A Phase 2 interventional study of High Dose Device and Low Dose Device in Glaucoma, Open-Angle and Ocular Hypertension, sponsored by Vistakon Pharmaceuticals. Completed at 4 sites in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2015-03-06.
Sponsored by Vistakon Pharmaceuticals · Phase 2, Interventional, and Treatment
The purpose of this study is to evaluate the ocular safety and efficacy of a glaucoma drug delivery system in open-angle glaucoma or ocular hypertension.
1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.
This study's enrollment of 55 is below the median of 65 across 1,272 interventional studies indexed under Glaucoma.
Browse Glaucoma studies →Vistakon Pharmaceuticals is the lead sponsor of 12 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
device worn continuously for 14 days
Drug: High Dose Device
device worn continuously for 14 days
Drug: Low Dose Device
device worn continuously for 14 days
Device: Placebo Device
inserted for 14 days
inserted for 14 days
inserted for 14 days
Visual Acuity - Right Eye
This outcome measures visual acuity in logMARs. logMAR is the logarithm of the minimum angle of resolution (logMAR). The ideal is 0.0 and represents 20/20 Snellen acuity. logMar values \> 0.00 indicate vision poorer than the ideal and values \<0.00 indicate vision greater than the ideal.
Time frame: at 14 days
Visual Acuity - Left Eye
This outcome measures visual acuity in logMARs. logMAR is the logarithm of the minimum angle of resolution (logMAR. The ideal is 0.0 and represents 20/20 Snellen acuity. logMar values \> 0.00 indicate vision poorer than the ideal and values \<0.00 indicate vision greater than the ideal.
Time frame: at 14 days
Intraocular Pressure (IOP)
Time frame: from baseline to 14 days
| Milestone | High Dose Bimatoprost Punctal Plug | Low Dose Bimatoprost Punctal Plug | Placebo |
|---|---|---|---|
| Started | 19 | 16 | 20 |
| Completed | 16 | 15 | 19 |
| Not completed | 3 | 1 | 1 |
| Withdrew: Failed plug insertion | 3 | 1 | 0 |
| Withdrew: Protocol violation | 0 | 0 | 1 |
| mmHg | High Dose Bimatoprost Punctal Plug | Low Dose Bimatoprost Punctal Plug | Placebo |
|---|---|---|---|
| Intraocular Pressure (IOP) | -1.9 ± 2.3 | -2.2 ± 3.5 | -1.3 ± 3.6 |
This outcome measures visual acuity in logMARs. logMAR is the logarithm of the minimum angle of resolution (logMAR). The ideal is 0.0 and represents 20/20 Snellen acuity. logMar values \> 0.00 indicate vision poorer than the ideal and values \<0.00 indicate vision greater than the ideal.
| logMAR units | High Dose Bimatoprost Punctal Plug | Low Dose Bimatoprost Punctal Plug | Placebo |
|---|---|---|---|
| Visual Acuity - Right Eye | 0.015 ± 0.046 | -0.044 ± 0.092 | -0.012 ± 0.044 |
This outcome measures visual acuity in logMARs. logMAR is the logarithm of the minimum angle of resolution (logMAR. The ideal is 0.0 and represents 20/20 Snellen acuity. logMar values \> 0.00 indicate vision poorer than the ideal and values \<0.00 indicate vision greater than the ideal.
| logMARs | High Dose Bimatoprost Punctal Plug | Low Dose Bimatoprost Punctal Plug | Placebo |
|---|---|---|---|
| Visual Acuity - Left Eye | -0.011 ± 0.081 | -0.008 ± 0.101 | -0.019 ± 0.044 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| High Dose Bimatoprost Punctal Plug | — | 1/16 (6.3%) | 13/16 (81.3%) |
| Low Dose Bimatoprost Punctal Plug | — | 0/15 (0%) | 11/15 (73.3%) |
| Placebo | — | 0/20 (0%) | 11/20 (55%) |
| Event | High Dose Bimatoprost Punctal Plug | Low Dose Bimatoprost Punctal Plug | Placebo |
|---|---|---|---|
| cerebrovascular accidentNervous system disorders | 1/16 | 0/15 | 0/20 |
| Event | High Dose Bimatoprost Punctal Plug | Low Dose Bimatoprost Punctal Plug | Placebo |
|---|---|---|---|
| Foreign body sensationEye disorders | 8/16 | 5/15 | 3/20 |
| Eye painEye disorders | 6/16 | 2/15 | 1/20 |
| Conjunctival hyperaemiaEye disorders | 3/16 | 5/15 | 2/20 |
| lacrimation increasedEye disorders | 2/16 | 5/15 | 4/20 |
| abnormal sensation in eyesEye disorders | 5/16 | 3/15 | 4/20 |
| corneal erosionEye disorders | 5/16 | 2/15 | 0/20 |
| eyelid painEye disorders | 5/16 | 2/15 | 1/20 |
| inflammation of lacrimal passageEye disorders | 5/16 | 4/15 | 2/20 |
| eyelid margin crustingEye disorders | 4/16 | 1/15 | 2/20 |
| dry eyeEye disorders | 3/16 | 2/15 | 0/20 |
| Age, Continuous(years) | High Dose Bimatoprost Punctal Plug | Low Dose Bimatoprost Punctal Plug | Placebo | Total |
|---|---|---|---|---|
| Mean | 66.7 ± 13.4 | 64.6 ± 12.9 | 64.5 ± 10.6 | 65.2 ± 12.0 |
| Sex: Female, Male(Participants) | High Dose Bimatoprost Punctal Plug | Low Dose Bimatoprost Punctal Plug | Placebo | Total |
|---|---|---|---|---|
| Female | 9 | 9 | 13 | 31 |
| Male | 7 | 6 | 7 | 20 |
This study is completed, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.
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Vistakon Pharmaceuticals