CataractPhase 1/2TigrisNCT06120842

Evaluation of the Bimatoprost Implant System Used in Combination With the SpyGlass Intraocular Lens Compared to Timolol Ophthalmic Solution

A Phase 1/2 study testing Bimatoprost Implant System (High Dose), Bimatoprost Implant System (Low Dose) and Timolol Maleate Ophthalmic Solution, 0.5% in people with Cataract and Glaucoma, run by SpyGlass Pharma, Inc. at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial 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. 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 (High Dose), Bimatoprost Implant System (Low Dose) 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: 201 participants
Where: 1 siteUnited States
Study dates: 13 Oct 2023to Nov 2027
Phase: Phase 1/2
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, pseudoexfoliation, 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.

United States1 site

Arizona Advanced Eye Research Institute
Glendale, Arizona, 85306

Other trials in United States

About this study

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%

Conditions: Cataract, Glaucoma, Ocular Hypertension
Being tested: Bimatoprost Implant System (High Dose), Bimatoprost Implant System (Low Dose), Timolol Maleate Ophthalmic Solution, 0.5%, Commercially Available Aspheric Monofocal Non-Yellow Chromophore IOL, SpyGlass 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 System (High Dose)Drug
Bimatoprost Implant System (High Dose) used in combination with the SpyGlass IOL
Bimatoprost Implant System (Low Dose)Drug
Bimatoprost Implant System (Low Dose) used in combination with the SpyGlass IOL
Timolol Maleate Ophthalmic Solution, 0.5%Drug
Timolol Maleate Ophthalmic Solution 0.5% BID
Commercially Available Aspheric Monofocal Non-Yellow Chromophore IOLDevice
Commercially Available Aspheric Monofocal Non-Yellow Chromophore Intraocular Lens
SpyGlass IOLDevice
SpyGlass Intraocular Lens

Study groups in NCT06120842
Study group	Role	What they receive
Bimatoprost Implant System (High Dose) / IOL Combination	Experimental	Not described Receives: Drug: Bimatoprost Implant System (High Dose); Device: SpyGlass IOL
Bimatoprost Implant System (Low Dose) / IOL Combination	Experimental	Not described Receives: Drug: Bimatoprost Implant System (Low Dose); Device: SpyGlass IOL
Timolol Maleate Ophthalmic Solution 0.5%	Active comparator	Not described Receives: Drug: Timolol Maleate Ophthalmic Solution, 0.5%; Device: Commercially Available Aspheric Monofocal Non-Yellow Chromophore 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 reduction from Baseline (mmHg) in the study eyes at all the individual IOP timepoints
Measured: Weeks 2 and 6, and Month 3

Secondary outcomes (6)

Mean IOP
Time matched mean IOP (mmHg) at Weeks 2 and 6 and Months 3, 6, 12, 18, 24, 27, 30, 33, and 36
Measured: Weeks 2 and 6 and Months 3, 6, 12, 18, 24, 27, 30, 33, and 36
Mean IOP Change from Baseline
Time matched mean IOP change from Baseline (mmHg) at Months 6, 12, 18, 24, 27, 30, 33, and 36
Measured: Months 6, 12, 18, 24, 27, 30, 33, and 36
Time to postoperative introduction of IOP-lowering medications
Time (Days) to postoperative introduction of IOP-lowering medications (IOP-lowering medications other than the study treatments)
Measured: Total Study Period of 36 Months
Number of IOP-lowering medications introduced postoperatively
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
Measured: Total Study Period of 36 Months
Proportion of eyes achieving BCDVA 20/40 or better
Snellen Equivalent
Measured: Months 3, 6, and 12
Manifest refraction spherical equivalent
Manifest refraction spherical equivalent (MRSE)
Measured: Month 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Oct 2023Nov 2027

First posted7 Nov 2023
Study start13 Oct 2023
Primary completion31 Jan 2025
Study completionNov 2027 (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 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 201 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06120842
Sponsor's protocol ID: SGP-003
Acronym: Tigris
Status last verified: Aug 2025
First submitted: 1 Nov 2023
Last updated: 22 Aug 2025
Results posted: No
FDA-regulated drug: Yes
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Cataract trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Aug 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, 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%
ClinicalTrials.gov ID: NCT06120842
Acronym / sponsor ID: Tigris / SGP-003
Conditions: Cataract, Glaucoma, Ocular Hypertension
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 201 participants (actual)
Lead sponsor: SpyGlass Pharma, Inc.Industry (pharma, biotech, devices)
Study start: 13 Oct 2023 (actual)
Primary completion: 31 Jan 2025 (actual)
Study completion: Nov 2027 (estimated)
First posted: 7 Nov 2023 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Bimatoprost Implant System (High Dose) / IOL Combination	Experimental	Drug: Bimatoprost Implant System (High Dose), Device: SpyGlass IOL
Bimatoprost Implant System (Low Dose) / IOL Combination	Experimental	Drug: Bimatoprost Implant System (Low Dose), Device: SpyGlass IOL
Timolol Maleate Ophthalmic Solution 0.5%	Active comparator	Drug: Timolol Maleate Ophthalmic Solution, 0.5%, Device: Commercially Available Aspheric Monofocal Non-Yellow Chromophore 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, pseudoexfoliation, 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 System (High Dose)Bimatoprost Implant System (High Dose) used in combination with the SpyGlass IOL	Drug	Bimatoprost Implant System (High Dose) / IOL Combination
Bimatoprost Implant System (Low Dose)Bimatoprost Implant System (Low Dose) used in combination with the SpyGlass IOL	Drug	Bimatoprost Implant System (Low Dose) / IOL Combination
Timolol Maleate Ophthalmic Solution, 0.5%Timolol Maleate Ophthalmic Solution 0.5% BID	Drug	Timolol Maleate Ophthalmic Solution 0.5%
Commercially Available Aspheric Monofocal Non-Yellow Chromophore IOLCommercially Available Aspheric Monofocal Non-Yellow Chromophore Intraocular Lens	Device	Timolol Maleate Ophthalmic Solution 0.5%
SpyGlass IOLSpyGlass Intraocular Lens	Device	Bimatoprost Implant System (High Dose) / IOL Combination, Bimatoprost Implant System (Low Dose) / IOL Combination

Primary outcome

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

6 secondary outcomes

Mean IOP
Time frame: 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 to postoperative introduction of IOP-lowering medications
Time frame: Total Study Period of 36 Months
Number of IOP-lowering medications introduced postoperatively
Time frame: Total Study Period of 36 Months
Proportion of eyes achieving BCDVA 20/40 or better
Time frame: Months 3, 6, and 12
Manifest refraction spherical equivalent
Time frame: Month 3

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 22 Aug 2025.
SpyGlass Pharma WebsiteLink provided by the sponsor.

Related trials for Cataract

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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. This study is not recruiting at the moment.

Chris Hafner study chair

SpyGlass Pharma, Inc.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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: under way, not looking for participants, as of the sponsor's last update on 22 Aug 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06120842.

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 22 Aug 2025.