients with dry eye will be treated with CF101 or placebo twice daily for 24 weeks. Disease activity will be assessed using evaluations of ocular surface integrity, tear production, and patient symptoms.
Patients will be randomized to receive either CF101 0.1 mg, CF101 1.0 mg, or matching placebo, given orally twice daily (BID) for 24 weeks. A Screening Period of up to 4 weeks that includes a 2-week run-in period will precede a 24-week treatment period, followed by a 2-week follow-up period.
At a Screening Visit, patients will undergo complete medical and ophthalmologic history, medication history, physical examination (including height, weight, sitting blood pressure, pulse rate and temperature), ophthalmic examination, and clinical laboratory tests. Disease activity will be assessed using fluorescein staining, Schirmer test with and without anesthesia, Ocular Surface Disease Index©, and tear break-up time.
Eligible patients will begin a 2-week run-in period during the 4-week screening period, during which time they will be instructed to discontinue use of all topical ophthalmic medications except for REFRESH TEARS® Lubricant Eye Drops. At the Baseline Visit, patients who successfully complete the 2-week run-in period and re-qualify for entry will be randomized to their assigned medication (CF101 0.1 mg, CF101 1.0 mg, or matching placebo) to be taken orally twice daily BID for 24 weeks. Patients will return for assessments and a new supply of study medication at Weeks 2, 4, 8, 12, 16, and 20; at Week 24 for a final on-treatment assessment; and at Week 26 for the 2-week off-treatment follow-up visit.
85 studies on the registry are indexed under Keratoconjunctivitis Sicca; 1 is open to participants now.
This study's enrollment of 236 is above the median of 82 across 75 interventional studies indexed under Keratoconjunctivitis Sicca.
Browse Keratoconjunctivitis Sicca studies →Can-Fite BioPharma is the lead sponsor of 22 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Have a diagnosis of moderate-to-severe Aqueous-Deficient Dry Eye (including Sjögren's Syndrome dry eye), as defined by:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects were randomized to receive CF 101 0.1mg, orally, twice daily for 24 weeks
Drug: CF101
Subjects were randomized to receive CF 101 1.0mg, orally, twice daily for 24 weeks
Drug: CF101
Subjects were randomized to receive matching placebo, orally, twice daily for 24 weeks
Drug: CF101
orally q12h
Also known as: IB-MECA
Number of Subjects Who Achieved Complete Clearing of Corneal Staining (i.e., Total Corneal FS Score = 0) at Week 24
Complete clearing of corneal staining by fluorescein staining (FS). The primary efficacy analysis was performed for 1eye (target eye), defined as the eye with the larger corneal FS value at Baseline. If both eyes had the same corneal FS value at baseline, the target eye was considered the eye with the larger central corneal staining value at Baseline. Corneal FS defined as a corneal punctate fluorescein staining score of ≥4 in either eye by the National Eye Institute evaluation scale summed over 5 areas each with a 0-3 scoring scale
Time frame: 24 weeks
Number of Subjects With Adverse Events
Determine the safety of oral CF 101 in this subject population. Adverse Events (AEs) and changes in vital signs, physical examination, clinical laboratory tests (liver, kidney, hematology, chemistry and urinalysis), electrocardiogram (ECG) findings, slit lamp and ophthalmic examination, visual acuity, and intraocular pressure measurements.
Time frame: 24 weeks
Number of Subjects Who Achieve an Increase in Schirmer Test Tearing by >9mm Over Baseline
ST wetting increase over Baseline of ≥10 mm with or without anesthesia in either eye at Week 24, using a strip of filter paper placed inside the lower eyelid
Time frame: 24 weeks
Ocular Surface Disease Index
The Ocular Surface Disease Index is assessed on a scale of 0 to 100, with higher scores representing greater disability. The subtotal score is based on 12 questions with answers ranging from 0 - "none the time," to 4 - "all of the time." The number of questions answered is totaled (0 - 12). The OSDI is calculated using the sum of subtotal scores (0-48) multiplied by 25, divided by number of questions answered (0-12). (i.e., if a participant answers all 12 questions with a severe outcome of 4, their respected OSDI = \[(4 x 12) x 25\] / 12 = \[48 x 25\] / 12 = 100) The outcome measured is the Mean Change from Baseline in Ocular Surface Disease Index at Week 24
Time frame: 24 weeks
| Milestone | CF101 0.1 mg | CF101 1 mg | Placebo |
|---|---|---|---|
| Started | 77 | 78 | 81 |
| Completed | 75 | 76 | 80 |
| Not completed | 2 | 2 | 1 |
| Withdrew: Adverse event | 2 | 2 | 1 |
Complete clearing of corneal staining by fluorescein staining (FS). The primary efficacy analysis was performed for 1eye (target eye), defined as the eye with the larger corneal FS value at Baseline. If both eyes had the same corneal FS value at baseline, the target eye was considered the eye with the larger central corneal staining value at Baseline. Corneal FS defined as a corneal punctate fluorescein staining score of ≥4 in either eye by the National Eye Institute evaluation scale summed over 5 areas each with a 0-3 scoring scale
| participants | CF101 0.1 mg | CF101 1 mg | Placebo |
|---|---|---|---|
| Complete clearing of corneal staining in target eye using NRI - YES | 15 | 13 | 21 |
| Complete clearing of corneal staining in target eye using NRI - NO | 61 | 64 | 55 |
Determine the safety of oral CF 101 in this subject population. Adverse Events (AEs) and changes in vital signs, physical examination, clinical laboratory tests (liver, kidney, hematology, chemistry and urinalysis), electrocardiogram (ECG) findings, slit lamp and ophthalmic examination, visual acuity, and intraocular pressure measurements.
