None listed
Conditions
Brief summary
This study is testing whether the eye drop CT2000 is safe and can help reduce eye pain in people with moderate to severe Dry Eye Disease. About 120 adults will take part. The first part will find a safe dose, and the second part will compare CT2000 with a placebo (inactive eye drop) and explore any reduction in eye pain. The main goal is to see if CT2000 is safe to use and if it can reduce eye pain.
Interventions
This is a Phase 1b/2a randomized, double-masked, vehicle as placebo-controlled study evaluating ocular tolerability, safety, and efficacy of CT2000 (10 mg/mL, 12.5 mg/mL and 15 mg/mL) for ocular pain as a function of moderate to severe dry eye disease (DED).
Approximately 120 adults will be enrolled at a single center. The study includes two sequential parts:
Phase 1b: Single Safety Dose and Multiple Ascending Dose (MAD) stages Single Safety Dose stage: Subjects will receive one drop in each ey
This is a Phase 1b/2a randomized, double-masked, vehicle as placebo-controlled study evaluating ocular tolerability, safety, and efficacy of CT2000 (10 mg/mL, 12.5 mg/mL and 15 mg/mL) for ocular pain as a function of moderate to severe dry eye disease (DED). Approximately 120 adults will be enrolled at a single center. The study includes two sequential parts: Phase 1b: Single Safety Dose and Multiple Ascending Dose (MAD) stages Single Safety Dose stage: Subjects will receive one drop in each eye, administered once by site clinical staff in the clinic (3:1 CT2000:vehicle, N= 24). Subjects will remain onsite for observation. Adherence is not applicable as this is a single administration performed by site staff. Multiple Ascending Dose (MAD) stage: Following Safety Review Committee (SRC) review of Safety Dose findings, subjects will instill one drop in each eye four times a day (morning, midday, afternoon, and evening) for 7 days, across three dose levels. Dosing will be self-administered by subjects, except the first daily dose which will be instilled at the clinic. Adherence will be monitored using daily drop diaries and returned empty ampules for drug accountability. MAD begins after completion of the Single Safety Dose visit and review by the SRC. Safety will be reviewed by the SRC before each escalation of dose. The maximum tolerated dose (MTD) will be the highest dose without dose-limiting toxicity. Phase 2a: Four-week, parallel-group comparison of the MTD of CT2000 vs vehicle (1:1 randomization; N = 80). Subjects will instill one drop in each eye four times a day for 28 days, with weekly clinic visits and a Day 35 follow-up call. Dosing is self-administered, and adherence will be monitored through daily drop diaries, returned ampules, and daily telephone check-ins.
Sponsors
Channel Pharmaceutical Corporation Pty, Ltd
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18 to 75 years 2. Subjects must be in good general health, with no significant medical problems that, in the opinion of the Investigator, would preclude participation in the study, at Screening and/or before administration of the dose of IP. 3. Women of childbearing potential (WOCBP) who are sexually active must have a negative urine pregnancy test at Screening. A woman is considered of childbearing potential following menarche and until becoming postmenopausal (no menses for at least 2 years without an alternative cause). 4. Subjects who are sexually active must agree to use highly effective methods of contraception for 14 days prior to Visit 1 through final treatment (Visit 6) or the last administration of the study treatment. 5. WOCBP must be non-pregnant and non-lactating, and must use a medically approved, highly effective contraception method from Screening until study completion, including the follow-up period. 6. Subjects must have the ability and willingness to attend the necessary visits 7. Subjects must be willing and able to provide written informed consent after the nature of the study has been explained and prior to the commencement of any study procedures. 8. Have a diagnosis of moderate to severe dry eye defined by mean corneal fluorescein staining score of NEI grid with a minimum score of 5 out of 15 at Screening 9. Have an OSDI score of 23 or greater 10. Have a mean ocular NRS reading of 5 or greater on an 11 point (0-10) scale at Screening.
Exclusion criteria
1. Current or planned use of any topical or systemic opioid, steroid, non-steroidal anti-inflammatory drugs (NSAID), anticonvulsant, tricyclics and selective serotonin reuptake inhibitors (SSRI)/SSRI +norepinephrine inhibitors, benzodiazepine or other pain-affecting medication. A history of Cyclosporine is allowed with at least 3 months of compliant use and no change in ocular pain in that time. 2. Any of the corneal abnormalities that are clinically significant in the opinion of the Investigator such as, but not limited to: pellucid marginal degeneration (PMD) or general corneal thinning, corneal scar, Fuchs' endothelial dystrophy, guttata, or edema in either eye 3. IOP 23 mmHg in either eye. Any use of eye drops for glaucoma is excluded 4. Laser trabeculectomy and other glaucoma surgeries in either eye 5. Any clinically significant abnormal finding on dilated fundus examination in either eye or known history of retinal detachment, retinal trauma, retinal or vitreal surgery, posterior vitreal detachment, or clinically significant retinal disease in either eye 6. History of optic neuropathy or amblyopia in either eye (anisometropia is allowed). 7. Any acute eye disease within the past 6 months 8. History of ocular trauma in either eye requiring treatment, as deemed by the principal investigator 9. Use of temporary or permanent punctal plugs or history of punctal cautery in one or both eyes if currently in place 10. Use of soft contact lenses in either eye within 30 days of the study or rigid gas permeable contact lenses within 3 months of the study, or planned use during the study 11. Allergy to any of the excipients of the IP 12. Use of protocol-specified disallowed concomitant medications within the past 30 days or anticipated need for their use during the study 13. Serious systemic illness that, in the opinion of the Investigator, would render the subject ineligible 14. Pre-planned hospitalization or ocular or systemic surgery during the study period 15. History of any substance abuse (alcohol and/or illegal drugs) and not willing to abstain from drug(s) and reasonably limit alcohol consumption to approximately 2 alcoholic beverages per day during the study period. A history of medicinal/recreational use of Marijuana is allowed provided the subject abstain for the length of the study 16. Participation in any other study of investigational therapy during the study period or within the last 30 days or 5 half-lives, whichever is longer 17. Unwilling or unable to complete study procedures or to be followed up for the duration of the study
Outcome results
None listed