Study to Assess the Safety and Efficacy of BOL-303242-X Ophthalmic Suspension in Dry Eye Syndrome

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

356 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2011-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The objective of this study is to identify the concentration and daily dosing frequency of BOL-303242-X ophthalmic suspension in treating dry eye syndrome over a 12 week dosing period.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study to Assess Efficacy and Safety of HL036 in Subjects With Dry Eyes

NCT03846453

Dry Eye

COMPLETED PHASE3

Systemic Pharmacokinetics of BOL-303224-A

NCT00407589

Conjunctivitis, Bacterial

COMPLETED PHASE1

Phase 2, Multi-center, Randomized, Double- Masked and Placebo-Controlled Study of YP-P10 Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye (ICECAP 1)

NCT05467293

Dry Eye

COMPLETED PHASE2

A Study of RX-10045 in the Treatment of Dry Eye Disease

NCT01675570

Dry Eye Syndrome

COMPLETED PHASE2

A Randomized, Double Masked, Clinical Study of Subjects With Dry Eye Syndrome

NCT03162783

Dry Eye Syndromes

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dry Eye Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

0.3% BOL-303242-X ophthalmic suspension

Group Type EXPERIMENTAL

0.3% BOL-303242-X ophthalmic suspension

Intervention Type DRUG

0.3% BOL-303242-X ophthalmic suspension BID for 12 weeks.

2% BOL-303242-X ophthalmic suspension

Group Type EXPERIMENTAL

2% BOL-303242-X ophthalmic suspension

Intervention Type DRUG

2% BOL-303242-X ophthalmic suspension BID for 12 weeks.

Vehicle

Vehicle twice daily (BID)

Group Type PLACEBO_COMPARATOR

Placebo Comparator: Vehicle

Intervention Type DRUG

Placebo Comparator: Vehicle BID for 12 weeks.

1% BOL-303242-X ophthalmic suspension

Group Type EXPERIMENTAL

1% BOL-303242-X ophthalmic suspension

Intervention Type DRUG

1% BOL-303242-X ophthalmic suspension BID for 12 weeks.

2% BOL-303242-X ophthalmic suspension in the morning

2% BOL-303242-X ophthalmic suspension in the morning (AM) and vehicle in the afternoon (PM)

Group Type EXPERIMENTAL

2% BOL-303242-X ophthalmic suspension AM

Intervention Type DRUG

2% BOL-303242-X ophthalmic suspension once daily (QD) AM and vehicle QD in PM for 12 weeks.

2% BOL-303242-X ophthalmic suspension PM

Vehicle in the AM and 2% BOL-303242-X ophthalmic suspension in the PM.

Group Type EXPERIMENTAL

2% BOL-303242-X ophthalmic suspension PM

Intervention Type DRUG

Vehicle QD AM and 2% BOL-303242-X ophthalmic suspension QD in PM for 12 weeks.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

0.3% BOL-303242-X ophthalmic suspension

0.3% BOL-303242-X ophthalmic suspension BID for 12 weeks.

Intervention Type DRUG

2% BOL-303242-X ophthalmic suspension

2% BOL-303242-X ophthalmic suspension BID for 12 weeks.

Intervention Type DRUG

Placebo Comparator: Vehicle

Placebo Comparator: Vehicle BID for 12 weeks.

Intervention Type DRUG

1% BOL-303242-X ophthalmic suspension

1% BOL-303242-X ophthalmic suspension BID for 12 weeks.

Intervention Type DRUG

2% BOL-303242-X ophthalmic suspension AM

2% BOL-303242-X ophthalmic suspension once daily (QD) AM and vehicle QD in PM for 12 weeks.

Intervention Type DRUG

2% BOL-303242-X ophthalmic suspension PM

Vehicle QD AM and 2% BOL-303242-X ophthalmic suspension QD in PM for 12 weeks.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Subjects who have a diagnosis of dry eye disease.
* Intraocular pressure (IOP) ≤28 mmHg with no IOP lowering medications.
* Subjects who are willing and able to refrain from using contact lenses during the study.

Exclusion Criteria

* Subjects with known hypersensitivity or contraindication to any component of the study medication.
* Subjects who are expected to require concurrent treatment with ophthalmic medications (prescription or over the counter).
* Subjects who are expected to require treatment with corticosteroids during the study.
* Subjects who have used topical or systemic isotretinoin, cyclosporine, or retinoid therapies within 30 days prior to the screening visit.
* Subjects who have undergone any type of ocular surgery within three months prior to screening.
* Lacrimal punctal occlusion (plugs or cautery) within 2 months of Screening Visit.
* Subjects with a history or presence of chronic generalized systemic or ocular disease that the Investigator feels might increase the risk to the subject or confound the result of the study.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No