Normal Tension Glaucoma, Ocular Hypertension, Primary Open Angle Glaucoma
Conditions
Keywords
Glaucoma, High intraocular eye pressure, Normal tension open angle glaucoma
Brief summary
The objective of this study is to evaluate the safety and effectiveness of Direct Selective Laser Trabeculoplasty (DSLT) in ethnic Chinese participants with Primary Open Angle Glaucoma (POAG), Ocular Hypertension (OHT), or Normal Tension Glaucoma (NTG).
Detailed description
After informed consent is obtained, potential study participants will undergo a hypotensive medication washout period as applicable. Patients will then be re-assessed for eligibility and treated with DSLT if they meet the inclusion/exclusion criteria. The first 5 patients will be treated 360 degrees with laser energy of 1.2 millijoule (mJ) (Group 1). If all 5 Group 1 patients pass the pre-defined safety endpoint at Week 1, then the next 40 patients will be treated 360 degrees with laser energy of 1.8 mJ (Group 2). Patients will attend one treatment visit and up to 9 follow-up visits, remotely or at the clinic. Individual duration of participation is approximately 12 months.
Interventions
DEVICEExternal Automatic Glaucoma Laser
Trans-limbal, direct selective laser trabeculoplasty (DSLT) instrument that directs laser energy through the sclera around the limbus overlying the trabecular meshwork and treats 360 degrees of the angle is treated simultaneously
Surgical procedure that utilizes a laser to improve fluid drainage in the eye and reduce intraocular pressure
Sponsors
BelkinVision
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Chinese ethnicity with corrected visual acuity greater than 6/18 in both eyes. * Diagnosed with mild to moderate primary open angle glaucoma, ocular hypertension, or normal tension open angle glaucoma. * Willing and able to participate in a 12-month study, comply with the study procedures, and adhere to the follow-up schedule. * Capable of giving informed consent. * Other protocol-specified inclusion criteria may apply. Key
Exclusion criteria
* Eye conditions as specified in the protocol. * Use of medications as specified in the protocol. * Unable to provide a reliable visual field test. * Women who are pregnant or may become pregnant during the study. * Prior surgery in the study eye. * In a vision-dependent profession such as pilot or commercial driver. * Other protocol-specified
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change from Baseline in IOP at Month 6 | Baseline (Day -7 to 0) (post washout and pretreatment), Month 6 | Intraocular pressure (IOP) will be assessed with Goldmann applanation tonometry and recorded in millimeters mercury (mmHg). Change from baseline is defined as the difference between baseline (washed out for medicated patients) IOP and (washed out for medicated patients) IOP measured at Month 6 for each participant enrolled in the study. A negative change from baseline will represent an improvement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Percent Reduction from Baseline in IOP at Month 6 and Month 12 | Baseline (Day -7 to 0) (post washout and pretreatment), Month 6, Month 12 | Intraocular pressure (IOP) will be assessed with Goldmann applanation tonometry and recorded in millimeters mercury (mmHg). Change from baseline is defined as the difference between baseline (washed out for medicated patients) IOP and (washed out for medicated patients) IOP measured at the respective timepoints (Month 6 and Month 12). A positive percent reduction will represent an improvement. |
| Proportion of Subjects with at least 20 percent reduction in IOP from Baseline in IOP for POAG and OHT and at least 15 percent reduction in IOP for NTG at Month 6 with no Secondary Surgical Intervention (SSI) or Inability to Washout | Baseline (Day -7 to 0) (post washout and pretreatment), Month 6, Month 12 | Intraocular pressure (IOP) will be assessed with Goldmann applanation tonometry and recorded in millimeters mercury (mmHg). A secondary surgical intervention (SSI) is defined as a procedure in addition to DSLT that is conducted to manage/lower IOP. A higher proportion with the specified reduction will represent an improvement. |
| Change from Baseline in Number of Glaucoma Medications at Month 6 and Month 12 | Screening (Day -45 to -1) (prewashout and pretreatment)/Visit 1 (Day 0) (pretreatment), Month 6, Month 12 | The number of glaucoma-related medications in use will be recorded. For medicated subjects, the Screening visit is considered baseline. For naïve (unmedicated) subjects, Visit 1 is considered baseline. |
Countries
China, Singapore
Contacts
STUDY_DIRECTORDorit Raz Prag
Alcon Research, LLC
Outcome results
None listed