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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

ConditionsGlaucomaOcular Hypertension
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age22+
SponsorSpyGlass Pharma, Inc.

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • BIM-DRS Low Dose

    Drug

    Bimatoprost-Drug Ring System Low Dose

  • BIM-DRS High Dose

    Drug

    Bimatoprost-Drug Ring System High Dose

  • SpyGlass IOL with silicone pads (no drug)

    Device

    SpyGlass Intraocular Lens with silicone pads (no drug)

Treatment groups

24 Participants
are divided into 4 treatment groups
Group A: Bimatoprost-Drug Ring System Low Dose and Previously Implanted Commercially Available Monofocal IOLExperimental treatment 1 intervention
Group B: Bimatoprost-Drug Ring System High Dose and Previously Implanted Commercially Available Monofocal IOLExperimental treatment 1 intervention
Group C: Bimatoprost-Drug Ring System Low Dose with SpyGlass IOL (IOL with silicone pads (no drug))Experimental treatment 2 interventions
Group D: Bimatoprost-Drug Ring System High Dose with SpyGlass IOL (IOL with silicone pads (no drug))Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Mean IOP change from Baseline (mmHg)

Time frame
Postoperative Week 2, Week 6, and Month 3.

Secondary outcomes

1

Mean IOP (mmHg)

Time frame
Postoperative Week 2, Week 6, and Months 3, 6, 12, 18, 24, 30, and 36
2

Mean IOP change from Baseline (mmHg)

Time frame
Postoperative Months 6, 12, 18, 24, 30, and 36
3

Mean IOP change from Baseline

Time frame
Postoperative Months 6, 12, 18, 24, 30, and 36
4

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

SpyGlass Pharma, Inc.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: