GlaucomaPhase 1NCT07641296
Evaluation of the Safety, Efficacy, Dose Response of the Bimatoprost Drug Ring System (BIM-DRS) in Pseudophakic Patients Diagnosed With Open Angle Glaucoma or Ocular Hypertension
A Phase 1 study testing BIM-DRS Low Dose, BIM-DRS High Dose and SpyGlass IOL with silicone pads (no drug) in people with Glaucoma and Ocular Hypertension, run by SpyGlass Pharma, Inc..
Trial summary
The goal of this clinical trial is to learn if two different doses of the SpyGlass Bimatoprost-Drug Ring System (BIM-DRS) work to treat adult pseudophakic patients with either glaucoma or ocular hypertension. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Glaucoma, Ocular Hypertension
- What is being tested?
- BIM-DRS Low Dose, BIM-DRS High Dose and SpyGlass IOL with silicone pads (no drug)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 31 Jul 2026to 31 Mar 2030
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of mild to moderate open-angle glaucoma or ocular hypertension
- Pseudophakic or 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
Who cannot join
- Uncontrolled systemic disease
- History of incisional/refractive corneal surgery
- Any glaucoma diagnosis other than OHT, open-angle, or pigmentary glaucoma
- History of incisional glaucoma surgery
- Other ocular diseases, pathology, or conditions
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Prospective, Multi-Center, Open-Label, Non-Randomized, Multi-Arm Study to Evaluate the Safety, Efficacy, and Dose Response of the Bimatoprost Drug Ring System (BIM-DRS) in Pseudophakic Patients Implanted With a Posterior Chamber Intraocular Lens (PC-IOL) and Diagnosed With Mild to Moderate Open-Angle Glaucoma (OAG) or Ocular Hypertension (OHT)
The goal of this clinical trial is to learn if two different doses of the SpyGlass Bimatoprost-Drug Ring System (BIM-DRS) work to treat adult pseudophakic patients with either glaucoma or ocular hypertension. The main question it aims to answer is:
Does the BIM-DRS lower the pressure inside the eye to treat glaucoma or ocular hypertension?
Read more
Researchers will compare two different doses of the BIM-DRS implanted either with a pre-existing commercially available monofocal intraocular lens (IOL) or concurrently with the SpyGlass IOL (IOL with silicone pads (no drug)).
Participants will:
- Upon providing informed consent and successfully completing the screening visit, stop taking their IOP lowering medications in the eye to be treated.
- Complete a baseline visit to further evaluate eligibility in the study eye.
- Undergo surgery to implant the BIM-DRS (BIM-DRS and SpyGlass IOL for Cohorts 3 and 4). Only one eye of each participant will be treated.
- Complete post-operative follow-up visits for evaluation at Day 1, Week 2, Week 6, Month 3, Month 6, Month 12, Month 18, Month 24, Month 30, and Month 36 (last study visit).
- Conditions
- Glaucoma, Ocular Hypertension
- Being tested
- BIM-DRS Low Dose, BIM-DRS High Dose, SpyGlass IOL with silicone pads (no drug)
- Medical subject headings
- Glaucoma, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIM-DRS Low DoseDrug
Bimatoprost-Drug Ring System Low Dose
BIM-DRS High DoseDrug
Bimatoprost-Drug Ring System High Dose
SpyGlass IOL with silicone pads (no drug)Device
SpyGlass Intraocular Lens with silicone pads (no drug)
| Study group | Role | What they receive |
|---|---|---|
| Bimatoprost-Drug Ring System Low Dose and Previously Implanted Commercially Available Monofocal IOL | Experimental | Not described Receives: Drug: BIM-DRS Low Dose |
| Bimatoprost-Drug Ring System High Dose and Previously Implanted Commercially Available Monofocal IOL | Experimental | Not described Receives: Drug: BIM-DRS High Dose |
| Bimatoprost-Drug Ring System Low Dose with SpyGlass IOL (IOL with silicone pads (no drug)) | Experimental | Not described Receives: Drug: BIM-DRS Low Dose; Device: SpyGlass IOL with silicone pads (no drug) |
| Bimatoprost-Drug Ring System High Dose with SpyGlass IOL (IOL with silicone pads (no drug)) | Experimental | Not described Receives: Drug: BIM-DRS High Dose; Device: SpyGlass IOL with silicone pads (no drug) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean IOP change from Baseline (mmHg)
Measured: Postoperative Week 2, Week 6, and Month 3.
