CataractNCT07154797
Evaluation of the Safety and Effectiveness of the Bimatoprost Implant System / IOL Combination in Patients With Ocular Hypertension or Mild to Moderate Open-angle Glaucoma
A study testing Bimatoprost Implant System / IOL Combination in people with Cataract and Ocular Hypertension, run by SpyGlass Pharma, Inc. at 1 site in Honduras.
Trial summary
The goal of this clinical trial is to learn if the SpyGlass Pharma Bimatoprost Implant System / IOL Combination works to treat cataracts and either ocular hypertension or glaucoma. It will also learn about the safety of the Bimatoprost Implant System / IOL Combination. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Cataract, Ocular Hypertension, Glaucoma
- What is being tested?
- Bimatoprost Implant System / IOL Combination
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteHonduras
- Study dates
- 21 Apr 2022to 13 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Diagnosis of mild to moderate open-angle glaucoma or ocular hypertension
Who cannot join
- Pregnant women as confirmed via urine pregnancy test for women of child-bearing age at screening
- History of incisional/refractive corneal surgery
- Pseudoexfoliation, pigmentary glaucoma, traumatic, uveitic, neovascular, or angle-closure glaucoma, or glaucoma associated with vascular disorders
- Other ocular diseases, pathology, or conditions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Trial to Evaluate the Safety and Effectiveness of the Sustained Release Bimatoprost Implant With SpyGlass IOL in Patients With Ocular Hypertension or Mild to Moderate Open-Angle Glaucoma
The goal of this clinical trial is to learn if the SpyGlass Pharma Bimatoprost Implant System / IOL Combination works to treat cataracts and either ocular hypertension or glaucoma. It will also learn about the safety of the Bimatoprost Implant System / IOL Combination. The main questions it aims to answer are:
- Does the Bimatoprost Implant System / IOL Combination lower the pressure inside the eye to treat ocular hypertension or glaucoma?
- Does the Bimatoprost Implant System / IOL Combination correct vision after cataract surgery?
- What medical problems do participants have when treated with the Bimatoprost Implant System / IOL Combination?
Read more
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 standard of care cataract surgery followed by implantation of the Bimatoprost Implant System / IOL Combination. Only one eye of each participant will be treated.
- Complete post-operative follow-up visits for evaluation at Day 1, Week 1, Month 1, Month 3, and Month 6 (last study visit).
Read the detailed description
This is a single center, proof-of-concept, nonrandomized, multi-arm, controlled clinical trial with a 6-month participation period. The study consists of 3 cohorts of up to 10 participants each. Participants are assigned sequentially to cohorts using a nonrandomized intervention model. Participants will receive standard-of-care cataract extraction by phacoemulsification followed by implantation of the SpyGlass Bimatoprost Implant System / IOL Combination (low-dose cohort; medium-dose cohort; and high-dose cohort). The primary endpoint was measured at 6 months. There was no masking in the study design, however, a 2-person reading method was used for all IOP measurements, wherein Observer 1 adjusts the dial and is masked to the reading on the dial and Observer 2 reads and records the value on the source documentation. Participants in this clinical study are seen for the following visits: a Screening visit, an Eligibility visit (Baseline), a Day 0 or Surgery visit, and postoperative visits at Day 1, Week 1, Month 1, Month 3, and Month 6 (Figure 1). Each participant has one eye designated as the study eye.
- Conditions
- Cataract, Ocular Hypertension, Glaucoma
- Being tested
- Bimatoprost Implant System / IOL Combination
- Medical subject headings
- Cataract, Ocular Hypertension, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bimatoprost Implant System / IOL CombinationCombination product
Bimatoprost Implant System used in combination with the SpyGlass intraocular lens
| Study group | Role | What they receive |
|---|---|---|
| Bimatoprost Implant System / IOL Combination Low Dose | Experimental | Bimatoprost Implant System (Low Dose) used in combination with the SpyGlass Intraocular Lens Receives: Combination Product: Bimatoprost Implant System / IOL Combination |
| Bimatoprost Implant System / IOL Combination Medium Dose | Experimental | Bimatoprost Implant System (Medium Dose) used in combination with the SpyGlass Intraocular Lens Receives: Combination Product: Bimatoprost Implant System / IOL Combination |
| Bimatoprost Implant System / IOL Combination High Dose | Experimental | Bimatoprost Implant System (High Dose) used in combination with the SpyGlass Intraocular Lens Receives: Combination Product: Bimatoprost Implant System / IOL Combination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unmedicated eyes with IOP reduction of ≥20% from Baseline to the Month 6
The proportion of unmedicated eyes with IOP reduction of ≥ 20% from Baseline to the Month 6 exam.
Measured: From Baseline until the end of post-operative follow-up at Month 6
Secondary outcomes (2)
Mean change in unmedicated IOP from Baseline to Month 6
Mean change in unmedicated IOP (mmHg) from Baseline to Month 6
Measured: From Baseline until the end of post-operative follow-up at Month 6
Number of topical glaucoma medications
Number of topical glaucoma medications used at Screening compared to Month 6
Measured: From Screening until the end of post-operative follow-up at Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2025
- Study start21 Apr 2022
- Primary completion13 Dec 2022
- Study completion13 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- SpyGlass Pharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sr. Director, Clinical Affairs, Study chair, SpyGlass Pharma, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07154797
- Sponsor's protocol ID
- SGP-SPEC-001
- Status last verified
- Aug 2025
- First submitted
- 22 Aug 2025
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is a proof of concept trial (first in human).
Publications
Tan NE, Katz G, Robles M, Gupta PK, Kahook MY, Sussman G, Yoo P, Radcliffe NM. Prospective Pilot Study of Sustained Release Bimatoprost Implant with SpyGlass Intraocular Lens: 3-Year Results. Ophthalmol Ther. 2026 Feb;15(2):855-874. doi: 10.1007/s40123-026-01313-4. Epub 2026 Feb 1.
