Double-Masked Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution Once Daily and Twice Daily in Subjects With Primary Open-Angle Glaucoma SPECTRUM 6
| Status: | Recruiting |
|---|---|
| Conditions: | High Blood Pressure (Hypertension), Ocular |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Ophthalmology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/3/2019 |
| Start Date: | January 28, 2019 |
| End Date: | June 17, 2019 |
| Contact: | Santen Inc. Clinical Operations |
| Email: | clinicaltrials@santen.com |
| Phone: | (415)-268-9199 |
A Randomized, Double-Masked, Parallel-Group, Multicenter Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution 0.002% Once Daily and Twice Daily in Subjects With Primary Open-Angle Glaucoma or Ocular Hypertension SPECTRUM 6 Study.
This is a randomized, double-masked, parallel-group, multi-center study. Subjects diagnosed
with POAG or OHT who meet eligibility criteria at Visit 1 (Screening) will wash out their
current topical IOP lowering medication(s), if any. After completing the required washout
period, subjects will return for Visit 2 (Baseline, Day 1). Subjects who meet all eligibility
criteria at Visit 2 (Baseline, Day 1) will be randomized to receive study medication for up
to 6 weeks.
Approximately 100 subjects with POAG or OHT will be randomized in a 1:1 ratio to either:
- DE-117 ophthalmic solution 0.002% QD (Once Daily)
- DE-117 ophthalmic solution 0.002% BID (Twice Daily)
This study will consist of a screening period of up to 35 days including a washout period of
up to 28 days (+ 7 days window), and a 6-week double-masked treatment period.
with POAG or OHT who meet eligibility criteria at Visit 1 (Screening) will wash out their
current topical IOP lowering medication(s), if any. After completing the required washout
period, subjects will return for Visit 2 (Baseline, Day 1). Subjects who meet all eligibility
criteria at Visit 2 (Baseline, Day 1) will be randomized to receive study medication for up
to 6 weeks.
Approximately 100 subjects with POAG or OHT will be randomized in a 1:1 ratio to either:
- DE-117 ophthalmic solution 0.002% QD (Once Daily)
- DE-117 ophthalmic solution 0.002% BID (Twice Daily)
This study will consist of a screening period of up to 35 days including a washout period of
up to 28 days (+ 7 days window), and a 6-week double-masked treatment period.
Inclusion Criteria:
Provide signed written informed consent
- Have a diagnosis of POAG or OHT in both eyes, or one eye with POAG and the other with
OHT.
- Qualifying corrected visual acuity in each eye
- Qualifying central corneal thickness in each eye
- Qualifying Day 1 IOP measurement at 3 time-points in both eyes
- Qualifying Anterior chamber angle
Exclusion Criteria:
- History of ocular surgery specifically intended to lower IOP
- Subjects who cannot safely discontinue use of ocular hypotensive medications during
the wait/washout period
- Advanced glaucoma in either eye
- Any corneal abnormality or other condition interfering with or preventing reliable
Goldmann applanation tonometry
- Any ocular surgery or ocular laser treatment within 180 days prior to Screening and
throughout the study in either eye
- Females who are pregnant, nursing, or planning a pregnancy
We found this trial at
13
sites
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