Exploratory Trial to Evaluate the Efficacy and Safety of D565H Twice Daily Versus D565 Once Daily

Chong Kun Dang

Status and phase: Unknown; Phase 2

Conditions: Glaucoma, Primary Open Angle; Ocular Hypertension

Treatments: Drug: D565H(Latanoprost 25㎍/㎖); Drug: D565(Latanoprost 50㎍/㎖)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03067415

171GLC16020

Details and patient eligibility

About

Exploratory trial to evaluate the efficacy and safety of D565H twice daily versus D565 once daily.

Full description

A Multi center, Randomized, Double-blind, Parallel design, Exploratory trial to evaluate the efficacy and safety of D565H twice daily versus D565 once daily in primary open angle glaucoma or ocular hypertension patients.

Enrollment: 98 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. More than the age of 19 years old
2. Subjects who has primary Open-Angle Glaucoma or Ocular Hypertension
3. Subjects who sign on an informed consent form willingly

Exclusion criteria

1. Subjects with IOP(Intraocular Pressure) measured at Visit 1 and Visit 2(AM 09:00) above 35 mmHg at more than one eye

2. Subjects with a maximum corrected visual acuity of less or than 0.3 in the selected evaluation eye at visit 2

3. Subjects who were diagnosed as below with monocular or both eye

   • Acute or Chronic Closed-Angle Glaucoma
   • Secondary Glaucoma
   • Pseudoexfoliation Glaucoma
   • Neovascular Glaucoma
   • aphakia
   • phacocyst capsular torn intraocular lens

4. Subjects with significant eye symptoms/signs(Abscesses, diplopia) or severe visual field impairment(Mean Deviation -25dB or more)

5. Subjects with severe dry eye syndrome or progressive retinal disease(Retinal degeneration, Diabetic retinopathy, Retinal detachment, Macular edema)

6. Subjects with inflammatory/infectious eye disease and active eye disease within the last 3 months

7. Subjects who have medical history following

   • Glaucoma surgery
   • Subjects with significant history of ocular trauma during the last 6 months, or who underwent surgical ophthalmic surgery
   • Subjects who received topical or systemic steroids within the last 6 months

8. Subjects who wore need to wear contact lenses during the study

9. Subjects who have drug interaction with the investigational product, have a significant effect on the intraocular pressure, or who may have an effect on the clinical trial results

10. Subjects with known hypersensitivity to investigational product

11. Women who are nursing, pregnant or planning pregnancy during the study

12. Subjects with bronchial asthma or history

13. Subjects who have received any other investigational product within 1 month prior to the first dosing

14. Impossible subjects who participate in clinical trial by investigator's decision

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

98 participants in 2 patient groups

D565H(Latanoprost 25㎍/㎖)

Experimental group

Description:

D565H(Latanoprost 25㎍/㎖)

Treatment:

Drug: D565(Latanoprost 50㎍/㎖)

Drug: D565H(Latanoprost 25㎍/㎖)

D565(Latanoprost 50㎍/㎖)

Active Comparator group

Description:

D565(Latanoprost 50㎍/㎖)

Treatment:

Drug: D565(Latanoprost 50㎍/㎖)

Drug: D565H(Latanoprost 25㎍/㎖)