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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.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cataract Glaucoma Ocular Hypertension Drug: Bimatoprost Implant System (High Dose) Drug: Bimatoprost Implant System (Low Dose) Drug: Timolol Maleate Ophthalmic Solution, 0.5% Device: Commercially Available Aspheric Monofocal Non-Yellow Chromophore IOL Device: SpyGlass IOL Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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%
Actual Study Start Date : October 13, 2023
Estimated Primary Completion Date : August 2024
Estimated Study Completion Date : June 2027

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Bimatoprost Implant System (High Dose) / IOL Combination Drug: Bimatoprost Implant System (High Dose)
Bimatoprost Implant System (High Dose) used in combination with the SpyGlass IOL

Device: SpyGlass IOL
SpyGlass Intraocular Lens
Experimental: Bimatoprost Implant System (Low Dose) / IOL Combination Drug: Bimatoprost Implant System (Low Dose)
Bimatoprost Implant System (Low Dose) used in combination with the SpyGlass IOL

Device: SpyGlass IOL
SpyGlass Intraocular Lens
Active Comparator: Timolol Maleate Ophthalmic Solution 0.5% 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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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)

  4. 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

  5. Proportion of eyes achieving BCDVA 20/40 or better [ Time Frame: Months 3, 6, and 12 ]
    Snellen Equivalent

  6. Manifest refraction spherical equivalent [ Time Frame: Month 3 ]
    Manifest refraction spherical equivalent (MRSE)


Other Outcome Measures:
  1. Number and Rates of Adverse Events [ Time Frame: Total Study Period of 36 Months ]

Eligibility Criteria
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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06120842


Contacts
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Contact: Chris Hafner 18184421564 chris@spyglasspharma.com

Locations
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United States, Arizona
Arizona Advanced Eye Research Institute Recruiting
Glendale, Arizona, United States, 85306
Contact: Pat Dawson         
Sponsors and Collaborators
SpyGlass Pharma, Inc.
Investigators
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Study Chair: Chris Hafner SpyGlass Pharma, Inc.
More Information
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Additional Information:

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Responsible Party: SpyGlass Pharma, Inc.
ClinicalTrials.gov Identifier: NCT06120842    
Other Study ID Numbers: SGP-003
First Posted: November 7, 2023    Key Record Dates
Last Update Posted: November 13, 2023
Last Verified: November 2023

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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
Additional relevant MeSH terms:
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Cataract
Ocular Hypertension
Eye Diseases
Lens Diseases
Timolol
Bimatoprost
Ophthalmic Solutions
Pharmaceutical Solutions
 Molecular Mechanisms of Pharmacological Action
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents