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CompletedNCT02108288Updated Apr 22, 2015Results posted

Pharmacokinetic Study of OPC-1085EL Ophthalmic Solution in Healthy Male Adult Volunteers

A Phase 1 interventional study of OPC-1085EL ophthalmic solution and Carteolol long-acting ophthalmic solution in Glaucoma and Ocular Hypertension, sponsored by Otsuka Pharmaceutical Co., Ltd.. Completed at 1 site in Japan. Open to male participants aged 20 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-04-22.

Sponsored by Otsuka Pharmaceutical Co., Ltd. · Phase 1 and Interventional

Phase
Phase 1
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
20 Years to 45 Years
Sex
Male
01

Study summary

OPC-1085EL ophthalmic solution, carteolol long-acting ophthalmic solution or latanoprost ophthalmic solution are administered once daily for 7 days and the effect on the blood concentration of carteolol and latanoprost in OPC-1085EL ophthalmic solution by formulating the combination drug will be determined.

02

Conditions studied

  • Glaucoma
  • Ocular Hypertension

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03

In context

Ocular Hypertension

649 studies on the registry are indexed under Ocular Hypertension; 48 are open to participants now.

This study's enrollment of 30 is below the median of 120 across 510 interventional studies indexed under Ocular Hypertension.

Browse Ocular Hypertension studies →

Lead sponsor

Otsuka Pharmaceutical Co., Ltd. is the lead sponsor of 140 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 45 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • Subjects who are considered medically healthy per investigator's judgment

Exclusion criteria

Exclusion Criteria:

  • Subjects with ocular conditions as defined by the protocol
  • Subjects with intraocular pressure: \<10 or ≥22 mmHg
05

Study design

Phase
Phase 1
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    OPC-1085EL ophthalmic solution

    Once daily

    Drug: OPC-1085EL ophthalmic solution

  • Active comparator
    Carteolol long-acting ophthalmic solution

    Once daily

    Drug: Carteolol long-acting ophthalmic solution

  • Active comparator
    Latanoprost ophthalmic solution

    Once daily

    Drug: Latanoprost ophthalmic solution

Interventions

  • DrugOPC-1085EL ophthalmic solution
  • DrugCarteolol long-acting ophthalmic solution
  • DrugLatanoprost ophthalmic solution
06

What researchers measure

Primary outcomes

  1. Cmax of Carteolol

    Time frame: Day 1 and Day 7

  2. Cmax of Latanoprost Acid

    Time frame: Day 1 and Day 7

Secondary outcomes

  1. Tmax of Carteolol

    Time frame: Day 1 and Day 7

  2. Tmax of Latanoprost Acid

    Time frame: Day 1 and Day 7

07

Results

Posted Apr 2, 2015

Participant flow

Participant flow — Overall Study
MilestoneOPC-1085EL Ophthalmic SolutionCarteolol Long-acting Ophthalmic SolutionLatanoprost Ophthalmic Solution
Started101010
Completed101010
Not completed000

Outcome measures

PrimaryCmax of Carteolol
Time frame:
Day 1 and Day 7
Reported as:
Mean · ng/mL
Cmax of Carteolol
ng/mLOPC-1085EL Ophthalmic SolutionCarteolol Long-acting Ophthalmic Solution
Day 10.8558 ± 0.26580.9984 ± 0.4832
Day 71.174 ± 0.30851.627 ± 0.5001
PrimaryCmax of Latanoprost Acid
Time frame:
Day 1 and Day 7
Reported as:
Mean · pg/mL
Cmax of Latanoprost Acid
pg/mLOPC-1085EL Ophthalmic SolutionLatanoprost Ophthalmic Solution
Day 119.77 ± 10.1321.22 ± 10.16
Day 718.47 ± 8.91317.48 ± 8.892
SecondaryTmax of Carteolol
Time frame:
Day 1 and Day 7
Reported as:
Median · h
Tmax of Carteolol
hOPC-1085EL Ophthalmic SolutionCarteolol Long-acting Ophthalmic Solution
Day 10.25 (0.25 to 4.00)0.25 (0.25 to 23.92)
Day 70.25 (0.25 to 4.00)0.38 (0.25 to 24.00)
SecondaryTmax of Latanoprost Acid
Time frame:
Day 1 and Day 7
Reported as:
Median · min
Tmax of Latanoprost Acid
minOPC-1085EL Ophthalmic SolutionLatanoprost Ophthalmic Solution
Day 110 (5 to 10)10 (5 to 10)
Day 75 (5 to 10)10 (5 to 10)

Adverse events

Collected over Up to 24 days from date of informed consent. Non-serious events are listed at a 2% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
OPC-1085EL Ophthalmic Solution—0/10 (0%)6/10 (60%)
Carteolol Long-acting Ophthalmic Solution—0/10 (0%)4/10 (40%)
Latanoprost Ophthalmic Solution—0/10 (0%)8/10 (80%)
Most frequent other events
Most frequent other events
EventOPC-1085EL Ophthalmic SolutionCarteolol Long-acting Ophthalmic SolutionLatanoprost Ophthalmic Solution
Conjunctival hyperaemiaEye disorders6/103/108/10
Corneal disorderEye disorders0/100/103/10
Accommodation disorderEye disorders0/101/100/10
Eye pruritusEye disorders0/100/101/10

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)OPC-1085EL Ophthalmic SolutionCarteolol Long-acting Ophthalmic SolutionLatanoprost Ophthalmic SolutionTotal
<=18 years0000
Between 18 and 65 years10101030
>=65 years0000
Age, Continuous
Age, Continuous(years)OPC-1085EL Ophthalmic SolutionCarteolol Long-acting Ophthalmic SolutionLatanoprost Ophthalmic SolutionTotal
Mean26.7 ± 5.725.5 ± 3.024.0 ± 2.825.4 ± 4.1
Sex: Female, Male
Sex: Female, Male(Participants)OPC-1085EL Ophthalmic SolutionCarteolol Long-acting Ophthalmic SolutionLatanoprost Ophthalmic SolutionTotal
Female0000
Male10101030
Region of Enrollment
Region of Enrollment(participants)OPC-1085EL Ophthalmic SolutionCarteolol Long-acting Ophthalmic SolutionLatanoprost Ophthalmic SolutionTotal
Japan10101030
08

Study locations

1 site
  • Kansai Region, Japan
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 22, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02108288
Lead sponsor
Otsuka Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Apr 9, 2014
Start date
Apr 2014
Primary completion
May 2014
Completion
Aug 2014
Results posted
Apr 2, 2015
Last update
Apr 22, 2015

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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