Dry Eye Clinical Trial
Official title:
Safety, Tolerability, Plug Retention and Preliminary Efficacy of Tacrolimus-loaded Punctal Plug in Patients With Moderate to Severe Dry Eye Disease - Cohort B
Verified date | September 2023 |
Source | Eximore Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Active, not recruiting |
Enrollment | 20 |
Est. completion date | December 30, 2023 |
Est. primary completion date | December 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. Schirmer =1 and =10 mm in both eyes 6. Central corneal thickness of 400-620 microns. 7. 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 |
Country | Name | City | State |
---|---|---|---|
Mexico | Asociación para Evitar la Ceguera en México (APEC) | Mexico City | Coyoacán |
Lead Sponsor | Collaborator |
---|---|
Eximore Ltd. |
Mexico,
Baldo A, Cafiero M, Di Caterino P, Di Costanzo L. Tacrolimus ointment in the management of atopic dermatitis. Clin Cosmet Investig Dermatol. 2009 Jan 27;2:1-7. doi: 10.2147/ccid.s3378. — View Citation
Berdoulay A, English RV, Nadelstein B. Effect of topical 0.02% tacrolimus aqueous suspension on tear production in dogs with keratoconjunctivitis sicca. Vet Ophthalmol. 2005 Jul-Aug;8(4):225-32. doi: 10.1111/j.1463-5224.2005.00390.x. — View Citation
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Hanifin JM, Paller AS, Eichenfield L, Clark RA, Korman N, Weinstein G, Caro I, Jaracz E, Rico MJ; US Tacrolimus Ointment Study Group. Efficacy and safety of tacrolimus ointment treatment for up to 4 years in patients with atopic dermatitis. J Am Acad Derm — View Citation
Kanellopoulos AJ, Asimellis G. In pursuit of objective dry eye screening clinical techniques. Eye Vis (Lond). 2016 Jan 18;3:1. doi: 10.1186/s40662-015-0032-4. eCollection 2016. — View Citation
Moscovici BK, Holzchuh R, Chiacchio BB, Santo RM, Shimazaki J, Hida RY. Clinical treatment of dry eye using 0.03% tacrolimus eye drops. Cornea. 2012 Aug;31(8):945-9. doi: 10.1097/ICO.0b013e31823f8c9b. — View Citation
Reitamo S, Ortonne JP, Sand C, Cambazard F, Bieber T, Folster-Holst R, Vena G, Bos JD, Fabbri P, Groenhoej Larsen C; European Tacrolimus Ointment Study Group. A multicentre, randomized, double-blind, controlled study of long-term treatment with 0.1% tacro — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The primary safety endpoint is adverse events' frequency, severity, and duration. | Main Adverse Event that will be focused on during the study:
Irritation and local discomfort Increased Lacrimation Increased mucus Intraocular inflammation Ocular redness Eyelid Edema Hyperemia conjunctival erythema Keratitis |
Will be evaluated through study completion (6 weeks) | |
Primary | The number of Participants with Treatment-Related Adverse Events | as assessed by CTCAE v4.0 | Will be evaluated through study completion (6 weeks) | |
Secondary | Patient Tolerability | the number of patients discontinuing the study due to plug discomfort. | Will be evaluated through study completion (6 weeks) | |
Secondary | Plug retention rate | Total patients with plugs remained (did not drop out or lost during the study) at study termination / Total patients with successful plug insertions at Baseline *100 | Study termination visit: 6 weeks after plug insertion | |
Secondary | Exploratory Endpoint1 | Change from baseline in the study eye in Dryness VAS. The change of measurements from baseline will also be compared between the study and fellow control eye. | Will be evaluated from baseline to follow up visit 6 (4 weeks from plug insertion) | |
Secondary | Exploratory Endpoint2 | Change from baseline in the study eye in CFS. The change of measurements from baseline will also be compared between the study and fellow control eye. | Will be evaluated from baseline to follow up visit 6 (4 weeks from plug insertion) | |
Secondary | Exploratory Endpoint3 | Change from baseline in the study eye in *Schirmer test. The change of measurements from baseline will also be compared between the study and fellow control eye.
* Change in Schirmer test score would also be compared in visit 3 |
Will be evaluated from baseline to follow up visit 6 (4 weeks from plug insertion) | |
Secondary | Exploratory Endpoint4 | Change from baseline in the study eye in Lissamine green staining. The change of measurements from baseline will also be compared between the study and fellow control eye. | Will be evaluated from baseline to follow up visit 6 (4 weeks from plug insertion) | |
Secondary | Exploratory Endpoint5 | Change from baseline in the study eye in Dryness VAS. The change of measurements from baseline will also be compared between the study and fellow control eye. | Will be evaluated from baseline to termination visit (6 weeks from plug insertion) | |
Secondary | Exploratory Endpoint6 | Change from baseline in the study eye in CFS. The change of measurements from baseline will also be compared between the study and fellow control eye. | Will be evaluated from baseline to termination visit (6 weeks from plug insertion) | |
Secondary | Exploratory Endpoint7 | Change from baseline in the study eye in *Schirmer test score. The change of measurements from baseline will also be compared between the study and fellow control eye.
* Change in Schirmer test score would also be compared in visit 3 |
Will be evaluated from baseline to termination visit (6 weeks from plug insertion) | |
Secondary | Exploratory Endpoint8 | Change from baseline in the study eye in Lissamine green staining. The change of measurements from baseline will also be compared between the study and fellow control eye. | Will be evaluated from baseline to termination visit (6 weeks from plug insertion) |
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