A Phase 1 interventional study of BIM-DRS Low Dose and BIM-DRS High Dose in Glaucoma and Ocular Hypertension, sponsored by SpyGlass Pharma, Inc.. Not yet recruiting. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2026-06-11.
Sponsored by SpyGlass Pharma, Inc. · Phase 1, Interventional, and Treatment
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:
1,419 studies on the registry are indexed under Glaucoma; 221 are open to participants now.
This study's planned enrollment of 24 is below the median of 61 across 964 interventional studies indexed under Glaucoma.
Browse Glaucoma studies →SpyGlass Pharma, Inc. is the lead sponsor of 6 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: BIM-DRS Low Dose
Drug: BIM-DRS High Dose
Drug: BIM-DRS Low Dose · Device: SpyGlass IOL with silicone pads (no drug)
Drug: BIM-DRS High Dose · Device: SpyGlass IOL with silicone pads (no drug)
Bimatoprost-Drug Ring System Low Dose
Bimatoprost-Drug Ring System High Dose
SpyGlass Intraocular Lens with silicone pads (no drug)
Mean IOP change from Baseline (mmHg)
Time frame: Postoperative Week 2, Week 6, and Month 3.
Mean IOP (mmHg)
Time frame: Postoperative Week 2, Week 6, and Months 3, 6, 12, 18, 24, 30, and 36
Mean IOP change from Baseline (mmHg)
Time frame: Postoperative Months 6, 12, 18, 24, 30, and 36
Mean IOP change from Baseline
Time frame: Postoperative Months 6, 12, 18, 24, 30, and 36
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
Number of additional IOP-lowering medications introduced
Time frame: Postoperative Months 3, 6, 12, 18, 24, 30, and 36
No study locations are listed for this record.
Start is estimated for Jul 2026; primary completion for Feb 2027, 6 months later.
Of 18 phase 1 interventional studies under Glaucoma, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 23. This study's planned 6 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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SpyGlass Pharma, Inc.