PubMed 41621045
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Trial to Evaluate the Safety and Effectiveness of the Sustained Release Bimatoprost Implant With SpyGlass IOL in Patients With Ocular Hypertension or Mild to Moderate Open-Angle Glaucoma
- ClinicalTrials.gov ID
- NCT07154797
- Acronym / sponsor ID
- SGP-SPEC-001
- Conditions
- Cataract, Ocular Hypertension, Glaucoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- SpyGlass Pharma, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Apr 2022 (actual)
- Primary completion
- 13 Dec 2022 (actual)
- Study completion
- 13 Dec 2022 (actual)
- First posted
- 4 Sep 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.
The goal of this clinical trial is to learn if the SpyGlass Pharma Bimatoprost Implant System / IOL Combination works to treat cataracts and either ocular hypertension or glaucoma. It will also learn about the safety of the Bimatoprost Implant System / IOL Combination. The main questions it aims to answer are:
- Does the Bimatoprost Implant System / IOL Combination lower the pressure inside the eye to treat ocular hypertension or glaucoma?
- Does the Bimatoprost Implant System / IOL Combination correct vision after cataract surgery?
- What medical problems do participants have when treated with the Bimatoprost Implant System / IOL Combination?
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 standard of care cataract surgery followed by implantation of the Bimatoprost Implant System / IOL Combination. Only one eye of each participant will be treated.
- Complete post-operative follow-up visits for evaluation at Day 1, Week 1, Month 1, Month 3, and Month 6 (last study visit).
Detailed description
This is a single center, proof-of-concept, nonrandomized, multi-arm, controlled clinical trial with a 6-month participation period. The study consists of 3 cohorts of up to 10 participants each. Participants are assigned sequentially to cohorts using a nonrandomized intervention model. Participants will receive standard-of-care cataract extraction by phacoemulsification followed by implantation of the SpyGlass Bimatoprost Implant System / IOL Combination (low-dose cohort; medium-dose cohort; and high-dose cohort). The primary endpoint was measured at 6 months. There was no masking in the study design, however, a 2-person reading method was used for all IOP measurements, wherein Observer 1 adjusts the dial and is masked to the reading on the dial and Observer 2 reads and records the value on the source documentation. Participants in this clinical study are seen for the following visits: a Screening visit, an Eligibility visit (Baseline), a Day 0 or Surgery visit, and postoperative visits at Day 1, Week 1, Month 1, Month 3, and Month 6 (Figure 1). Each participant has one eye designated as the study eye.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bimatoprost Implant System / IOL Combination Low Dose | Experimental | Combination Product: Bimatoprost Implant System / IOL CombinationBimatoprost Implant System (Low Dose) used in combination with the SpyGlass Intraocular Lens |
| Bimatoprost Implant System / IOL Combination Medium Dose | Experimental | Combination Product: Bimatoprost Implant System / IOL CombinationBimatoprost Implant System (Medium Dose) used in combination with the SpyGlass Intraocular Lens |
| Bimatoprost Implant System / IOL Combination High Dose | Experimental | Combination Product: Bimatoprost Implant System / IOL CombinationBimatoprost Implant System (High Dose) used in combination with the SpyGlass Intraocular Lens |
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
- Diagnosis of mild to moderate open-angle glaucoma or ocular hypertension
Key exclusion criteria (4 listed)
- Pregnant women as confirmed via urine pregnancy test for women of child-bearing age at screening
- History of incisional/refractive corneal surgery
- Pseudoexfoliation, pigmentary glaucoma, traumatic, uveitic, neovascular, or angle-closure glaucoma, or glaucoma associated with vascular disorders
- 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 / IOL CombinationBimatoprost Implant System used in combination with the SpyGlass intraocular lens | Combination product | Bimatoprost Implant System / IOL Combination High Dose, Bimatoprost Implant System / IOL Combination Low Dose, Bimatoprost Implant System / IOL Combination Medium Dose |
Primary outcome
Unmedicated eyes with IOP reduction of ≥20% from Baseline to the Month 6
Time frame: From Baseline until the end of post-operative follow-up at Month 6
The proportion of unmedicated eyes with IOP reduction of ≥ 20% from Baseline to the Month 6 exam.
2 secondary outcomes
Mean change in unmedicated IOP from Baseline to Month 6
Time frame: From Baseline until the end of post-operative follow-up at Month 6
Number of topical glaucoma medications
Time frame: From Screening until the end of post-operative follow-up at Month 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- Derived from this study: PubMed 41621045Tan NE, Katz G, Robles M, Gupta PK, Kahook MY, Sussman G, Yoo P, Radcliffe NM. Prospective Pilot Study of Sustained Release Bimatoprost Implant with SpyGlass Intraocular Lens: 3-Year Results. Ophthalmol Ther. 2026 Feb;15(2):855-874. doi: 10.1007/s40123-026-01313-4. Epub 2026 Feb 1.
- Individual participant dataSharing planned: No. This is a proof of concept trial (first in human).
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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.
Sr. Director, Clinical Affairs 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?
A study testing Bimatoprost Implant System / IOL Combination in people with Cataract and Ocular Hypertension, run by SpyGlass Pharma, Inc. at 1 site in Honduras.
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 4 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: finished, as of the sponsor's last update on 4 Sep 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 Honduras. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Unmedicated eyes with IOP reduction of ≥20% from Baseline to the Month 6 (time frame: From Baseline until the end of post-operative follow-up at Month 6). 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 NCT07154797, which also lists 1 linked publication.
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 4 Sep 2025.