A Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution in Patients With POAG or OHT

• Sponsor: Santen Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01654484
• Collaborator: (none)
• Enrollment: 60
• Locations: 10
• Arms: 8
• Duration (Months): 4
• Patients Per Site: 6
• Patients Per Site Per Month: 1.5

Study Details

Study Description

Brief Summary

The purpose of this study is to investigate the safety and efficacy of up to three concentrations of DE-117 ophthalmic solution (Low Dose, Medium Dose, and High Dose) as monotherapy and as adjunctive therapy (DE-117 ophthalmic solution with 0.0015% tafluprost) in subjects with primary open-angle glaucoma or ocular hypertension.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma and Ocular Hypertension	Drug: DE-117; Drug: 0.0015% tafluprost; Drug: DE-117 and 0.0015% tafluprost; Drug: Placebo	Phase 1/Phase 2

Detailed Description

This is a two stage study.

Stage One will explore the dose response of three concentrations of DE-117 as monotherapy compared with 0.0015% tafluprost and placebo. The safety and efficacy of DE-117 as adjunctive therapy (with 0.0015% tafluprost) compared with 0.0015% tafluprost and placebo will also be evaluated. In addition, the additive effect of adjunctive therapy of each concentration will be compared with the corresponding monotherapy concentration.

Stage Two will assess the safety and efficacy of the optimal DE-117 concentration as monotherapy compared with 0.0015% tafluprost. The safety and efficacy of the optimal DE-117 concentration as adjunctive therapy (with 0.0015% tafluprost) compared with DE-117 monotherapy and 0.0015% tafluprost will also be evaluated.

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: A Phase I/II, Randomized, Observer-masked, Placebo-and Active-controlled, Parallel-group, Multi-center Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution in Subjects With Primary Open-angle Glaucoma or Ocular Hypertension
• Study Start Date: Jul 1, 2012
• Actual Primary Completion Date: Nov 1, 2012
• Actual Study Completion Date: Nov 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Low Dose DE-117 Monotherapy	Drug: DE-117; Ophthalmic Solution, QD, 28 Days
Experimental: Medium Dose DE-117 Monotherapy	Drug: DE-117; Ophthalmic Solution, QD, 28 Days
Experimental: High Dose DE-117 Monotherapy	Drug: DE-117; Ophthalmic Solution, QD, 28 Days
Experimental: Low Dose DE-117 and 0.0015% tafluprost Adjunctive Therapy	Drug: DE-117 and 0.0015% tafluprost; Ophthalmic Solutions, QD, 28 days
Experimental: Med. Dose DE-117 and 0.0015% tafluprost Adjunctive Therapy	Drug: DE-117 and 0.0015% tafluprost; Ophthalmic Solutions, QD, 28 days
Experimental: High Dose DE-117 and 0.0015% tafluprost Adjunctive Therapy	Drug: DE-117 and 0.0015% tafluprost; Ophthalmic Solutions, QD, 28 days
Active Comparator: 0.0015% tafluprost Monotherapy	Drug: 0.0015% tafluprost; Ophthalmic Solution, QD, 28 days
Placebo Comparator: Placebo Monotherapy	Drug: Placebo; Ophthalmic Solution, QD, 28 days

Outcome Measures

Primary Outcome Measures

1. Change from baseline in intraocular pressure (IOP) on Day 29 at each scheduled time point [Day 28 T0 (08:00 ±30 mins), T0+2 hrs, T0+4 hrs, T0+8 hrs]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Male or Female, 18 years of age or older

2. Current diagnosis of primary open-angle glaucoma or ocular hypertension in both eyes

3. Qualifying intraocular pressure (IOP) in at least one eye at Baseline

Exclusion Criteria:

1. Closed/barely open anterior chamber angle or a history of acute angle closure in either eye

2. Anticipate the need to initiate or modify medication (systemic or topical) that is known to affect intraocular pressure (IOP) during the study period

3. Females who are pregnant, nursing or planning a pregnancy

4. Presence of any abnormality or significant illness that could be expected to interfere with the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Santen Investigational Site	Newport Beach	California	United States	92663
2	Santen Investigational Site	Deerfield Beach	Florida	United States	33064
3	Santen Investigational Site	Largo	Florida	United States	33773
4	Santen Investigational Site	Morrow	Georgia	United States	30260
5	Santen Investigational Site	Roswell	Georgia	United States	30076
6	Santen Investigational Site	Rochester	New York	United States	14618
7	Santen Investigational Site	Cleveland	Ohio	United States	44115
8	Santen Investigational Site	Austin	Texas	United States	78731
9	Santen Investigational Site	Fort Worth	Texas	United States	76102
10	Santen Investigational Site	San Antonio	Texas	United States	78240

Sponsors and Collaborators

• Santen Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Santen Inc.
• ClinicalTrials.gov Identifier: NCT01654484
• Other Study ID Numbers: 33-001
• First Posted: Jul 31, 2012
• Last Update Posted: Apr 18, 2018
• Last Verified: Apr 1, 2018

• Additional relevant MeSH terms: Glaucoma; Ocular Hypertension; Hypertension

Study Results

No Results Posted as of Apr 18, 2018