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CTRI Number  CTRI/2022/12/047937 [Registered on: 07/12/2022] Trial Registered Prospectively
Last Modified On: 18/06/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Phase 2b Study to Assess the Safety, Tolerability and Efficacy of Ocular Drug-Delivering Contact Lens LL-BMT1 in Subjects with POAG or OH. 
Scientific Title of Study   A Dose Escalating, Randomized, Phase 2b Study to Assess the Safety, Tolerability and Efficacy of Ocular Drug-Delivering Contact Lens LL-BMT1 in Subjects with Primary Open-Angle Glaucoma or Ocular Hypertension. 
Trial Acronym  NA 
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
CBCC/2022/015 Version 3.0 dated 09/Oct/2022   Protocol Number 
Version 4.0 dated 03/Mar/2023  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)  
Name  Dr Sandeep Singh 
Designation  Vice President - Clinical Operations 
Affiliation  CBCC Global Research 
Address  TURQUOISE-IV, 6th Floor, Sardar Patel Ring Rd, opp. Apple Woods, Near Shantipura circle

Ahmadabad
GUJARAT
380058
India 
Phone  9637555304  
Fax    
Email  sandeep.singh@cbccusa.com  
 
Details of Contact Person
Scientific Query
Modification(s)  
Name  Dr Sandeep Singh 
Designation  Vice President - Clinical Operations 
Affiliation  CBCC Global Research 
Address  TURQUOISE-IV, 6th Floor, Sardar Patel Ring Rd, opp. Apple Woods, Near Shantipura circle

Ahmadabad
GUJARAT
380058
India 
Phone  9637555304  
Fax    
Email  sandeep.singh@cbccusa.com  
 
Details of Contact Person
Public Query
Modification(s)  
Name  Dr Sandeep Singh 
Designation  Vice President - Clinical Operations 
Affiliation  CBCC Global Research 
Address  TURQUOISE-IV, 6th Floor, Sardar Patel Ring Rd, opp. Apple Woods, Near Shantipura circle

Ahmadabad
GUJARAT
380058
India 
Phone  9637555304  
Fax    
Email  sandeep.singh@cbccusa.com  
 
Source of Monetary or Material Support  
MediPrint Ophthalmics, Inc. 9899 Hibert Street, Suite A San Diego, CA 92131, USA  
 
Primary Sponsor
Modification(s)  
Name  MediPrint Ophthalmics Inc 
Address  5310 Eastgate Mall, San Diego, CA 92121, USA Phone number: 858-335-2873 Email: pdoshi@mediprintlens.com 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NA  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Purvi Raj Bhagat  M and J Western Regional Institute of Ophthalmology   Civil Hospital Campus, Asarwa, Ahmedabad – 380016, Gujarat, India
Ahmadabad
GUJARAT 		 9825985265

dr.purvibhagat@yahoo.com 
Dr Parth Rana  Netralaya Super Speciality Eye Hospital  1st Floor, Kay DEE House, Above Union Bank, Parimal Garden Cross Road, Chimanlal Girdharlal Rd, Ambawadi, Ahmedabad-380006 Gujarat, India
Ahmadabad
GUJARAT 		 7557777755

dr.parth.rana@gmail.com 
Dr Rohan Chauhan  Rising Retina Clinic  312-313, Iskon Centre, Shivranjani Cross Roads, Satellite, Ahmedabad, Gujarat, 380015, India
Ahmadabad
GUJARAT 		 9825203022

rohan_28782@yahoo.co.in 
Dr Deep Joshi  The Eye Center  2nd floor, Platinum plaza, Above platinum Restaurant, Opp Raj Hans theatre, Nr. Sarthak hospital, Nikol-382350, Ahmedabad, Gujarat, India
Ahmadabad
GUJARAT 		 8238004065

drdeepjoshi16@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
Ethics Committee of Care Institute of Medical Sciences  Approved 
Institutional Ethics Committee, B.J. Medical College and Civil Hospital  Approved 
Medilink Ethics Committee  Submittted/Under Review 
Parth Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H401||Open-angle glaucoma,  
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Intervention  LL-BMT1, an investigational device composed of an FDA-approved Group 4 extended-wear contact lens that has bimatoprost coated onto the anterior surface of the lens via an inkjet printer of MediPrint Ophthalmics, Inc.   Dosage: 26 Micro g/lens, 32 Micro g/lens and 40 Micro g/lens, Frequency: Weekly, Route of Administration: Topical, ocular, Duration of Therapy: 21 days.  
Comparator Agent  Timolol 0.5% (b.i.d.) & Bimatoprost ophthalmic solution 0.01% (q.d.) Topical eye drop.   Dosage: 0.5%, Frequency:b.i.d., Route of Administration: Topical eye drop, Duration of Therapy: 21 days. & Dosage: 0.01%, Frequency:q.d., Route of Administration: Topical eye drop, Duration of Therapy: 21 days. 
 
