TERMINATED

The Study Assessing the Safety and Efficacy of OK-101 Treatment in Subjects With Neuropathic Corneal Pain

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The primary objective of this study, in subjects with Neuropathic Corneal Pain, is to evaluate the efficacy and safety of OK-101 0.05% and 0.1% as compared to placebo instilled 4 times/day in subjects with neuropathic corneal pain, as assessed by visual analogue scale (VAS).

Official Title

A Phase 2a, Randomized, Double-Masked, Placebo-Controlled Study Assessing the Safety and Efficacy of OK-101 Treatment in Subjects With Neuropathic Corneal Pain

Quick Facts

Study Start:2024-10-15

Study Completion:2025-07-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:TERMINATED

Study ID

NCT06637527

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Male or female aged ≥ 18 years. 2. Symptoms of neuropathic corneal pain for at least 3 months, such as burning, stinging, light sensitivity, discomfort, or pain. 3. Positive IVCM findings evaluated by an experienced ophthalmologist (Pedram Hamrah, M.D.): decreased nerve density AND evidence of microneuromas. 4. Females of childbearing potential must have a negative pregnancy test. 5. Best corrected distance visual acuity (BCDVA), using corrective lenses, if necessary, in the study eye of at least +1.0 Log MAR (Snellen \<20/200). 6. Satisfying all Informed Consent requirements. 7. Ability and willingness to comply with study procedures.	1. Evidence of any active ocular infection. 2. Evidence of any intraocular inflammation. 3. Evidence of any persistent epithelial defect/ulcer. 4. Evidence of any corneal scar/corneal edema. 5. Presence of any other ocular conditions that require topical medications during the treatment phase. 6. History of severe systemic allergy or severe ocular allergy. 7. Inability to suspend topical medications 8 days prior to the starting date. 8. Inability to continue oral medications for NCP without changes during the study duration. 9. No changes or less than 50% improvement in VAS score after topical 0.5% proparacaine hydrochloride (Alcaine, Alcon, Fort Worth, TX). 10. History of any ocular surgery within three months before study Visit 1(day 0). 11. Ocular surgery expected during the 16 weeks of the trial. 12. Use of refractive/therapeutic contact lenses during the study period. 13. Female subjects who are pregnant/have a positive pregnancy test result or are breastfeeding or intend to become pregnant during the study treatment period. 14. Drug addiction/alcohol abuse within the last year. 15. Participation in another clinical trial concurrently.

Inclusion Criteria

Exclusion Criteria

1. Male or female aged ≥ 18 years.
2. Symptoms of neuropathic corneal pain for at least 3 months, such as burning, stinging, light sensitivity, discomfort, or pain.
3. Positive IVCM findings evaluated by an experienced ophthalmologist (Pedram Hamrah, M.D.): decreased nerve density AND evidence of microneuromas.
4. Females of childbearing potential must have a negative pregnancy test.
5. Best corrected distance visual acuity (BCDVA), using corrective lenses, if necessary, in the study eye of at least +1.0 Log MAR (Snellen \<20/200).
6. Satisfying all Informed Consent requirements.
7. Ability and willingness to comply with study procedures.

1. Evidence of any active ocular infection.
2. Evidence of any intraocular inflammation.
3. Evidence of any persistent epithelial defect/ulcer.
4. Evidence of any corneal scar/corneal edema.
5. Presence of any other ocular conditions that require topical medications during the treatment phase.
6. History of severe systemic allergy or severe ocular allergy.
7. Inability to suspend topical medications 8 days prior to the starting date.
8. Inability to continue oral medications for NCP without changes during the study duration.
9. No changes or less than 50% improvement in VAS score after topical 0.5% proparacaine hydrochloride (Alcaine, Alcon, Fort Worth, TX).
10. History of any ocular surgery within three months before study Visit 1(day 0).
11. Ocular surgery expected during the 16 weeks of the trial.
12. Use of refractive/therapeutic contact lenses during the study period.
13. Female subjects who are pregnant/have a positive pregnancy test result or are breastfeeding or intend to become pregnant during the study treatment period.
14. Drug addiction/alcohol abuse within the last year.
15. Participation in another clinical trial concurrently.

Contacts and Locations

Principal Investigator

Pedram Hamrah, MD

PRINCIPAL_INVESTIGATOR

Tufts Medical Center

Study Locations (Sites)

Tufts Medical Center

Boston, Massachusetts, 02111

United States

Collaborators and Investigators

Sponsor: Okyo Pharma Ltd

Pedram Hamrah, MD, PRINCIPAL_INVESTIGATOR, Tufts Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-15

Study Completion Date2025-07-01

Study Record Updates

Study Start Date2024-10-15

Study Completion Date2025-07-01

Terms related to this study

Additional Relevant MeSH Terms

Neuropathic Pain