Efficacy, Tolerability, and Comfort of 0.3% Hypromellose Eyedrops in Patients Undergoing LASIK 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

PHASE4

Total Enrollment

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-01

Study Completion Date

2010-01-01

Brief Summary

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

This study is designed to assess the tolerability and comfort of peri-operative 0.3% hypromellose eye drops in LASIK surgery patients and to assess whether pre-operative 0.3% hypromellose eye drops add to post-operative comfort in LASIK surgery patients compared to control (no pre-operative lubricant).

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

Safety and Efficacy of 2 Concentrations of Lubricin vs Sodium Hyaluronate in Ocular Discomfort After Refractive Surgery.

NCT03031327

Ocular Discomfort

COMPLETED NA

Cross-Over Evaluation of Two Lubricating Eye Drops

NCT00493662

Dry Eye

COMPLETED PHASE4

Topical Proparacaine Eye Drops to Improve the Experience of Patients Undergoing Intravitreal Injections

NCT02951351

COMPLETED NA

The Effect of Ophthalmic Solutions on Contact Lenses Used After Surgery for Congenital Cataract Investigated in Vivo

NCT03125785

Congenital Cataract

UNKNOWN

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

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

NONE

Study Groups

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

Pre-LASIK 0.3% hypromellose

Group Type EXPERIMENTAL

Pre-LASIK 0.3% hypromellose

Intervention Type DRUG

Patients self-administered GenTeal eye drops qid (quarter in die, 4 times a day) starting 5 days prior to LASIK surgery and continuing through 1 month after LASIK surgery.

Post-LASIK 0.3% hypromellose

Group Type ACTIVE_COMPARATOR

Post-LASIK 0.3% hypromellose

Intervention Type DRUG

Patients self-administered GenTeal eye drops qid (quarter in die, 4 times a day) starting on the day of LASIK surgery and continuing through 1 month after surgery.

Interventions

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

Pre-LASIK 0.3% hypromellose

Patients self-administered GenTeal eye drops qid (quarter in die, 4 times a day) starting 5 days prior to LASIK surgery and continuing through 1 month after LASIK surgery.

Intervention Type DRUG

Post-LASIK 0.3% hypromellose

Patients self-administered GenTeal eye drops qid (quarter in die, 4 times a day) starting on the day of LASIK surgery and continuing through 1 month after surgery.

Intervention Type DRUG

Eligibility Criteria

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

Inclusion Criteria

* Age 21 - 35
* Both sexes
* Seeking LASIK surgery at the Refractive Surgery Centre
* Meeting all established criteria for appropriateness for LASIK established by the treating center

Exclusion Criteria

* Any corneal pathology including scars, prior herpes keratitis, prior corneal transplant
* Any immuno-compromised state including cancer, HIV infection, Hepatitis B or C, or diabetes mellitus
* Requirement for any eye-drops for any reason (eg, dry eye or conjunctivitis) within 3 months from time of enrollment
* Anticipated refusal or inability to undergo planned post-operative visits or assessment
* Failure to meet all established criteria for appropriateness for LASIK

Minimum Eligible Age

21 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No