Secondary outcomes (5)
Mean IOP (mmHg)
Measured: Postoperative Week 2, Week 6, and Months 3, 6, 12, 18, 24, 30, and 36
Mean IOP change from Baseline (mmHg)
Measured: Postoperative Months 6, 12, 18, 24, 30, and 36
Mean IOP change from Baseline
Measured: Postoperative Months 6, 12, 18, 24, 30, and 36
Time to postoperative introduction of additional IOP-lowering medication
Measured: Postoperative Day 1, Week 2, Week 6, Month 3, Month 6, Month 12, Month 18, Month 24, Month 30, and Month 36
Number of additional IOP-lowering medications introduced
Measured: Postoperative Months 3, 6, 12, 18, 24, 30, and 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2026
- Study start31 Jul 2026 (estimated)
- Primary completion28 Feb 2027 (estimated)
- Study completion31 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SpyGlass Pharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07641296
- Sponsor's protocol ID
- SGP-201
- Status last verified
- Jun 2026
- First submitted
- 27 May 2026
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multi-Center, Open-Label, Non-Randomized, Multi-Arm Study to Evaluate the Safety, Efficacy, and Dose Response of the Bimatoprost Drug Ring System (BIM-DRS) in Pseudophakic Patients Implanted With a Posterior Chamber Intraocular Lens (PC-IOL) and Diagnosed With Mild to Moderate Open-Angle Glaucoma (OAG) or Ocular Hypertension (OHT)
- ClinicalTrials.gov ID
- NCT07641296
- Acronym / sponsor ID
- SGP-201
- Conditions
- Glaucoma, Ocular Hypertension
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- SpyGlass Pharma, Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Jul 2026 (estimated)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 31 Mar 2030 (estimated)
- First posted
- 11 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn if two different doses of the SpyGlass Bimatoprost-Drug Ring System (BIM-DRS) work to treat adult pseudophakic patients with either glaucoma or ocular hypertension. The main question it aims to answer is:
Does the BIM-DRS lower the pressure inside the eye to treat glaucoma or ocular hypertension?
Researchers will compare two different doses of the BIM-DRS implanted either with a pre-existing commercially available monofocal intraocular lens (IOL) or concurrently with the SpyGlass IOL (IOL with silicone pads (no drug)).
Participants will:
- Upon providing informed consent and successfully completing the screening visit, stop taking their IOP lowering medications in the eye to be treated.
- Complete a baseline visit to further evaluate eligibility in the study eye.
- Undergo surgery to implant the BIM-DRS (BIM-DRS and SpyGlass IOL for Cohorts 3 and 4). Only one eye of each participant will be treated.
- Complete post-operative follow-up visits for evaluation at Day 1, Week 2, Week 6, Month 3, Month 6, Month 12, Month 18, Month 24, Month 30, and Month 36 (last study visit).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Bimatoprost-Drug Ring System Low Dose and Previously Implanted Commercially Available Monofocal IOL | Experimental | Drug: BIM-DRS Low Dose |
| Bimatoprost-Drug Ring System High Dose and Previously Implanted Commercially Available Monofocal IOL | Experimental | Drug: BIM-DRS High Dose |
| Bimatoprost-Drug Ring System Low Dose with SpyGlass IOL (IOL with silicone pads (no drug)) | Experimental | Drug: BIM-DRS Low Dose, Device: SpyGlass IOL with silicone pads (no drug) |
| Bimatoprost-Drug Ring System High Dose with SpyGlass IOL (IOL with silicone pads (no drug)) | Experimental | Drug: BIM-DRS High Dose, Device: SpyGlass IOL with silicone pads (no drug) |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of mild to moderate open-angle glaucoma or ocular hypertension
- Pseudophakic or 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
Key exclusion criteria (5 listed)
- Uncontrolled systemic disease
- History of incisional/refractive corneal surgery
- Any glaucoma diagnosis other than OHT, open-angle, or pigmentary glaucoma
- History of incisional glaucoma surgery
- Other ocular diseases, pathology, or conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BIM-DRS Low DoseBimatoprost-Drug Ring System Low Dose | Drug | Bimatoprost-Drug Ring System Low Dose and Previously Implanted Commercially Available Monofocal IOL, Bimatoprost-Drug Ring System Low Dose with SpyGlass IOL (IOL with silicone pads (no drug)) |
| BIM-DRS High DoseBimatoprost-Drug Ring System High Dose | Drug | Bimatoprost-Drug Ring System High Dose and Previously Implanted Commercially Available Monofocal IOL, Bimatoprost-Drug Ring System High Dose with SpyGlass IOL (IOL with silicone pads (no drug)) |
| SpyGlass IOL with silicone pads (no drug)SpyGlass Intraocular Lens with silicone pads (no drug) | Device | Bimatoprost-Drug Ring System High Dose with SpyGlass IOL (IOL with silicone pads (no drug)), Bimatoprost-Drug Ring System Low Dose with SpyGlass IOL (IOL with silicone pads (no drug)) |
Primary outcome
Mean IOP change from Baseline (mmHg)
Time frame: Postoperative Week 2, Week 6, and Month 3.
5 secondary outcomes
Mean IOP (mmHg)
Time frame: Postoperative Week 2, Week 6, and Months 3, 6, 12, 18, 24, 30, and 36
Mean IOP change from Baseline (mmHg)
Time frame: Postoperative Months 6, 12, 18, 24, 30, and 36
Mean IOP change from Baseline
Time frame: Postoperative Months 6, 12, 18, 24, 30, and 36
Time to postoperative introduction of additional IOP-lowering medication
Time frame: Postoperative Day 1, Week 2, Week 6, Month 3, Month 6, Month 12, Month 18, Month 24, Month 30, and Month 36
Number of additional IOP-lowering medications introduced
Time frame: Postoperative Months 3, 6, 12, 18, 24, 30, and 36
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- SpyGlass Pharma WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BIM-DRS Low Dose, BIM-DRS High Dose and SpyGlass IOL with silicone pads (no drug) in people with Glaucoma and Ocular Hypertension, run by SpyGlass Pharma, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sr. Vice President, Clinical Development (949-284-6904, clinical@spyglasspharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean IOP change from Baseline (mmHg) (time frame: Postoperative Week 2, Week 6, and Month 3.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.