Efficacy, Tolerability, and Comfort of 0.3% Hypromellose Eyedrops in Patients Undergoing LASIK Surgery
|ClinicalTrials.gov Identifier: NCT00909324|
Recruitment Status : Completed
First Posted : May 28, 2009
Results First Posted : March 24, 2011
Last Update Posted : March 24, 2011
|Condition or disease||Intervention/treatment||Phase|
|Dry Eye Syndromes||Drug: Pre-LASIK 0.3% hypromellose Drug: Post-LASIK 0.3% hypromellose||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||162 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy, Tolerability and Comfort of 0.3% Hypromellose Eyedrops in the Pre- and Post-Operative Treatment of Patients Undergoing LASIK Surgery|
|Study Start Date :||August 2009|
|Primary Completion Date :||January 2010|
|Study Completion Date :||January 2010|
|Experimental: Pre-LASIK 0.3% hypromellose||
Drug: 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.
|Active Comparator: Post-LASIK 0.3% hypromellose||
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.
- Change in Ocular Comfort Level From Baseline to End of Study [ Time Frame: Baseline (Pre-LASIK surgery), Day 1, Day 7 and Day 30 post-LASIK surgery ]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.
- Change in Tear Breakup Time From Baseline to End of Study [ Time Frame: Baseline (Pre-LASIK surgery), Day 1, Day 7 and Day 30 post-LASIK surgery ]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.
- Change in the Results of Schirmer's Test From Baseline to End of Study [ Time Frame: Baseline (Pre-LASIK surgery), Day 1, Day 7 and Day 30 post-LASIK surgery ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00909324
|Novartis Investigational Site|
|Delhi, India, 110088|
|Study Director:||Novartis India Ltd.||Novartis India Ltd.|