| Participants | CF101 0.1 mg | CF101 1 mg | Placebo |
|---|---|---|---|
| Any AEs | 29 | 37 | 29 |
| Blood and lymphatic system disorders | 1 | 0 | 3 |
| Cardiac disorders | 4 | 6 | 6 |
| Ear and labyrinth disorders | 1 | 1 | 0 |
| Endocrine disorders | 1 | 1 | 0 |
| Eye disorders | 6 | 8 | 3 |
| Gastrointestinal disorders | 3 | 5 | 4 |
| General disorders and administration site conditions | 1 | 4 | 2 |
| Immune system disorders | 1 | 0 | 2 |
| Infections and infestations | 3 | 2 | 0 |
| Investigations | 4 | 9 | 1 |
| Musculoskeletal and connective tissue disorders | 2 | 5 | 1 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 1 | 0 | 1 |
| Nervous system disorders | 4 | 6 | 4 |
| Psychiatric disorders | 1 | 1 | 0 |
| Renal and urinary disorders | 10 | 16 | 11 |
| Reproductive system and breast disorders | 2 | 3 | 1 |
| Respiratory, thoracic and mediastinal disorders | 2 | 1 | 7 |
| Skin and subcutaneous tissue disorders | 2 | 5 | 1 |
| Vascular disorders | 2 | 4 | 4 |
ST wetting increase over Baseline of ≥10 mm with or without anesthesia in either eye at Week 24, using a strip of filter paper placed inside the lower eyelid
| Participants | CF101 0.1 mg | CF101 1 mg | Placebo |
|---|---|---|---|
| Number of subjects with ST wetting increase over baseline of >=10mm at 24 weeks | 15 | 13 | 13 |
| Number of subjects without ST wetting increase over baseline of >=10mm at 24 weeks | 61 | 64 | 63 |
The Ocular Surface Disease Index is assessed on a scale of 0 to 100, with higher scores representing greater disability. The subtotal score is based on 12 questions with answers ranging from 0 - "none the time," to 4 - "all of the time." The number of questions answered is totaled (0 - 12). The OSDI is calculated using the sum of subtotal scores (0-48) multiplied by 25, divided by number of questions answered (0-12). (i.e., if a participant answers all 12 questions with a severe outcome of 4, their respected OSDI = \[(4 x 12) x 25\] / 12 = \[48 x 25\] / 12 = 100) The outcome measured is the Mean Change from Baseline in Ocular Surface Disease Index at Week 24
| Score on a Scale - OSDI | CF101 0.1 mg | CF101 1 mg | Placebo |
|---|---|---|---|
| Ocular Surface Disease Index | -24.27 ± 17.99 | -25.63 ± 16.77 | -28.70 ± 19.08 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CF101 0.1 mg | — | 6/77 (7.8%) | 9/77 (11.7%) |
| CF101 1 mg | — | 0/78 (0%) | 13/78 (16.7%) |
| Placebo | — | 1/81 (1.2%) | 9/81 (11.1%) |
| Event | CF101 0.1 mg | CF101 1 mg | Placebo |
|---|---|---|---|
| PneumoniaRespiratory, thoracic and mediastinal disorders | 1/77 | 0/78 | 0/81 |
| Facial nerve disorderNervous system disorders | 1/77 | 0/78 | 0/81 |
| Cerebral aneurysm ruptured syphiliticNervous system disorders | 1/77 | 0/78 | 0/81 |
| Endometrial cancerReproductive system and breast disorders | 1/77 | 0/78 | 0/81 |
| Type 2 diabetes mellitusEndocrine disorders | 1/77 | 0/78 | 0/81 |
| HypertensionVascular disorders | 1/77 | 0/78 | 0/81 |
| Angina unstableCardiac disorders | 1/77 | 0/78 | 0/81 |
| Cerebrovascular accidentVascular disorders | 0/77 | 0/78 | 1/81 |
| Event | CF101 0.1 mg | CF101 1 mg | Placebo |
|---|---|---|---|
| Urinary tract infectionRenal and urinary disorders | 9/77 | 13/78 | 9/81 |
| Age, Categorical(Participants) | CF101 0.1 mg | CF101 1 mg | Placebo | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 57 | 56 | 59 | 172 |
| >=65 years | 20 | 22 | 22 | 64 |
| Age, Continuous(years) | CF101 0.1 mg | CF101 1 mg | Placebo | Total |
|---|---|---|---|---|
| Mean | 56.8 (22 to 82) | 54.5 (19 to 90) | 55.1 (20 to 86) | 55.5 (19 to 90) |
| Sex: Female, Male(Participants) | CF101 0.1 mg | CF101 1 mg | Placebo | Total |
|---|---|---|---|---|
| Female | 55 | 62 | 71 | 188 |
| Male | 22 | 16 | 10 | 48 |
| Region of Enrollment(participants) | CF101 0.1 mg | CF101 1 mg | Placebo | Total |
|---|---|---|---|---|
| Israel | 77 | 78 | 81 | 236 |
The record gives a start of Jul 2011, a primary completion of Nov 2013 and a completion of Dec 2013. It does not say whether these dates are actual or estimated.
Results were first posted in Mar 2015, 1 year 4 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: CF101