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Trial record 1 of 1 for:    Spyglass pharma
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Evaluation of the Bimatoprost Implant System Used in Combination With the SpyGlass Intraocular Lens Compared to Timolol Ophthalmic Solution (Tigris)

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ClinicalTrials.gov Identifier: NCT06120842
Recruitment Status : Recruiting
First Posted : November 7, 2023
Last Update Posted : November 13, 2023
Sponsor:
Information provided by (Responsible Party):
SpyGlass Pharma, Inc.

Tracking Information
First Submitted Date  ICMJE November 1, 2023
First Posted Date  ICMJE November 7, 2023
Last Update Posted Date November 13, 2023
Actual Study Start Date  ICMJE October 13, 2023
Estimated Primary Completion Date August 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 1, 2023)		 Mean IOP Reduction from Baseline (mmHg) [ Time Frame: Weeks 2 and 6, and Month 3 ]
Time matched mean IOP reduction from Baseline (mmHg) in the study eyes at all the individual IOP timepoints
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 1, 2023)
  • Mean IOP [ Time Frame: Weeks 2 and 6 and Months 3, 6, 12, 18, 24, 27, 30, 33, and 36 ]
    Time matched mean IOP (mmHg) at Weeks 2 and 6 and Months 3, 6, 12, 18, 24, 27, 30, 33, and 36
  • Mean IOP Change from Baseline [ Time Frame: Months 6, 12, 18, 24, 27, 30, 33, and 36 ]
    Time matched mean IOP change from Baseline (mmHg) at Months 6, 12, 18, 24, 27, 30, 33, and 36
  • Time to postoperative introduction of IOP-lowering medications [ Time Frame: Total Study Period of 36 Months ]
    Time (Days) to postoperative introduction of IOP-lowering medications (IOP-lowering medications other than the study treatments)
  • Number of IOP-lowering medications introduced postoperatively [ Time Frame: Total Study Period of 36 Months ]
    Number of IOP-lowering medications introduced postoperatively (N) at Weeks 2 and 6, and Months 3, 6, 12, 18, 24, 27, 30, 33, and 36
  • Proportion of eyes achieving BCDVA 20/40 or better [ Time Frame: Months 3, 6, and 12 ]
    Snellen Equivalent
  • Manifest refraction spherical equivalent [ Time Frame: Month 3 ]
    Manifest refraction spherical equivalent (MRSE)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: November 8, 2023)		 Number and Rates of Adverse Events [ Time Frame: Total Study Period of 36 Months ]
Original Other Pre-specified Outcome Measures
 (submitted: November 1, 2023)		 Adverse Events [ Time Frame: Total Study Period of 36 Months ]
 
Descriptive Information
Brief Title  ICMJE Evaluation of the Bimatoprost Implant System Used in Combination With the SpyGlass Intraocular Lens Compared to Timolol Ophthalmic Solution
Official Title  ICMJE A Prospective, Multicenter, Randomized, Masked, Controlled Study to Evaluate the Safety, Efficacy, and Dose-response of the Bimatoprost Implant System Used in Combination With the SpyGlass IOL Compared to Timolol Maleate Ophthalmic Solution, USP, 0.5%
Brief Summary This trial is a randomized study to evaluate and compare two doses of the Bimatoprost Implant System used in combination with the SpyGlass IOL to Timolol Ophthalmic Solution in participants with mild to moderate open-angle glaucoma or ocular hypertension undergoing cataract surgery.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Cataract
  • Glaucoma
  • Ocular Hypertension
Intervention  ICMJE
  • Drug: Bimatoprost Implant System (High Dose)
    Bimatoprost Implant System (High Dose) used in combination with the SpyGlass IOL
  • Drug: Bimatoprost Implant System (Low Dose)
    Bimatoprost Implant System (Low Dose) used in combination with the SpyGlass IOL
  • Drug: Timolol Maleate Ophthalmic Solution, 0.5%
    Timolol Maleate Ophthalmic Solution 0.5% BID
  • Device: Commercially Available Aspheric Monofocal Non-Yellow Chromophore IOL
    Commercially Available Aspheric Monofocal Non-Yellow Chromophore Intraocular Lens
  • Device: SpyGlass IOL
    SpyGlass Intraocular Lens
Study Arms  ICMJE
  • Experimental: Bimatoprost Implant System (High Dose) / IOL Combination
    Interventions:
    • Drug: Bimatoprost Implant System (High Dose)
    • Device: SpyGlass IOL
  • Experimental: Bimatoprost Implant System (Low Dose) / IOL Combination
    Interventions:
    • Drug: Bimatoprost Implant System (Low Dose)
    • Device: SpyGlass IOL
  • Active Comparator: Timolol Maleate Ophthalmic Solution 0.5%
    Interventions:
    • Drug: Timolol Maleate Ophthalmic Solution, 0.5%
    • Device: Commercially Available Aspheric Monofocal Non-Yellow Chromophore IOL
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 1, 2023)		 140
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2027
Estimated Primary Completion Date August 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of mild to moderate open-angle glaucoma or ocular hypertension
  • Planned removal of cataract
  • Female participants of childbearing potential must have a negative urine pregnancy test at the baseline visit and agree to the use of contraception

Exclusion Criteria:

  • Uncontrolled systemic disease
  • History of incisional/refractive corneal surgery
  • Any glaucoma diagnosis other than OHT, open-angle, pseudoexfoliation, or pigmentary glaucoma
  • History of incisional glaucoma surgery or intraocular injections
  • Other ocular diseases, pathology, or conditions
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 22 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Chris Hafner 18184421564 chris@spyglasspharma.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT06120842
Other Study ID Numbers  ICMJE SGP-003
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party SpyGlass Pharma, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE SpyGlass Pharma, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Chris Hafner SpyGlass Pharma, Inc.
PRS Account SpyGlass Pharma, Inc.
Verification Date November 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP