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

Study Overview
=================
Brief Summary
-----------------
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).

Official Title
-----------------
Efficacy, Tolerability and Comfort of 0.3% Hypromellose Eyedrops in the Pre- and Post-Operative Treatment of Patients Undergoing LASIK Surgery

Conditions
-----------------
Dry Eye

Intervention / Treatment
-----------------
* Drug: Pre-LASIK 0.3% hypromellose
* Drug: Post-LASIK 0.3% hypromellose


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 35 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pre-LASIK 0.3% hypromellose<br> | Drug: Pre-LASIK 0.3% hypromellose<br>* 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.<br>|
| Active Comparator: Post-LASIK 0.3% hypromellose<br> | Drug: Post-LASIK 0.3% hypromellose<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline (Pre-LASIK surgery), Day 1, Day 7 and Day 30 post-LASIK surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Baseline (Pre-LASIK surgery), Day 1, Day 7 and Day 30 post-LASIK surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Post LASIK dry eye, Pre LASIK dry eye, Hypromellose