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

Novartis Pharmaceuticals170 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

170

Conditions

Dry Eye

Interventions

Pre-LASIK 0.3% hypromelloseDRUG

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% hypromelloseDRUG

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.

Eligibility

Sex: ALLMin age: 21 YearsMax age: 35 Years

Medical Language ↔ Plain English

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

Locations (1)

Novartis Investigative Site

Delhi, India

Outcomes

Primary Outcomes

Ocular Comfort Level From Baseline to End of Study

Patients rated their ocular comfort on a scale of 0 to 10 on the following parameters: Burning sensation, foreign body sensation, itching, watering of eyes, dryness of eyes, and photophobia. A higher score indicated greater discomfort. A negative change score indicated improvement.

Time frame: Baseline (Pre-LASIK surgery), Day 1, Day 7 and Day 30 post-LASIK surgery

Secondary Outcomes

Tear Breakup Time From Baseline to End of Study

The time required for dry spots to appear on the corneal surface after blinking. Sodium fluorescein dye is added to the eye and the tear film is observed under a slit lamp while the patient avoids blinking until tiny dry spots develop. The longer it takes, the more stable the tear film. A short tear breakup time is a sign of a poor tear film. Generally, \>10 seconds is thought to be normal, 5 to 10 seconds marginal, and \<5 seconds low (with high likelihood of dry eye symptoms), ie, a shorter time indicates greater eye dryness. A positive change score indicates improvement.

Time frame: Baseline (Pre-LASIK surgery), Day 1, Day 7 and Day 30 post-LASIK surgery

Results of Schirmer's Test From Baseline to End of Study

Schirmer's test determines tear production, and whether the eye produces enough tears to keep it moist. A small strip of filter paper is inserted inside the lower eyelid of each eye and the eyes are closed for 5 minutes. The paper is then removed and the length of paper that is moist is measured. A young person normally moistens 15 mm of the paper. The shorter the length of moist paper, the dryer the eyes. A positive change score indicates improvement.

Time frame: Baseline (Pre-LASIK surgery), Day 1, Day 7 and Day 30 post-LASIK surgery

Data from ClinicalTrials.gov

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