Inclusion Criteria
Modification(s)  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Subjects will be considered eligible for the study based on the following criteria:

1. Male or female subject of at least 18 years of age at the time of screening visit.
2. Diagnosed with POAG or OHT in both eyes.
3. At least one eye (called the study eye) must have an untreated IOP between 22 mmHg and 34 mmHg (both inclusive) as measured at 8 AM (± 1 hour) during the baseline visit. For eyes receiving IOP treatment, untreated IOP will be assessed following a required washout period as outlined below:
4 days washout for parasympathomimetic and topical or systemic carbonic anhydrase inhibitors.
2 weeks washout for sympathomimetics and alpha agonists
4 weeks washout for beta adrenergic blocking agents, combination product, Rho kinase inhibitors, and prostaglandin agonists.
4. If the fellow eye does not meet inclusion criterion #3 above, it must have an untreated IOP (following washout, if applicable) within 5 mmHg of the study eye IOP without exceeding the 34 mmHg maximum (e.g., a study eye IOP of 22 mmHg and a fellow eye IOP of 17 mmHg is allowed).
5. BCVA of Early Treatment Diabetic Retinopathy Study (ETDRS) of 50 letters or better or BCVA of 20/100 or better on Snellen’s chart in each eye.

6. Female of child-bearing potential must not be pregnant or lactating, must have a negative urine pregnancy test at screening and must be practicing an adequate method of birth control, including intrauterine device (IUD); oral, dermal (“patch”), implant or injected contraceptives; tubal ligation; or barrier methods with spermicide.
7. No adverse reactions to nonmedicated contact lenses during the 2-week acclimation screening.
8. Score of 0-11 on CLDEQ-8 (Appendix-I), administered at the end of the 2-week acclimation screening
9. Willing and able to comply with the study procedure and sign a written informed consent
 
 
ExclusionCriteria 
Details  Subjects will be excluded from the study based on the following criteria:

1. Glaucoma or optic neuropathy due to anything other than POAG or OHT
2. Cup-to-disc ratio of >0.8 (horizontal or vertical measurements) in either eye in screening or baseline visit
3. Corneal thickness <480 or >620 Micro m
4. IOP >34 mmHg in either eye at the screening visit or baseline Visit
5. Significant visual field loss, in the opinion of the investigator
6. Any severe and uncontrolled comorbid medical conditions which, in the opinion of the investigator, may either put the subject at risk because of participation in the study or may influence the results of the study, or the subject’s ability to participate in the study.
7. An active ocular infection (i.e., bacterial, viral, parasitic, or fungal) in either eye at the Screening Visit
8. Current contact lens use for vision correction/ cosmetic purposes (unless willing to switch to glasses for the duration of the study)
9. Subject with current or a last 3-month history of severe dry eye in either eye
10. Subjects with meibomian gland dysfunction.
11. History of treated allergic, vernal, or atopic conjunctivitis
12. History of contact lens intolerance, corneal scarring, corneal neovascularization, giant papillary conjunctivitis, or any other corneal pathology that is deemed by the investigator to constitute a contraindication for applying contact lenses
13. Aphakia or presence of anterior chamber intraocular lens in either eye
14. History of clinically significant macular pathology (i.e., progressive age-related macular degeneration, diabetic macular edema, proliferative diabetic retinopathy, etc.) in either eye.
15. History of corneal refractive surgery (i.e., laser-assisted in situ keratomileusis [LASIK], photorefractive keratectomy [PRK], radial keratotomy [RK], small incision lenticule extraction [SMILE], or corneal inlay, etc.) in either eye.
16. History of prior incisional glaucoma surgery (i.e., bleb, shunt, seton, etc.) in either eye.
17. History within past 6 months of any ocular anterior segment laser or other intraocular surgery in either eye
18. Use of laser of any type on retina in either eye within 3 months prior to the screening visit.
19. History of punctal cautery or planned use of punctal plugs during the study in either eye.
20. Cataract surgery in either eye within 3 months, or other intraocular surgery in either eye within 6 months prior to the Screening Visit or planned during the course of the study.
21. Anticipated need for ocular surgery in either eye during the study period.
22. Required chronic use of topical or injectable ocular medications other than IOP-lowering medication, including artificial tears, or currently receiving chronic intravitreal injections.
23. Subjects with bronchial asthma, a history of bronchial asthma, severe chronic obstructive pulmonary disease, sinus bradycardia, second or third degree atrioventricular block, or cardiac failure, overactive thyroid gland, myasthenia gravis.
24. Congestive heart failure (New York Heart Association [NYHA] class III & class IV), angina, myocardial infarction, cerebrovascular accident, coronary/peripheral artery bypass graft surgery, transient ischemic attack, deep vein thrombosis (DVT), heart failure, Pulmonary Thromboembolism (PTE) or pulmonary embolism or any other established major cardiovascular disease prior to screening.
25. Known allergy or hypersensitivity to the IP or its components
26. Treatment with an investigational product or/ participation in a clinical trial within 30 days prior to the screening visit.
27. Employee of the sponsor, investigator, or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees of sponsor or the investigator
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome
Modification(s)  
Outcome  TimePoints 
To evaluate the ocular hypotensive efficacy of up to three doses of LL-BMT1 relative to timolol 0.5% and Bimatoprost ophthalmic solution 0.01% in subjects with POAG or OHT for up to 21 days.  21 Days. 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the ocular safety and tolerability of up to three doses of LL-BMT1 for up to 21 days  21 Days. 
 
Target Sample Size
Modification(s)  		 Total Sample Size="135"
Sample Size from India="135" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   12/12/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="2"
Days="9" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   NONE 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   This is a Dose Escalating, Randomized, Phase 2b Study to Assess the Safety, Tolerability and Efficacy of Ocular Drug-Delivering Contact Lens LL-BMT1 in Subjects with Primary Open-Angle Glaucoma or Ocular Hypertension. 
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