Efficacy, Tolerability, and Comfort of 0.3% Hypromellose Eyedrops in Patients Undergoing LASIK Surgery
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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|
|Actual Primary Completion Date :||January 2010|
|Actual 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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.|