Safety, Tolerability and Preliminary Efficacy of Tacrolimus-loaded Punctal Plug in Patients With Moderate to Severe Dry Eye Disease - Cohort B

• Status: Recruiting
• Trial end date: 2023-05-30
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this interventional study is to assess safety, patient tolerability, plug retention rate, and preliminary efficacy in improving the symptoms of Dry Eye Disease (DED) of EXP-TC tacrolimus releasing punctal plug. The main questions it aims to answer are:

1. The safety of using EXP-TC plug following all study adverse events

2. The number of patients with Adverse Events related to the us of EXP-LP plug

3. The number of patients discontinuing the study due to plug discomfort

4. The total patients with plugs remained during the 3-months study duration from plug insertion

5. Exploratory: change from baseline in the study eye to follow-up visits in various Dryness clinical measurements. The change of measurements from baseline will also be compared between the study and fellow control eye (receiving artificial tears only, 0.15% sodium hyaluronate).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eximore Ltd.
• Treatments: Lubricant Eye Drops; Ophthalmic Solutions

Criteria

Inclusion Criteria:

1. Male or female, 18 years of age and over;

2. Patient-reported history of DED in both eyes

3. Use of artificial tears within 3 months before the Screening Visit

4. Corneal fluorescein staining score ≥2 (0- to 4-point scale) in ≥1 region (superior, inferior, or central) in at least one eye

5. Eye Dryness Score - VAS ≥40 (100-point scale; 0 = no discomfort, 100 = maximal discomfort) in at-least one eye

6. Schirmer ≥1 and ≤10 mm in both eyes

7. Central corneal thickness of 400-620 microns.

8. IOP ≤ 24 mmHg in each eye

Exclusion Criteria:

1. Intolerance or contraindication to Tacrolimus

2. Stevens-Johnson Syndrome;

3. Use of methotrexate or systemic cyclosporine within the 3 months before the Screening Visit;

4. Using systemic anti-rheumatic therapy, if started within 6 months before recruitment OR that the systemic disease is considered unstable OR that the patient is unsure of continuing using the treatment throughout the current study;

5. Use of any anti-rheumatic biological agent within 2 months, or 5 half-lives, whichever is longer, before the Screening Visit;

6. Use of oral corticosteroids >10 mg prednisone, or equivalent, per day, if started within 2 months before screening;

7. Use of topical steroids within 4 weeks before the Screening Visit and for the duration of the study

8. Use of oral statin or preparation containing omega-3 fatty acid unless dose has been stable for at least 3 months and will remain so during the trial;

9. Presence of chronic ocular disease other than Aqueous-Deficient Dry Eye requiring topical treatment.

10. Presence of post-burn ocular injury;

11. Active ocular herpes simplex virus infection;

12. Concomitant use of contact lenses or use within 3 months before the Screening Visit or inability to abstain from contact lens use throughout the study.

13. Persistent intraocular inflammation or infection;

14. Have anterior blepharitis, which is deemed clinically significant and likely to interfere with study parameters in the opinion of the investigator;

15. Meibomian gland dysfunction (MGD) necessitating treatment in the 4 weeks before or planned during the study period.

16. Surgical occlusion of the lacrimal puncta, including the insertion of punctual plugs, within 3 months of the Screening

17. Continuous cough OR fever/high temperature (38.0oC or greater) OR loss of/change in the sense of smell or taste (anosmia).

18. Recent ocular or eyelid surgery

19. Pregnant women or women suspected of being pregnant, nursing mothers

20. Inability to abstain from any topical ocular treatments other than unpreserved artificial tears for the duration of the trial

21. Use of autologous serum eye drops (ASED) if started within 2 weeks before the Screening Visit