Health TrialsbyHealthPanel

Evaluation of the Safety and Efficacy of the Bimatoprost Implant System Used in Combination With the SpyGlass IOL Compared to Timolol Ophthalmic Solution (Rhine)

ConditionsCataractGlaucomaOcular Hypertension
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age22+
SponsorSpyGlass Pharma, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Bimatoprost Implant System

    Drug

    Bimatoprost Implant System used in combination with the SpyGlass IOL

  • SpyGlass IOL

    Device

    SpyGlass Intraocular Lens

  • Timolol Maleate Ophthalmic Solution, 0.5%

    Drug

    Timolol Maleate Ophthalmic Solution, 0.5% BID

  • Commercial IOL

    Device

    Commercially Available Aspheric Monofocal Non-Yellow Chromophore Intraocular Lens

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: Bimatoprost Implant System / IOL CombinationExperimental treatment 2 interventions
Group B: Timolol Maleate Ophthalmic Solution 0.5%Active comparator 2 interventions

Trial outcomes

Primary outcomes

1

Mean IOP Reduction from Baseline (mmHg)

Time-matched mean IOP change from Baseline in the study eyes at all the individual IOP timepoints

Time frame
Weeks 2 and 6, and Month 3
2

BCDVA 20/40 or better

Study eyes achieving best corrected distance visual acuity (BCDVA) of 20/40 or better

Time frame
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

Time frame
Month 6, 9 and 12

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

SpyGlass Pharma, Inc.

Lead sponsor

Source ClinicalTrials.gov
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