A Study to Compare the Safety and Efficacy of a New Eye Drop Formulation With REFRESH PLUS® in Participants Following LASIK Refractive Surgery

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

PHASE3

Total Enrollment

148 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-20

Study Completion Date

2014-08-18

Brief Summary

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

This study will compare the safety and efficacy of a new eye drop formulation with REFRESH PLUS® in participants following LASIK surgery.

Related Clinical Trials

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

Efficacy and Necessity of Anti-inflammatory Drops After Laser Peripheral Iridotomy

NCT02955641

Glaucoma, Closed-Angle Glaucoma, Narrow-Angle Glaucoma, Angle-Closure

UNKNOWN NA

Measurement of Antioxidant Activity on Postoperative Inflammation in Patients Undergoing Ophthalmic Surgery

NCT05905237

Cataract Myopia

COMPLETED

Clinical Investigation of Visual Acuity in Contact Lens Wearers After Instillation of a Lipid- Based Lubricating Eye Drop

NCT06131476

Visual Acuity

COMPLETED PHASE1

Safety and Efficacy of KPI-121 in Subjects With Postsurgical Inflammation

NCT02163824

Ocular Infections, Irritations and Inflammations

COMPLETED PHASE3

Comparison of Acular LS Versus Nevanac for Pain Control in Eyes Undergoing PRK

NCT00347204

Myopia Hyperopia

COMPLETED PHASE4

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.

Bilateral LASIK Surgery

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.

New Eye Drop Formulation

1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation in each eye as per protocol for 90 days.

Group Type EXPERIMENTAL

carboxymethylcellulose sodium based new eye drop formulation

Intervention Type DRUG

1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation in each eye as per protocol for 90 days.

REFRESH PLUS®

1 to 2 drops carboxymethylcellulose sodium based (REFRESH PLUS®) eye drops in each eye as per protocol for 90 days.

Group Type ACTIVE_COMPARATOR

carboxymethylcellulose sodium based eye drops

Intervention Type DRUG

1 to 2 drops carboxymethylcellulose sodium based (REFRESH PLUS®) eye drops in each eye as per protocol for 90 days.

Interventions

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

carboxymethylcellulose sodium based new eye drop formulation

1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation in each eye as per protocol for 90 days.

Intervention Type DRUG

carboxymethylcellulose sodium based eye drops

1 to 2 drops carboxymethylcellulose sodium based (REFRESH PLUS®) eye drops in each eye as per protocol for 90 days.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

REFRESH PLUS®

Eligibility Criteria

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

Inclusion Criteria

-Patients scheduled for LASIK surgery in both eyes.

Exclusion Criteria

* Any systemic medication use within 3 months of screening (including over the counter, herbal, prescription, or nutritional supplement) which may affect dry eye or vision
* Use of topical eye medication other than prescribed for use in pre- or post-operative care
* Use of RESTASIS® or other topical ophthalmic cyclosporine product within 6 months prior to Screening
* Eye infection, inflammation, or allergy
* Soft contact lenses in the previous 7 days or rigid contact lenses in the previous 30 days prior to LASIK surgery.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes