CataractPhase 3NCT07218796
Evaluation of the Safety and Efficacy of the Bimatoprost Implant System Used in Combination With the SpyGlass IOL Compared to Timolol Ophthalmic Solution (Rhone)
A Phase 3 study testing Bimatoprost Implant System, SpyGlass IOL and Timolol Maleate Ophthalmic Solution, 0.5% in people with Cataract and Glaucoma, run by SpyGlass Pharma, Inc. at 1 site in United States.
Trial summary
This trial is a randomized study to evaluate 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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Cataract, Glaucoma, Ocular Hypertension
- What is being tested?
- Bimatoprost Implant System, SpyGlass IOL and Timolol Maleate Ophthalmic Solution, 0.5%
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Oct 2025to 31 May 2031
- Phase
- Phase 3
- 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
- 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, pseudoexfoliative, or pigmentary glaucoma
- History of incisional glaucoma surgery or intraocular injections
- Other ocular diseases, pathology, or conditions
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
R and R Eye Research, LLC
San Antonio, Texas, 78229
Clinical Research Coordinator, 2104242584, maggie@eye-assoc.com
About this study
Official title: A Prospective, Multicenter, Randomized, Masked, Controlled Study to Evaluate the Safety and Efficacy of the Bimatoprost Implant System (78 mcg) Used in Combination With the SpyGlass IOL Compared to Timolol Maleate Ophthalmic Solution, USP, 0.5%,
This trial is a randomized study to evaluate 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.
- Conditions
- Cataract, Glaucoma, Ocular Hypertension
- Being tested
- Bimatoprost Implant System, SpyGlass IOL, Timolol Maleate Ophthalmic Solution, 0.5%, Commercial IOL
- Medical subject headings
- Cataract, Glaucoma, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bimatoprost Implant SystemDrug
Bimatoprost Implant System used in combination with the SpyGlass IOL
SpyGlass IOLDevice
SpyGlass Intraocular Lens
Timolol Maleate Ophthalmic Solution, 0.5%Drug
Timolol Maleate Ophthalmic Solution, 0.5% BID
Commercial IOLDevice
Commercially Available Aspheric Monofocal Non-Yellow Chromophore Intraocular Lens
| Study group | Role | What they receive |
|---|---|---|
| Bimatoprost Implant System / IOL Combination | Experimental | Not described Receives: Drug: Bimatoprost Implant System; Device: SpyGlass IOL |
| Timolol Maleate Ophthalmic Solution 0.5% | Active comparator | Not described Receives: Drug: Timolol Maleate Ophthalmic Solution, 0.5%; Device: Commercial IOL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean IOP Reduction from Baseline (mmHg)
Time-matched mean IOP change from Baseline in the study eyes at all the individual IOP timepoints
Measured: Weeks 2 and 6, and Month 3
BCDVA 20/40 or better
Study eyes achieving best corrected distance visual acuity (BCDVA) of 20/40 or better
Measured: Month 6
Secondary outcomes (1)
Mean IOP Reduction from Baseline (mmHg)
Time matched mean IOP reduction from Baseline (mmHg) in the study eyes at all the individual IOP timepoints
Measured: Month 6, 9 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2025
- Study start28 Oct 2025 (estimated)
- Primary completion31 May 2029 (estimated)
- Study completion31 May 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SpyGlass Pharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paul Yoo, OD, Study chair, SpyGlass Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07218796
- Sponsor's protocol ID
- SGP-006
- Status last verified
- Oct 2025
- First submitted
- 16 Oct 2025
- Last updated
- 20 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized, Masked, Controlled Study to Evaluate the Safety and Efficacy of the Bimatoprost Implant System (78 mcg) Used in Combination With the SpyGlass IOL Compared to Timolol Maleate Ophthalmic Solution, USP, 0.5%,
- ClinicalTrials.gov ID
- NCT07218796
- Acronym / sponsor ID
- SGP-006
- Conditions
- Cataract, Glaucoma, Ocular Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- SpyGlass Pharma, Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Oct 2025 (estimated)
- Primary completion
- 31 May 2029 (estimated)
- Study completion
- 31 May 2031 (estimated)
- First posted
- 20 Oct 2025 (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.
This trial is a randomized study to evaluate 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bimatoprost Implant System / IOL Combination | Experimental | Drug: Bimatoprost Implant System, Device: SpyGlass IOL |
| Timolol Maleate Ophthalmic Solution 0.5% | Active comparator | Drug: Timolol Maleate Ophthalmic Solution, 0.5%, Device: Commercial IOL |
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
- 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, pseudoexfoliative, or pigmentary glaucoma
- History of incisional glaucoma surgery or intraocular injections
- 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 |
|---|---|---|
| Bimatoprost Implant SystemBimatoprost Implant System used in combination with the SpyGlass IOL | Drug | Bimatoprost Implant System / IOL Combination |
| SpyGlass IOLSpyGlass Intraocular Lens | Device | Bimatoprost Implant System / IOL Combination |
| Timolol Maleate Ophthalmic Solution, 0.5%Timolol Maleate Ophthalmic Solution, 0.5% BID | Drug | Timolol Maleate Ophthalmic Solution 0.5% |
| Commercial IOLCommercially Available Aspheric Monofocal Non-Yellow Chromophore Intraocular Lens | Device | Timolol Maleate Ophthalmic Solution 0.5% |
Primary outcome
Mean IOP Reduction from Baseline (mmHg)
Time frame: Weeks 2 and 6, and Month 3
Time-matched mean IOP change from Baseline in the study eyes at all the individual IOP timepoints
BCDVA 20/40 or better
Time frame: Month 6
Study eyes achieving best corrected distance visual acuity (BCDVA) of 20/40 or better
1 secondary outcome
Mean IOP Reduction from Baseline (mmHg)
Time frame: Month 6, 9 and 12
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 20 Oct 2025.
- 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.
Paul Yoo, OD study chair
SpyGlass Pharma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bimatoprost Implant System, SpyGlass IOL and Timolol Maleate Ophthalmic Solution, 0.5% in people with Cataract and Glaucoma, run by SpyGlass Pharma, Inc. at 1 site in United States.
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: looking for participants now, as of the sponsor's last update on 20 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Director, Clinical Affairs (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 Reduction from Baseline (mmHg) (time frame: Weeks 2 and 6, and Month 3). The study lists 2 primary outcomes in all. 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 20 Oct 2025.